Stryker Sales Drop Following Hip Implant Recalls

Medical device maker, Stryker Corp. reported a third-quarter sales dip following a recall of two of its hip implant devices.

Sales of Stryker’s reconstructive joint devices dropped one percent in all and its international markets reported the worst performance with artificial hip sales dropping 9.6 percent and knee implants down 4.3 percent, said the Wall Street Journal, said DrugWatch.

We recently wrote that Stryker’s recalled Rejuvenate and ABG II Modular-Neck Hip Implant Stems are prone to early failure and metal corrosion that puts hip replacement patients at risk for suffering from adverse tissue reactions, including metallosis. This July, said DrugWatch, Stryker recalled its Rejuvenate and ABG II modular-neck stems, components in hip replacement systems.

Although the Rejuvenate and ABG II are not constructed with the same defective hip implant design seen in other recalled devices, they do have a common element, said DrugWatch. The Stryker components have all-metal conjunctions; these are similar to designs blamed in defective DePuy and Zimmer hip implants.

The national law firm, Parker Waichman LLP, recently warned hip replacement patients of the potential for corrosion and adverse local tissue reactions linked to Stryker’s recalled Rejuvenate and ABG II Modular-Neck Hip Implant Stems. A report released by Stryker this May, indicated that these devices—modular metal neck stems—are prone to corrosion. This corrosion can lead to both adverse local tissue reactions and “premature failure due to osteolysis, aseptic loosening, and, in some instances, a devastating pseudotumor formation.”

In an announcement this July, Stryker stated that it issued a recall of its Rejuvenate and ABG II Modular-Neck Hip Implant Stems and was ceasing global production of the devices after post-market surveillance indicated that the products were prone to corrosion and fretting that may lead to adverse local tissue reactions. Affected patients may present with symptoms of pain and/or swelling at the local joint site not attributable to other conditions, such as aseptic loosening and periprosthetic sepsis, Stryker said.

The recalled Stryker Rejuvenate and ABG II hip implant components are two-part modular-neck systems consisting of a metal neck within a metal state. The Stryker report released in May advised that patients fitted with modular-neck hip implant systems who experience persistent pain not linked to an infection or other explainable cause should undergo medical evaluations. Assessments “should likely include serum metal ion levels, metal hypersensitivity testing and radiographic analysis including plain radiographs and preferably a metalartifact reducing MRI,” the report stated.

The problems linked to modular-neck hip implant systems, such as Stryker’s Rejuvenate and ABG II components, are significantly similar to problems seen in patients implanted with metal-on-metal hip replacement devices. In those devices, the hip implant’s ball and socket is made entirely of metal. Various studies have revealed that patients implanted with metal-on-metal hip implants may face an increased risk of developing serious complications such as tissue damage, device failure, the need for revision surgery, and long-term disability, all due to the corrosion and shedding of metal ions from the implants’ metal components.

This entry was posted in Defective Medical Devices. Bookmark the permalink.

© 2005-2019 Parker Waichman LLP ®. All Rights Reserved.