Stryker Orthopaedics has recalled two modular neck stem models for hip implants because of the risk of corrosion and wear, which can cause tissue damage. The devices are the modular-neck hip stems ABG II and Rejuvenate. The risks posed by corrosion can lead to hip implant failure.
Pain and swelling at the implant site may indicate adverse tissue reactions caused by the hip implant devices. If you have pain and swelling, you should contact your surgeon immediately.
The neck stems contain metal-on-metal components. These components are susceptible to corrosion and to abrading against one another. Wear and corrosion at the modular-neck junction can cause metal debris and ions to be released into the joint area. The presence of these materials in your body can lead to adverse tissue reactions, including:
- Metallosis, inflammation around metal particles
- Necrosis, death of the tissue
- Osteolysis, which leads to bone loss
- Severe pain
- Allergic reaction for people with metal sensitivity
Adverse tissue reactions and complications caused by corrosion can lead to premature hip implant failure and the necessity for revision surgery.
Stryker decided to recall the modular-neck stems based on post-market data, according to a news release on the FDA website. This data showed that a percentage of patients had to have revision surgeries, possibly due to corrosion and wear at the modular-neck junction.
Stryker’s recall website
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how did these implants get FDA approval?