Depuy Implant Recalls (Now a Subsidiary of Johnson and Johnson) This implant manufacturer was a part of the 2001 recall of zirconia ceramic femoral heads manufactured by St. Gobain Desmarquest. The recall was mandated by the Food and Drug Administration after numerous reports that the femoral head component was fracturing at a larger rate than what was expected. Depuy Orthopedics was one of the eight manufacturers that issued recalls of their hip implant systems as a result of using St. Gobain Desmarquestâ€™s zirconia ceramic femoral heads in their joint replacement products.
In the late 1990s, Depuy withdrew its Hylamer Polyethylene Bearing Surface product from the market. This product was originally developed to minimize wear in join implant components for the hip, shoulders, knees, and elbows. In 2001, the British governmentâ€™s Medical Devices Agency issued a recall of knee implant Hylamer liners sterilized with gamma radiation in air. The recall was conducted after a study showed that patients were showing a high failure rate for the device.
In 2008, Depuy issued another recall on its LCS Knee â€“ Orthopedic knee implant Meniscal bearing insert. This product is intended to replace a knee joint in order to relieve pain and restore function to the knee. The reason for the recall was that the product was not labeled properly and mis-etched as to size.
Smith & Nephew Implant Recalls
This London based medical device manufacturer issued a recall of its Genesis II and Profix II Knee Implants to the Food and Drug Administration in 2003. The recall was a result of the failure of the knee implant systems to bond properly to the bone when implanted. This caused increased pain and loosened joints in patients with the knee implant systems. The failure of these knee implant products led a number of patients to have additional surgeries to fix the problem. These additional surgeries resulted in longer rehabilitation times for the patient and also heightened risks during the operation.
In 2007, Smith & Nephew issued another recall after a subscontractor incorrectly packaged the medical manufacturerâ€™s BIRMINGHAM Hip Resurfacing System implants. As a result of the subcontractor error, different sizes of acetabular cups were packaged together.
Smith & Nephew began another voluntary recall in January of 2008 of its TC-PLUS, VKS, and RT-PLUS product lines. The medical implant manufacturer was informed by one of its suppliers that the semi-finished knee implant castings contained higher-than-specified iron content. The products being recalled were manufactured by Smith & Nephewâ€™s subsidiary, Plus Orthopedics.
Biomet Implant Recalls
Biomet was a part of the 2001 recall of zirconia ceramic femoral heads manufactured by St. Gobain Desmarquest. As mentioned previously, this recall was initiated after authorities had found that the component was breaking at a rate that was higher than expected.
In 2007, Biomet issued a recall of its Tibial Bearing ARCOM UHMWPE, sterile. The reason for this recall was improper laser etching for size.
In 2008, Biomet issued another recall. This recall was on its Biomet brand Modular Microplasty Cup Insterter which is an instrument for its hip prosthesis acetabular cup component. The reason for the recall was that the weld at the lock location could break during impaction.
Encore Orthopedics Recalls
Encore was also a part of the 2001 recall of St. Gobain Desmarquest manufactured zirconia ceramic femoral heads.
In 2004, Encore Orthopedics initiated a recall due to labels being switched on two of its products, Foundation Knee System, and 3DKnee System. The 3D Knee System products were labeled as Foundation Knee Systems and the Foundation Knee Systems were labeled as 3D Knee Systems.
In 2008, Encore Orthopedics recalled its Foundation Knee System Tibial Fixed Impactor component. The reason for the recall is that the company began to receive reports from surgeons that the Nitronic 60 screw on the Tibial Fixed Impactor was fracturing during surgery. Encore initiated another recall in 2008 on its 3DKNEE Tibial Insert Trial, a device used in surgery to determine the right size of 3DKnee component to implant. The Tibial Insert Trial was being incorrectly marked for thickness.
Howmedica Implant Recalls (A Subsidiary of Stryker, Corp.)
Howmedica was one of the manufacturers that had to recall its products due to St. Gobain Desmarquest manufacturing problem with its femoral heads.
