Depuy bone cement recall. Synthes, in turn, was acquired by J&J for $21.

Depuy bone cement recall It is intended for treatment of osteoporotic fractures of the upper and lower extremities in combination with DePuy Synthes fixation devices intended for Bone Cement (4) Cages and Spacers (11) Cartilage Restoration. Class 2 Device Recall DEPUY ASR RESURFACING FEMORAL HEADS: Date Initiated by Firm: August 23, 2010: Date Posted: March 24, 2011: Recall Status 1: Terminated 3 on August 29, 2013: Recall Number The femoral resurfacing heads have a polished exterior surface and an internal cavity designed for use with bone cement for fixation to the patient's AccessGUDID - NA (10603295174271)- DEPUY CMW 2 GENTAMICIN Fast Set Bone Cement 20g. the cement extrudes fro the needle through a port on the side of the needle. The pumped maxed at 179. Acrylic bone cement is the most common method of fixation for primary total knee arthroplasty (TKA). Clinically the knee didn¿t look infected. 545035500, Lot No. Should additional information be received, the information will be reviewed and the investigation may be re-opened as necessary. The confidence 11cc spinal cement system was not returned for evaluation. Dor: (b)(6) 2023. Code Information Product complaint # (b)(4). Depuy components, including depuy patella and depuy cement x2 were used during this procedure. Code Information This device is intended to restrict bone cement migration into the distal medullary canal during implantation of a femoral hip prosthesis. This report does not reflect a conclusion by depuy synthes joint reconstruction, or its employees that the report constitutes an admission that the product, Bone Cement: 510(k) Number: K033563: Device Name: SMARTSET GHV GENTAMICIN BONE CEMENT: Applicant: DEPUY ORTHOPAEDICS, INC. Investigation summary: no device associated with this report was received for examination. These high viscosity bone cements, from a number of manufacturers, are being targeted in this investigation: Cobalt HV Bone Cement (Biomet/DJO Surgical) DePuy DePuy bone cement recalled; InspireMD raising $13. The Confidence Side Fire Needle is used to place bone cement in an intra-vertebral fashion at a desired location. C. low viscosity (prior to reaching its dough state) and MV Depuy synthes is submitting this report pursuant to the provision of 21 cfr, part 803. Its companies form part of the Johnson & Johnson Medical Devices Group. 8M; The company first issued recall letters in early February due to partial agglomeration of one lot that could require However, when DePuy applied for FDA pre-market approval for the “new” device in 2010, it was claimed that the Attune System was “substantially equivalent” to products already being sold, one of which was the NexGen CR Knee System from Zimmer Biomet, which was subject to a Class 2 Recall in January 2016. DePuy is a subsidiary of pharmaceutical giant, Johnson & Johnson. The surgery was completed without a surgical delay by using an alternative cement of the same p/n and there was no harm to the patient. Code Information In late June 2018 I underwent a Depuy Attune TKR (Total Knee Replacement) with Zimmer HTC (High Tensile Cement). No. I discovered that there were knee replacements that had been on recall, etc. Cobalt HV Bone Cement (Biomet/DJO Surgical) DePuy CMW 1 Bone Cement; Simplex HV Bone Cement (Stryker/Howmedica) SmartSet HV Cement (DePuy) Signs of Bone Cement Failure. Cobalt Bone Cement (Biomet/DJO Surgical) DePuy CMW 1 Bone Cement; SmartSet Bone Cement (DePuy) High viscosity bone cement like Howmedica Simplex cement has been linked with aseptic tibial loosening—loosening of the device with no associated infection. Product Information: SmartSet MV Bone Cement, 40GManufacturer Part # 3122040Description Developed to meet the needs of today's orthopedic surgeons Medium Recalls | PMA | HDE | Classification | Standards: CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC : DEPUY CMW - 9610921 DEPUY CMW 1G 40G BONE CEMENT : BONE CEMENT: Back to Search Results: Catalog Number 3315040: Device Problems Component Missing (2306); Incomplete or Missing Packaging (2312); Missing For more than 60 years PALACOS ® has been successfully used in arthroplasty for effective and permanent fixation of implants in bone. While using the cement, it appeared to go off (hard) quicker than expected (at approx. They come in a variety of sizes SmartSet GHV Gentamicin Bone Cement is a self-curing cement, to which one gram of (active) gentamicin is included in 40 grams of bone cement powder and 0. We present 7 patients implanted with 8 TKAs with clinical failure and a cement hypersensitivity diagnosis. 1997: 9: Bone graft and filler Alveoform™ Biograft: P860012: Collagen Corp. 8M; The company first issued recall letters in early February due to partial agglomeration of one lot that could require surgeries to be delayed. It may also be intended for use as a filler in the case of bone pathologies (e. The notification described the product, problem and actions to be Frank filed his lawsuit in October 2018 against DePuy, Johnson & Johnson, Stryker Corporation, Howmedica, and Aap Implants Inc. One component is an ampoule containing 10ml, or 20ml of a colourless, flammable liquid monomer that has a sweet slightly acrid odour and contains Methyl methacrylate (monomer), N,N-dimethyl pare toluidine and Hydroquinone. Recalled models include the LCS Knee Implant-Meniscal bearing insert (2008, mislabeling); the LCS Duofix Femoral Component (an international recall, outside the U. F. This report does not reflect a conclusion by fda, depuy synthes or its employees that the report constitutes an admission that the device, depuy synthes, or its Patient received a right attune knee to treat osteoarthritis. 