Stryker Urgent Field Safety Notice Regarding Rejuvenate
Stryker Hip Replacement Recall
In response to the problems noted in the U.S. Food & Drug Administration’s MAUDE database, Stryker issued an Urgent Field Safety Notice for Corrective Action for its Rejuvenate Modular Stems and Necks in April 2012.
According to Stryker:
“This communication is intended to inform implanting and/or treating surgeons and other healthcare professionals that Stryker has updated the Instructions for Use (IFU) for the ABGII Modular and Rejuvenate Modular Hip Systems. This is based on a reported rate of less than one percent for revisions potentially associated with fretting and/or corrosion at or about the modular neck junction.”
The Safety Alert defines the potential hazards as the following:
- Deterioration and/or corrosion at or about the modular neck junction may lead to increased metal ion generation in the surrounding joint space.
- Contact between metal ions and tissues and structures during an implant’s service life may result in an Adverse Local Tissue Reaction (ALTR), the inflammation of associated tissues experiencing immunological response (metallosis, necrosis, and/or pain). An ALTR may result in the need for revision surgery.
- Patients with a heightened sensitivity to these ions may experience a hypersensitivity/allergic reaction which may result in the need for revision surgery.
- Excessive fretting may lead to increased metal debris in the joint space (concentration of debris exceeds individual patient threshold) resulting in osteolysis. Osteolysis may be asymptomatic and may result in the need for revision surgery.
Through this safety notice, Stryker attempted to shift the blame away from its product and place the blame directly on the patient and the surgeon. According to the Safety Alert, the following factors may increase the risk of the above potential hazards:
- Additional femoral offset: This may result in greater relative motion between the neck and stem at the taper junction.
- Solution Chemistry: The local chemistry around an implant may vary considerably from patient to patient. Factors such as diabetes and infection may play a role in potential corrosion of an implant as these conditions may affect the pH of the tissue surrounding the implant. Local pH levels may also influence corrosion.
- Additional weight or excessive patient weight.
- Inadequate locking or assembly of the tapers may lead to an increase in mechanically assisted corrosion.
- Inadequate cleaning of the neck taper may lead to increased debris generation.
- Modular Junctions: Mate modular components firmly to prevent dissociation. Machined taper surfaces must be clean, dry and firmly mated to ensure proper seating and assembly. Repeated assembly/disassembly or failure to clean, dry and firmly mate the components could compromise the taper lock and potentially lead to fretting/corrosion.
If You Have Experienced Metal Poisoning from a Hip Implant, Contact a Stryker Recall Lawyer Today
Even before the Stryker hip replacement recall, the attorneys at Searcy Denney Scarola Barnhart & Shipley PA were investigating claims related to defective metal-on-metal hip implants. We understand the regulatory history of these Stryker hip implants and the adverse health effects and injuries they have caused. If you have experienced a defective hip implant, contact us today. We will fight to secure the compensation you deserve.