In early 2008, Stryker issued a recall on its Trident Hip Implants. The FDA issued a warning in 2007 to Stryker Corporation after patients were complaining that the implant was causing â€œsqueaky hipsâ€ and joint pains. Patients were also reporting that the implants were even breaking and causing the individual difficulty when performing simple tasks such as walking. The complications that some patients were experiencing caused them to have additional surgeries in an attempt to remedy the situation. The recalled implants were being manufactured at the companyâ€™s Ireland facility and sold in the United States. The FDA claims that Stryker failed to fix manufacturing problems which led to problems in patients. According to the FDA, the following list of Stryker products could be defective due to the manufacturing issues:
Stryker issued a recall of the following products:
Trident Acetabular PSL Cup
Trident Hemispherical Cup
Sulzer Orthopedics, a subsidiary of Sulzer Medica, issued a recall in 2001 after the company found a manufacturing error with its knee implant systems. The implants were being contaminated with an oil residue during the manufacturing process. The lubricant residue inhibited the ability for the implant to bond efficiently to neighboring bone. Sulzer reached a $750 million settlement with patients in the United States for this manufacturing error due to the fact that thousands of individuals had to undergo additional surgeries.
Wright Medical Recalls
In 2004, Wright Medical issued a recall on its metal acetabular hip cups that are used in the companyâ€™s CONSERVE(R) Total and CONSERVE(R) Plus hip systems. The reason for the recall was a manufacturer defect that resulted in a seam or ridge in the inner acetabular cup surface. This defect caused the component to fail.
Zimmer was another medical manufacturer that was a part of the St. Gobain Desmarquest manufacturing problem with its zirconia ceramic femoral heads.
In 2008, Zimmer issued a recall on its Durom Cup Replacement product after thousands of the product had already been used in thousands of patients since its approval in 2006. Physicians began to see a problem in their patients when some started complaining about continuous pain after the normal healing timeframe. A number of these patients were forced to have revision surgeries to repair the problem. A few months after the recall, Zimmerâ€™s Durom Cup Replacement was back on the market. However, this time they posted additional product training on their website for physicians. Zimmer claimed that this new training would teach surgeons on how to use their product properly which would cut down on problems. Zimmer admits that it did a poor job at training doctors on using its product when it was first released. Zimmerâ€™s shareholders were also unhappy with the fact that the company took a long time to even notify its stakeholders of the current issues with the Durom Cup product. The companyâ€™s shareholders filed a class action lawsuit in response to Zimmerâ€™s way of handling the situation.
In June of 2008, Zimmer issued another recall, however this time the recall was on its NEXGEN Complete Knee Solution MIS Total Knee Procedure Tibial Broach Impactor. The Tibial Broach Impactor is an instrument used during knee surgery. The firm issued the recall due to findings that the instrument could potentially break during surgery and could leave fragments of metal in the patientâ€™s knee.
Another recall was issued in 2008 for another Zimmer surgical instrument: the Zimmer NEXGEN Complete Knee Solution articular surface insertion instrument. This instrument is used during knee arthroplasty surgeries. This instrument was recalled due to the fact that it could fracture during surgery.
Other Hip replacement recalls:
The entities include: Advanced Bioresearch Association, a regulatory affairs firm consulting with medical device and pharmaceutical companies American Ortomed Corporation, now dissolved Biomet Inc., makers of the M2a-Magnum™ System Large Metal Articulation (Total MOM Hip) and ReCap (Resurfacing Femoral Head , not MOM system), and others no longer marketed C.R. Bard Inc., no current MOM system DePuy Orthopaedics, Inc., a Johnson & Johnson company, makers of ASR (Total Hip, Resurfacing, Recalled); Pinnacle Metal-on-Metal (Total Hip with Ultamet Insert), and others no longer marketed. Downs Surgical Ltd., no current MOM system Encore Medical, now DJO Surgical, makers of metal-on-metal liners for use with FMP acetabular system, and others no longer marketed Endomedics, Inc., no current MOM system Implantology Corporation, no current MOM system Joint Medical Products Corporation, acquired by Johnson & Johnson April 1, 1995 Link America, Inc., no current MOM system Med-Tek Corporation, no current MOM system Orthopaedic Device Corporation, no current MOM system Orthopaedic Manufacturing Company, no current MOM system Osteotechnology, Inc., no current MOM system Pfizer, Inc., no current MOM system Stryker Orthopaedics for Howmedica Osteonics Corp., markets the Cormet Resurfacing System in the US; MITCH PER Mini Hip (resurfacing, not marketed in US) and others no longer marketed Synergy Orthopaedics Intl., Inc., no current MOM system Techmedica, Inc., no current MOM system Turnkey Intergration USA, Inc., no current MOM system Waldemar Link GMBH & Co. KG, no current MOM system Wright Medical Technology, Inc., DYNASTY® Acetabular Cup System with A-CLASS® Metal-on-Metal; Conserve (Partial Resurfacing); Conserve Plus (Total Resurfacing) and others no longer marketed