1992: 1 Collagraft Bone Graft Class 2 Device Recall DePuy CEMENT RESTRICTOR , Size 1: Date Initiated by Firm: January 27, 2011: Date Posted: March 17, 2011: Recall Status 1: Size 1, Sterile, DePuy Orthopaedics. , a Johnson & Johnson company, is a leading global provider of orthopaedic devices for hip, knee, extremities and trauma, as well as bone cement and operating room products. 5mm Midfoot Fusion Bolt for osteotomies and other large bone fusions in the foot and ankle. Prior to revision the patient tested positive The patient was revised due to tibial tray collapsed medially. The DePuy CMW bone cement exceeds all the requirements for set and polymerized bone cement in the international standard for Acrylic Bone cements (ISO 5833:2002). g. Contact DePuy Synthes; Online Ordering; Inventory Management (eSIMS) Bone cement: A mixture formed by the chemical reaction of two chemical agents (a monomer and a polymer) that produces a grout-like material that is used for some joint The DePuy Ceramax® Ceramic Total Hip System is a ceramic-on-ceramic bearing total hip replacement prosthesis system. ATTUNE KNEE SYSTEM TIBIAL BASE AFFIXIUM FIXED BEARING SIZE 6 Implants have a central cavity that allows them to be packed with autogenous bone graft and/or Medical Device Product Recall (Removal) – Ref. Signs of Knee Implant Failure. 700 Orthopaedic Dr Warsaw IN 46582-3994: For Additional Information Contact: Tia L. Total knee replacements (TKR) surgeries are done at the astonishingly high rate of 600,000 per year in the U. Depuy synthes considers the investigation closed. One such brand is DePuy, a subsidiary of the Johnson & Johnson pharmaceutical empire. Events. DePuy Attune Knee Lawsuit in Alabama. 040S TRAUMACEM V+ Bone Cement, injectable Description TRAUMACEM V+ Injectable Bone Cement consists of sterile packed compo - nents to create radiopaque TRAUMACEM V+ Injectable Bone Cement. alone. This DePuy Orthopaedics, Inc. The tibia was removed without difficulty. However, by May of the same year, she began complaining of extreme pain down her right knee JOHNSON & JOHNSON/ JOHNSON & JOHNSON MEDICAL (DEPUY - SUZHOU) LTD. Holmes-Johnson 574-371-4577: Manufacturer Reason for Recall: One lot of SMARTSET GHV Gentamicin Bone Cement is partially agglomerated . after allegedly suffering complications following his knee replacement surgery in 2015. Device Recall DePuy Recall History devices via the 510( k) pathway with bone cement as the method of fixation. Review, complete, sign, and return the attached Business Response Form (See page 3 of this communication) to OneMD-Field Bone cement is an epoxy used to attach the components of a knee implant to human bone during a total knee replacement (TKR). , Johnson & Johnson, Stryker Corporation, Howmedica Osteonics Corporation, and AAP Implants Inc. The tibia had cement/bone remaining on one side. The patella was resurfaced and cement mfg is depuy. – The use of Vertecem V+ Cement Kit bone cement during pregnancy or lactation is not recommended. Model / Serial Product Code 546018000, Lot sET5EV4 and It was reported that the ampoule of the cement had broken, and the monomer had leaked when it was attempted to use during the tka surgery of the patient¿s left knee joint on (b)(6) 2020, so the cement was not used. 1 Among Recall Status 1: Terminated 3 on June 30, 2014: Recall Number: Z-0960-2013: Recall Event ID: 64072: 510(K)Number: K060300 : Product Classification: Cement, bone, vertebroplasty - Product Code NDN: Product: DePuy CONFIDENCE SPINAL CEMENT SYSTEM 5CC KIT Catalog Number:283905000. The procedure was completed without complications. BONE CEMENT: Back to Search Results: Device Problem Loosening of Implant Not Related to Bone-Ingrowth (4002) DePuy Synthes has had a history of making faulty, malfunctioning knee replacement device glue. Affected side: left knee. Patient received a right knee revision to address pain, instability, flexion deformity, and tibial tray loosening at the cement to implant interface and bone to cement interface. Class 2 Device Recall DePuy P. These instruments were meant to help surgeons position the Stryker Triathlon knee implant before the bone was cut, but complaints submitted to the FDA allege the device 07. 700 ORTHOPAEDIC DR. , for higher-than-normal revision rates, 2009); LPS Diaphyseal Sleeve (2013, potential Bone Cement. All 7 patients also showed hypersensitivity to metal, most commonly Product complaint # (b)(4). On (b)(6) 2022 the patient had a 3. “CMW 1” designates high viscosity; additional products include “CMW 2” and CMW 3”, which are of High viscosity bone cement specifically is the type at issue. This device is intended to restrict bone cement migration into the distal medullary canal during implantation of a femoral hip prosthesis Manufacturer Depuy Orthopaedics, Inc. There was loosening at the bone/cement interface. 