Hip and Knee Replacement Product Recalls
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 Desmarquest’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 government’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 – 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 manufacturer’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 & Nephew’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 “squeaky hips” 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 company’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: • Trident PSL
Acetabular Shells Sulzer Medica Recalls (Now Centerpulse Orthopedics) 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 company’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 Recalls 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, Zimmer’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. Zimmer’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 company’s shareholders filed a class action lawsuit in response to Zimmer’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 patient’s knee. |
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