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Published 2/1/2008

Patient Safety Member Alert

Stryker issues voluntary recall of Trident® Hemispherical Shells

On Jan. 28, 2008, the AAOS issued the following Patient Safety Member Alert:

Stryker Orthopaedics has issued a voluntary recall of all Trident® Hemispherical Shells manufactured at their Cork, Ireland, facility between January 2000 and December 2007. The recall, initiated by Stryker on January 21, 2008, is in response to a recent cleaning process evaluation conducted at the Cork, Ireland, facility that revealed that some parts tested exceeded the internal acceptance criteria for manufacturing residuals. The result of exceeding these manufacturing residuals values presents the potential hazard that the device may not achieve biological fixation.

The Trident® Hemispherical Shells affected by this recall include all lot codes with an expiration date between January 2005 (2005-01) and December 2012 (2012-2) and those with catalog numbers 500-01, 502-11, 502-01, 508-11. Stryker Orthopaedics, based on expert opinion of current and historical data, believes that patients implanted with the affected product are not at increased risk.

Stryker is working to contact all institutions and surgeons who have used this product. Stryker is asking surgeons who are aware of any clinical issues related to the Trident® Hemispherical Shells to contact the company at 1-800-OR-ASSIST to complete a report.

Adverse reactions or quality problems experienced with the use of this product may also be reported to the U.S. Food and Drug Administration’s MedWatch Adverse Event Reporting (www.accessdata.fda.gov/scripts) program.

In cases of recalled implant devices, care should be taken to confirm the device’s failure when considering revision surgery as a treatment option. The risks of re-operation are significant and must be carefully assessed and discussed with the patient before treatment is administered.

Questions should be directed to Katherine Sale, AAOS Manager of Biomedical Research and Regulation, at sale@aaos.org or (847) 384-4327.