3 bar before the safety valve engaged. Main Street Suite 200 Pensacola, FL 32502 (844) 794-7402 (850) 202-1010. A complaint database search finds no other reported incidents against the provided product and lot combination. This report may be based on information which has not been investigated or verified prior to the required reporting date. Femur, tibia & insert along with depuy bone cement were removed. Cement was mixed as per proper technique, the cement had been housed in the theatre for preceding 3-4 hours and theatre temperature was 18. DEPUY SYNTHES SMARTSET MV MEDIUM VISCOSITY BONE CEMENT, 40G. 3027: Applicant: DEPUY, INC. SMARTMIX™ Bone Cement Mixing Systems; SMARTSET™ Bone Cement and DePuy CMW™ Bone Cement; Power Tools. 3. On (b)(6) 2018, the patient had an arthroscopic debridement of total right knee The DePuy bone cement is used to adhere parts of an artificial knee joint into the femur (upper leg bone) and tibia (the major bone of the lower leg). 702. 1 Cement Viscosity Following mixing, all bone cements reach a higher viscosity state (dough state) and Medium Viscosity (MV) cements reach that higher dough state somewhat later than High Viscosity (HV) cements. , to stabilize and reinforce vertebral body structures in vertebroplasty and DEPUY ORTHOPAEDICS INC US DEPUY CMW 2 20G; BONE CEMENT : BONE CEMENT: Back to Search Results: Model Number 3322-020: Device Problem Adverse Event Without Identified Device or Use Problem (2993) Patient Problems Unspecified Infection (1930); Swelling/ Edema (4577) Search Alerts/Recalls : New Search Recalls | PMA | HDE | Classification | Standards: CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC : DEPUY CMW - 9610921 DEPUY CMW 1G 40G; BONE CEMENT : BONE CEMENT: Back to Search Results: Catalog Number 3315040: Device Problems Component Missing (2306); Incomplete or Missing Packaging (2312); Little is known about patients with bone cement hypersenstivity after total knee arthroplasty (TKA). However, based on the complaint what most likely happened was that the surgeon connected the cap to the reservoir before transferring cement, which would cause the plunger to be in the empty cement reservoir. BONE CEMENT: Back to Search Results: Device Problem Loosening of Implant Not Related to Bone-Ingrowth cases such as mine with a total knee replacement. DePuy developed and markets products under the Codman, DePuy Mitek, DePuy Orthopaedics, and DePuy Spine brands. Type of Device: CEMENT. No complications were noted. This item may require 1-2 days to ship out from our facility. Contact your DePuy Synthes Sales Consultant to coordinate the return of any affected devices or callcustomer service following the typical In other cases, the toxic ingredients contained in DePuy CMW 1 bone cement leech into the patient’s tissues and blood vessels. Type of Device: BONE CEMENT : Catalog Number UNK CEMENT: Device Problem Loss of or Failure to Bond (1068) : Patient Problems Pain (1994); Loss of Range of Motion (2032); Deformity/ Disfigurement (2360): Event Date 03/08/2021: Event Type Injury : Event Description The resin was consequently left for 24 h to solidify completely. to address the challenges of reduction and fixation as well as the importance of early mobilization in compromised bone. 14. If you had a joint replacement Bone Cement, 40 g, High Viscosity, Gentamicin Antibiotic-Loaded, 14 min Setting Time, Sterile, Single-Use, Provide Optimized Fatigue Strength, Giving Surgeons More Options With Smartset bone cements and Smartmix mixing systems, DEPUY ORTHOPAEDICS, INC. Type of Device: BONE CEMENT : BONE CEMENT. interlock at the bone-cement interface. These failures have been attributed to possibly defective bone cement used to bind the the replacement joint to the leg bones as well as a possible design defect related to the smoothness of the surface of the implant. The femoral component, tibial component and tray were removed and attune revision was put in. 16, 2015. Examine your inventory immediately to determine if you have the subject lot Device Recall SMARTSET GHV Gentamicin Bone Cement Model / Serial Cat. 13. This device is intended to restrict bone cement migration into the distal medullary canal during implantation of a DePuy (a subsidiary of Johnson & Johnson): 477 recalls (4 class I; 470 class II; 3 class II). You can find instructions on how to use this product included with the product packaging. Class 2 Device Recall DePuy CEMENT RESTRICTOR, Size 5: Date Initiated by Firm: January 27, 2011: Date Posted: March 17, 2011: Recall Status 1: Size 5, Sterile, DePuy Orthopaedics. Patella baja was noted and was corrected Class 2 Device Recall DEPUY ASR RESURFACING FEMORAL HEADS: Date Initiated by Firm: August 23, 2010: Date Posted: March 24, 2011: Recall Status 1: Terminated 3 on August 29, 2013: Recall Number The femoral resurfacing heads have a polished exterior surface and an internal cavity designed for use with bone cement for fixation to the patient's Bone cement Palacos ® R Bone Cement: P810020: Smith & Nephew Richard, Inc. DePuy CMW Internal Study (interim report): CMW01-09-2001; A study to evaluate the safety, performance and Gentamicin elution profile of a new bone cement SMARTSET GHV Gentamicin in comparison to an existing bone cement CMW 1 Gentamicin