Stryker Orthopaedics Recalls Rejuvenate Modular Hip SystemIn July 2012, Stryker Orthopaedics voluntarily recalled its Rejuvenate Modular Hip System. The recall includes both Stryker’s Rejuvenate Modular and ABG II modular-neck hip stems.
RisksStryker initiated this voluntary recall due to potential risk associated with modular-neck stems. This risk includes:
- possible fretting and/or corrosion at the modular-neck junction, which may result in pain and/or swelling.
- Joint loosening/dislocation
- Device wear and tear, such as corrosion and fretting
- Excessive metal debris leading to metal ion generation
- Inflammation of tissue
- Hypersensitivity/allergic response
- Broken devices
History of Problems with Stryker’s Hip ImplantsStryker Orthopaedic’s voluntary recall follows a May 2012 Health Canada recall and an April 2012 Urgent Safety Alert that Stryker released about serious health risks associated with the product.
The FDA issued warnings to the company from 2005 – 2007 before instituting, in January 2008, a nationwide recall of parts manufactured for use in the socket portion of hip replacements. The FDA recalled the products citing reports that the methods used in Stryker’s manufacturing plants did not conform with good manufacturing practices and that ‘manufacturing residuals’ at levels that exceeded company standards could contaminate the components.