Stryker Hip Implant Attorneys
On November 28, 2007 the FDA issued a warning letter to Stryker Howmedica Osteonics Corp. for failure to establish and maintain procedures for identifying all of the actions needed to correct and prevent the recurrence of nonconforming product and other quality problems, and verifying or validating the corrective and preventive action to ensure that such action is effective as well as failure to establish and maintain procedures for monitoring and control of process parameters for validated processes to ensure that the specified requirements continue to be met. This is the second warning letter issued to Stryker by the FDA, the first coming in March of 2007.
The Stryker Corporation, located in Mahwah , New Jersey , manufactures medical devices such as hip implants and implant components. The FDA said that Stryker failed to comply with their manufacturing rules, stating that Stryker received continual complaints from January of 2005 through May of 2007 concerning devices that have failed to function and concerning hip implant components that have poor fixation. The letter also stated that in some instances, the problems with these devices have required revision surgeries. Some of the complaints received between January of 2005 through April of 2007 involved squeaking noises of hip implants with ceramic bearing components; some of those problems resulted in revision surgeries due to implant failures (fractures, pain, wear particles, and fragments).
This is not the first time a problem has been associated with Stryker medical devices. In August of 2001 the FDA is announced a voluntary recall of the unimplanted inventory of nine batches of zirconia ceramic femoral heads manufactured by a French manufacturer, Saint Gobain Advanced Ceramics Desmarquest (St. Gobain Desmarquest), and by U.S. manufacturers that have included these components in their hip prostheses. The component is the "ball" portion of the hip prosthesis that connects the femoral stem to the pelvis. Stryker was one of the U.S. manufacturers who used the faulty components which were recalled due to a potential fracture problem. St. Gobain Desmarquest recalled the zirconia ceramic femoral head component in August 2001 after noticing it was fracturing at a higher rate than expected in some patients.
If you or someone you love have suffered from a malfunctioning Stryker Hip Implant, contact our service immediately. We can help put you in touch with experienced attorneys who can help you with your case.
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