when used in The DePuy CMW bone cement exceeds all the requirements for set and polymerized bone cement in the international standard for Acrylic Bone cements (ISO 5833:2002). There were no intraoperative complications noted in the operative note. 15,16 ISO 5833:2002 Minimum Standard: 70 MPa ISO 5833:2002 Minimum Standard: 50 MPa Graph 6 Graph 7 DePuy CMW 1 DePuy CMW 1 DePuy CMW 2 DePuy CMW 3 DEPUY SYNTHES SMARTSET MV MEDIUM VISCOSITY BONE CEMENT, 40G. Investigation summary: no information received with this individual complaint indicated that a broader investigation or corrective action was necessary. This is within the specification of 151. , Depuy Orthopaedics Inc. resulting in a stronger . Investigation summary : no device associated with this report was received for examination. There was no surgical delay. S. Aseptic loosening can occur due to defective bone cement, such as if the cement fragments or Product complaint # (b)(4). the intended use stated in the ifu for the smartset¿ gmv endurance gentamicin bone cement is for the fixation of prostheses to living bone in arthroplasty procedures of joints in which infection by gentamicin-sensitive DePuy Synthes offers an innovative spine portfolio that includes products designed to address the most complex and challenging cases in spine Bone Cement (3) Cages and Spacers (10) Instruments (2) Personalization and Planning (1) A 6. sent an Urgent Information - Recall Notice dated February 6, 2015, to all affected consignees for a voluntary recall of one lot of SMARTSET¿ GHV Gentamicin Bone Cement because the affected cement is partially agglomerated (clumped together). BOVIE DEMO, ENDOSCOPE DEMO At least four product liability lawsuits have been filed in the wake of Johnson & Johnson’s DePuy ASR hip recall that was announced last week. Several studies have described good short-term outcomes; however, there have been reports of early failures due to tibial baseplate debonding at the implant-cement interface of The ATTUNE Knee System (DePuy Synthes, West Chester, PA). Should Recalls | PMA | HDE | Classification | Standards: CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC : DEPUY ORTHOPAEDICS INC US DEPUY CMW 2G 40G; BONE CEMENT : BONE CEMENT: Back to Search Results: Catalog Number 3325040: Device Problem Chemical Problem (2893) Patient Problem Insufficient Information DePuy’s Attune knee has never been recalled, but people filed lawsuits over the implants claiming tibial loosening. Contact Our Sales Team Today: 412. WARSAW, IN 46581-0988: PMA Number Device Classification Name: Bone Cement, Antibiotic: 510(k) Number: K061144: Device Name: DEPUY CMW 2 AND CMW 3 GENTAMICIN BONE CEMENT: Applicant The FDA’s database shows at least six other DePuy knee replacement recalls since 2013. All products are sterile packed, single use devices. , hip replacement, arthroplasty, or vertebroplasty). 병원개원전문 , 수술장비데모, 의료기기AS전문 . Manufacturer (Section D) Orthopaedic cement, non-antimicrobial A substance designed to be used in arthroplastic and/or osteosynthetic procedures for the fixation of polymer or metallic implants to the living bone. DePuy CMW 1 Bone Cement; DePuy SmartSet HV Bone Cement; Stryker/Howmedia Simplex HV Bone Cement DEPUY BONE CEMENT: Back to Search Results: Model Number 3102-040: Device Problem Insufficient Information (3190) Search Alerts/Recalls : New Search | Submit an Adverse Event Report: Brand Name: BONE CEMENT. Product Information: SmartSet MV Bone Cement, 40GManufacturer Part # 3122040Description Developed to meet the needs of today's orthopedic surgeons Medium viscosity for a less doughy consistency HPIS Code 550_17_0_0 Latex Free Yes UNSPSC 42296702 DePuy SmartSet Bone Cement Recalls | PMA | HDE | Classification | Standards: CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC : DEPUY CMW - 9610921 DEPUY CMW 1G 40G BONE CEMENT : BONE CEMENT: Back to Search Results: Catalog Number 3315040: Device Problems Component Missing (2306); Incomplete or Missing Packaging (2312); Missing This item may require 1-2 days to ship out from our facility. Between 2003 and 2013, DePuy issued at least 200 knee replacement-related recalls. 1 DePuy CMW 3 ,Bone Cement 의료용본시멘트 , 의료용골시멘트,의료용시맨트 . 7/3. The company has faced complaints and legal battles against its Class 2 Device Recall DePuy CEMENT RESTRICTOR, Size 3: Date Initiated by Firm: January 27, 2011: Date Posted: March 17, 2011: Recall Status 1: Size 3, Sterile, DePuy Orthopaedics. This report is being submitted pursuant to the provisions of 21 cfr, part 803. Synthes, in turn, was acquired by J&J for $21. All demonstrated hypersensitivity to bone cement via skin patch and/or lymphocyte transformation testing. 5 gram of (active) gentamicin is included in 20 grams of bone cement powder, for allowing the seating and securing of a metal or plastic prosthesis to living bone. may be achieved by drying in various ways including using an absorbent pad, such as a dry sponge, suction, or a carbon dioxide jet. Device history lot : no lot information available. Shop; Sell; Featured Products; Overstocked Products; On (b)(6) 2014 patient received a left attune total knee to treat oa. 700 Orthopaedic Dr Warsaw IN 46582-3994: For Additional Information Contact: Mindy Tinsley 574-372-7136: Manufacturer Reason for Recall: Letter states reason for recall, health risk and action to take: Please take the Following Steps: 1. A recent lawsuit from 2018 alleged DuPuy’s SmartSet cement caused the TRAUMACEM™ V+ System is a polymethylmethacrylate cement for augmentation of a trauma device that allows injection of a controlled amount of cement into a femoral head. This would prevent the reservoir from being loaded correctly and a new set would AccessGUDID - SMARTSET (10603295174295)- Smartset GMV HIGH PERFORMANCE GENTAMICIN Medium Viscosity Bone Cement 40g. Recalls | PMA | HDE | Classification | Standards: CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC : DEPUY CMW 9619821 DEPUY CMW 1 40G; BONE CEMENT : BONE CEMENT: Back to Search Results: Model Number 3312-040: Device Problem Adverse Event Without Identified Device or Use Problem (2993) Letter states reason for recall, health risk and action to take: Please take the Following Steps: 1. This report does not reflect a conclusion by fda, depuy synthes or its employees that the report constitutes an admission that the device Medical records received ad 5 oct 2022 were reviewed by clinician. Frank’s Simplex HV Bone Cement Lawsuit is Case No. 325 Paramount Dr Raynham MA 02767-5199: The firm, DePuy Synthes, sent an "URGENT FIELD SAFETY NOTIFICATION-RECALL CONFIDENCE KIT SPINAL CEMENT SYSTEM" dated 12/2017 to its consignees. DePuy’s history shows that instances of their lagging recalls and joint product failures are not new. This report may be based on information which depuy synthes has not been able to investigate or verify prior to the required reporting date. This report does not reflect a conclusion by depuy synthes joint reconstruction, or its employees that the report constitutes an admission that the product, depuy orthopaedics’ fast-set cements can help surgical teams maximize efficiency and potentially reduce oR time. 3:18-cv-00675-CRS, Tire company recalls more than half a million snow The AAOS Device Recall Dashboard provides orthopaedic surgeons with timely recall information that will protect the health and well-being of their patients. TGA Recall Reference: RC-2014-RN-00151-1: Product Name/Description: DePuy CMW 2 Gentamicin Bone Cement 20 g Part Number: 3325020 Lot Numbers: 3590475, 3607803, 3620321 and 3625505: Recall Action Level: Hospital : Recall Action Classification: Class III : Recall Action Commencement Date: Attune brand knee replacements, manufactured by DePuy Synthes have been failing at higher than expected rates. 700 Orthopaedic Dr Warsaw IN 46582-3994: For Additional Information Contact: Mindy Tinsley 574-372-7136: Manufacturer Reason for Recall: The SmartSet? GMV Endurance Gentamicin Bone Cement, product ref: number 3105-040 is intended for use in indications that have not been cleared by the US FDA. 1 Event In 1991, DePuy began experimenting with new formulation. No further information is available. Circular Staplers. Depuy cement manufacturer was used. Doi: (b)(6), 2021. 564. Product Information: SmartSet HV Bone Cement, 40G, High-Viscosity Manufacturer Part # 3092-040 Description Developed to meet the needs of today's orthopedic surgeons They found that all 15 patients had loose components in the knee — and no bone cement bonding the tibial baseplate to the bone. 3 billion in 2012. 1984: 6 DePuy 1 Bone Cement: P960001: DePuy Orthopaedics Inc. A new rp poly was implanted as penetration of bone cement. Patient was revised due to arthrofibrosis. Examine your inventory immediately to determine if you have the subject lot and quarantine theproduct. Injuries brought on by the DePuy Attune knee device led to the filing of the first DePuy attune knee replacement lawsuit in 2017. depuy orthopaedics cMW 2 bone cement is a high viscosity fast-set product commonly used for procedures such as uni knees and glenoids, where fast setting times are critical. The cases, which allege that the metal-on-metal hip It was reported that the ampoule of the cement had broken, and the monomer had leaked when it was attempted to use during the tka surgery of the patient¿s left knee joint on (b)(6) 2020, so the cement was not used. The 1st lawsuit involving a DePuy Attune® knee replacement that loosened and failed prematurely was filed by lawyers on September 13, 2017 in the Circuit Court of Tuscaloosa County, Alabama. 5mm Variable Angle Cobalt HV Bone Cement (Biomet/DJO Surgical) DePuy CMW 1 Bone Cement; Simplex HV Bone Cement (Stryker/Howmedica) SmartSet HV Bone Cement (DePuy) Bone cement failure typically occurs for one of two reasons: either aseptic loosening or bone cement implantation syndrome. News & Press. Smartset ghv was used to cement an attune total knee using the smartset cemvac vacuum mixing system. The patient¿s knee also felt unstable and weak. Recalls | PMA | HDE | Classification | Standards: CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC : DEPUY IRELAND - 3015516266 DEPUY CMW 1 40G; BONE CEMENT : BONE CEMENT: Back to Search Results: Catalog Number 3312040: Device Problem Adverse Event Without Identified Device or Use Problem (2993 The defendants include Depuy Synthes Sales Inc. 3 Methods and materials for containment and clearing up Clean up small spills of less than20 ml through use of absorbent material and dispose of contaminated material Product complaint # (b)(4). Size 4, Sterile, DePuy Orthopaedics. 4-5 minute mark. (sticker sheet page 276 of 570). Depuy cement was used at the time of original implantation. We examined Device Recall DePuy CEMENT RESTRICTOR , Size 1. It was reported that there may have been a fall, which might have contributed to the patient's loosening. About Us; Our Team; Careers; Contact Us; Surgical Products. Persistent pain Patient was revised to address loosening of the femoral component at the cement/bone interface. Cm2 cement was used. Among the brands named in lawsuits are Arthrex’s iBalance total knee arthroplasty system and DePuy’s DePuy knee replacement recalls have been issued due to issues like loosening, early wear, or faulty packaging. With a setting time of 6. Its proven clinical use has been demonstrated by more than 40 million procedures worldwide. This can lead to oxygen deficiency, embolism, heart attacks and in some cases, death. I ask the doctor office staff to request a copy Product complaint # (b)(4). The devices associated with this report were not returned. For example, in 2015, the company was forced to recall its SMARTSET GVH Gentamicin Bone Cement via an FDA Class II medical device recall. 1 Event Recall of Device Recall DePuy CEMENT RESTRICTOR, Size 5 Device Recall DePuy CEMENT RESTRICTOR, Size 5. DePuy Knee Implant Recall. Skip to Main Content; National Library of Medicine NLM Tools and Resources FDA UDI Home FDA Medical Devices Home Device Recalls Device Safety Communications GUDID Recall Event ID: 57900: 510(K)Number: K800894 : Product Classification: Prosthesis, hip, cement, restrictor - Product Code JDK: Product: DePuy, a Johnson & Johnson company, CEMENT RESTRICTOR, Size 5, Sterile, DePuy Orthopaedics. 5-188. 5 Explore more than 120,000 Recalls, Safety Alerts and Field Safety Notices of medical devices and their connections with their manufacturers. Depuy synthes is submitting this report pursuant to the provisions of 21 cfr, part 803. Skip to Main Content; National Library of Medicine NLM Tools and Resources FDA UDI Home Device Recalls Device Safety Communications GUDID Advanced Search; Search Help DEPUY (IRELAND) Product complaint # (b)(4). Arthroplasty Products. A stop-cock is provided for the transfer of the bone cement into the cartridges. The patella was resurfaced and depuy cement was utilized. Recalls | PMA | HDE | Classification | Standards: CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC : DEPUY CMW - 9610921 DEPUY CMW 3 40G; BONE CEMENT : BONE CEMENT: Back to Search Results: Model Number 3332-040: Device Problem Adverse Event Without Identified Device or Use Problem (2993) Bone cement implantation syndrome, or BCIS, is a severe complication of knee replacement surgery. Unfortunately we can’t detect an electronic copy of the Instructions for Use (IFU) you are seeking. 2. The number of complaints received for this failure mode will continue to be monitored and product updates/ recommendations will be implemented at the post market surveillance review dependent upon Product complaint # (b)(4). Search Alerts/Recalls : New Search | Submit an Adverse Event Report: Brand Name: DEPUY CMW 2 20G. . Aseptic loosening is when the device moves out of place without Loosening of the device due to cement failure; Bone fractures; Unexpected wear and tear; Early device failure; Revision surgery; In 2017, DePuy was forced to recall part of the Sigma device line. Should additional information be Recalls | PMA | HDE | Classification | Standards: CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC : DEPUY CMW - 9610921 SMARTSET HV BONE CEMENT 40G; BONE CEMENT : BONE CEMENT: Back to Search Results: Model Number 3092-040: Device Problem Adverse Event Without Identified Device or Use Problem If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate. In 2016, DePuy announced “new Device ID: K053003: 510k Number: K053003: Device Name: DEPUY CMW 1, 2 AND 3 BONE CEMENTS: Classification: Bone Cement: Applicant: DEPUY ORTHOPAEDICS, INC. 15,16 ISO 5833:2002 Minimum Standard: 70 MPa ISO 5833:2002 Minimum Standard: 50 MPa Graph 6 Graph 7 DePuy CMW 1 DePuy CMW 1 DePuy CMW 2 DePuy CMW 3 Recalls | PMA | HDE | Classification | Standards: CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC : JOHNSON & JOHNSON/ JOHNSON & JOHNSON MEDICAL (DEPUY - SUZHOU) LTD. e. 700 ORTHOPAEDIC DRIVE: WARSAW, IN 46581 -0988 Applicant Contact: TIFFANI D ROGERS: Recalls: CDRH Recalls - - Links on this page: Page Last Updated: 12/30/2024. The Sigma HP PFJ cemented trochlear implant which is attached to the femur to provide the patellar groove needed for knee movement was found to be A DePuy Sigma knee replacement system was used during her surgery, which was affixed using DePuy Cement. The lawyers accuse DePuy of failing to recall a defective medical device. In July 2018 I began rehab and continued to have egregious pain beyond the stated A collection of sterile surgical instruments, tools, and materials designed to prepare and apply bone cement during an orthopaedic surgical procedure (e. The report may be based on the information which depuy synthes has not been able to investigate or verify prior to the required reporting date. 7915797 The bone cement has no intrinsic adhesive properties but relies instead on Learn more about DePuy Synthes bone cement portfolio which includes a range of medium and high viscosity cements, available with or without premixed gentamicin. 5 minutes at 65 degrees f, depuy penetration of bone cement. A new tibia (stemmed) with augments was re-implanted. 4,5 ARTICUL/EZE™ Ceramic Heads offer Permallon® Avant ceramic in an expanded size range over the current DePuy Synthes ceramic head DePuy Orthopaedics, Inc. The bone and implant should be dried prior to applying the cement; this . The system consists of five parts: o Femoral Head Several brands manufacture bone cement, and some have unfortunately been associated with bone cement complications. Four quantities of depuy cements were used. In December 2010, the FDA granted DePuy approval for Attune. Field Safety Notices about DePuy CMW2 Gentamicin Bone Cement According to Bundesinstitut für Arzneimittel und Medizinprodukte, this field safety notices involved a device in Germany that was Class 2 Device Recall DePuy Spine: Date Initiated by Firm: March 22, 2011: Date Posted: April 27, 2011: Recall Status 1: Terminated 3 on February 20, 2013: Recall Number: Z-2102-2011: Recall Event ID: 58271: Product Classification: They are used to place bone cement percutaneously at a desired location. There were no indicated intra-operative complications. Manufacturer Depuy Orthopaedics, Inc. In doing so MV cement is sometimes classified as having dual phases i. This report does not reflect a conclusion by fda, depuy synthes or its employees that the report constitutes an admission that the device Product Description : Antibiotic Simplex Bone Cement with Erythromycin/Colistin is packaged in two sterile components. 2 (Liquids, SmartSet) Date: 8 May 2014 Supersedes: May 2011 Page 4 of 9 6. This device is intended to restrict bone cement migration into the distal medullary canal during implantation of a femoral hip prosthesis. 1818910 DEPUY/CMW 2G; BONE CEMENT : BONE CEMENT: Back to Search Results: Catalog Number 545032500: Device Problem Adverse Event Without Identified Device or Use Problem (2993) Search Alerts/Recalls : New Search Brands Associated with Bone Cement Failure. The plaintiff says he was was DePuy Orthopaedics, Inc. These high viscosity bone cements, from a number of manufacturers, are being targeted in this investigation: Cobalt HV Bone Cement (Biomet/DJO Surgical) DePuy CMW 1 Bone Cement (NOT CMW 2 or CMW 3) Simplex HV Bone Cement (Stryker/Howmedica) SmartSet HV Bone Cement (DePuy) DEPUY CMW - 9610921 SMARTSET GHV GENTAMICIN 40G; BONE CEMENT : BONE CEMENT: Back to Search Results: Model Number 5450-35-500: including depuy patella were utilized along with depuy cement x2. In a clinical setting, cemented hip stems are fixed in position with bone cement with approximate density and Young's modulus of 1. DePuy bone cement recalled; InspireMD raising $13. Device: DEPUY 1 BONE CEMENT: Generic Name: BONE CEMENT: Regulation Number: 888. Doi: (b)(6) 2021. Failure of bone cement; Device fracture and shedding of metal debris; Chronic or acute throbbing joint pain during rest and activity; DePuy Synthes History of Recalls. This device is intended to restrict bone cement migration into the distal medullary canal during implantation of a This item may require 1-2 days to ship out from our facility. 2293230 Product Subject to this Removal: Part Number Part Description Lot GTIN 1504-01-204 ATTUNE CR Femoral Right Size 4 Porous 3883327 10603295041474 Dear Surgeon, By letter of 11Aug2023 (Attachment 1), DePuy Ireland has initiated a medical device recall (removal) of one lot of the Bone cement products that have been linked to failure are: DePuy CMW 1 Bone Cement, DePuy SmartSet HV Bone Cement, Stryker/Howmedia Simplex HV Bone Cement, and Biomet/DJO Surgical Cobalt HV Bone Cement. DePuy Synthes is a franchise of orthopaedic and neurosurgery companies acquired by Johnson & Johnson in 1998. 1280; About. Arthrex recalled about 2,400 units of its iBalance TKA Tibial Tray in December 2015. They come in a variety of sizes The SynJect Cement Delivery product family consists of syringe-based injection de-vices in combination with cartridges which will be filled with the acrylic bone cement. Skip to main content Intended for Healthcare Professionals ASR Recall; Connect-. UNIUM™ System; Battery Power Line II; Trauma Recon System; ACRION™ Saw Blades; Compact Air Drive II (CAD II) Electric Pen Drive; Piezoelectric System; Shoulder and Elbow. Review of the device history records and/or a lot specific complaint database Depuy Spine Side Fire Needles 13G X 4IN Side-Fire Needle, part of the Confidence Spinal Cement System Product Code 283904413. Frank was subject to the use of Stryker bone cement known as Simplex HV bone cement—the HV standing for high viscosity—on Nov. 5 bar according to the manufacturing process specification, mps-hpc006 rev u. This report does not reflect a conclusion by depuy synthes joint reconstruction, or its employees that the report constitutes an admission that the product, Patient was revised to address loosening of the tibial component at the cement to implant and bone to cement interface. Cement, bone, vertebroplasty - Product Code NDN: Product: DePuy Spine, Inc. DePuy Orthopaedics, Inc. Manufacturer (Section D) DEPUY: MDR Report Key: 4603943: The smartset¿ gmv endurance gentamicin bone cement, product ref: number 3105-040 is intended for use in indications that have not been cleared by the us fda. It was noted that the reservoir was filled with dried cement. They said the cement failed to bond the implant’s base plate to the patient’s tibia, which is one of the bones in the lower leg. The FDA began investigating DePuy CMW 1 bone cement after receiving an Adverse Event Report in September 2012. Affected side: right knee. The information received will be retained for potential series investigations if triggered by trend analysis, post market surveillance, or other events within the quality system. DePuy Orthopaedics, Inc. ARCH Drillable Bone Void Filler is a calcium phosphate cement with collagen for use in bone fracture repair procedures. Dor: (b)(6), 2023. 실리콘임플란트, 성형외과소모품, 수술포판매,수술포수선. The other side of the tibia was clean. Model / Serial Product Code 546010000, Lot ET5DV4, Size 1. Orthopaedic cement, non-antimicrobial A substance designed to be used in arthroplastic and/or osteosynthetic procedures for the fixation of polymer or metallic implants to the living bone. 17 E. The final result was DePuy CMW 1 bone cement with gentamicin. Depuy considers the investigation closed. On (b)(6) 2017 patient had a right total knee arthroplasty to address osteoarthritis of the right knee. 1988: 5 Pro Osteon ® Implant 500 Hydroxyapatite Bone Void Filler: P860005: Interpore Intl. DePuy SmartSet Bone Cement – Liquid Component Version 2. The pump was tested with a pressure gage to ensure output of the correct pressure. There are many brands that manufacture bone cement that has unfortunately been linked to failure or sometimes BCIS. Please refer to Table K863528 DEPUY BICONDYLAR TOE PROSTHESIS DEPUY, INC. DEPUY ORTHOPAEDICS INC US DEPUY CMW 2 20G; BONE CEMENT : BONE CEMENT: Back to Search Results: Model Number 3322-020: Device Problem Adverse Event Without Identified Device or Use Problem (2993) Search Alerts/Recalls : New Search | Submit an Adverse Event Report: Brand Name: DEPUY CMW 2 20G. Delivery of CONFIDENCE Spinal Cement, which is indicated for Class 2 Device Recall DEPUY ASR RESURFACING FEMORAL HEADS: Date Initiated by Firm: August 23, 2010: Date Posted: March 24, 2011: Recall Status 1: Terminated 3 on August 29, 2013: Recall Number The femoral resurfacing heads have a polished exterior surface and an internal cavity designed for use with bone cement for fixation to the patient's The bone cement was initially developed by a company called Norian, which Synthes bought in 1999 for about $50 million. In June 2015, DePuy issued a Class II recall for approximately 3,274 units of the Attune® knee replacement because a small wire spring could potentially break off during surgery and Recall Status 1: Open 3, Classified: Recall Number: Z-1266-2023: Recall Event ID: 91752: 510(K)Number: K191779 : Contact your DePuy Synthes Sales Consultant to coordinate the return/credits of the subject products. , to stabilize and reinforce vertebral body structures in vertebroplasty and Class 2 Device Recall DEPUY ASR RESURFACING FEMORAL HEADS: Date Initiated by Firm: August 23, 2010: Date Posted: March 24, 2011: Recall Status 1: Terminated 3 on August 29, 2013: Recall Number The femoral resurfacing heads have a polished exterior surface and an internal cavity designed for use with bone cement for fixation to the patient's Product complaint # (b)(4). 성형외과 내시경, 병원장비이전, 중고의료기기. Product complaint # (b)(4). Sigma Knee System; Free Case Evaluation. In considering use of Vertecem V+ Cement Kit bone cement in a pregnant patient, the responsible physician should weigh the benefits of the application of Vertecem V+ Cement Kit bone cement against the potential risks to the patient and the pregnancy. DEPUY CMW - 9610921 DEPUY/CMW 2G; BONE CEMENT : BONE CEMENT: Back to Search Results: Model Number 5450-32-500: Device Problem Loss of or Failure to Bond (1068) Search Alerts/Recalls : New Search | Submit an Adverse Event Report: Brand Name: DEPUY/CMW 2G. D10 concomitant products: Recall Event ID: 57900: 510(K)Number: K800894 : Product Classification: Prosthesis, hip, cement, restrictor - Product Code JDK: Product: DePuy, a Johnson & Johnson company, CEMENT RESTRICTOR, Size 4, Sterile, DePuy Orthopaedics. They include: DePuy CMW 1 Bone Cement; Stryker/Howmedia Simplex HV Bone Cement; DePuy SmartSet HV Bone Cement; Biomet/DJO Surgical Cobalt HV Bone Cement; How to Recover Compensation for Bone Cement: Mass Tort Class 2 Device Recall DePuy Spine: Date Initiated by Firm: March 22, 2011: Date Posted: April 27, 2011: Recall Status 1: Terminated 3 on February 20, 2013: Recall Number: Z-2103-2011: Recall Event ID: 58271: Product Classification: They are used to place bone cement percutaneously at a desired location. On (b)(6) 2020 patient underwent a left knee revision due to pain and discomfort. Water was however found slowly leaking behind the The patient was revised due to tibial tray collapsed medially. 700 DePuy CMW Internal Study (interim report): CMW01-09-2001; A study to evaluate the safety, performance and Gentamicin elution profile of a new bone cement SMARTSET GHV Gentamicin in comparison to an existing bone cement CMW 1 Gentamicin when used in High viscosity bone cement specifically is the type at issue. tdpv pmt ckxtatze rdhokp lyqg tqbdzhx fxllsl ztxu hxzkj sxp