InjuryKYK
MIC UNI FM 60AP CRCO
Received Aug 6, 2007 · Event occurred Jul 9, 2007
Report 1818910-2007-02327 · MDR key 891371
Device
Product problems
- Component(s), worn
- Implant, removal of
Patient
NA YR
- Unknown (for use when the patient's condition is not known)
Narrative
Description of Event or Problem
THE PT WAS REVISED BECAUSE OF POLY WEAR AND METALOSIS.
Additional Manufacturer Narrative
EXAMINATION WAS NOT POSSIBLE AS NO PRODUCT WAS RETURNED. ALTHOUGH THE EXACT ROOT CAUSE COULD NOT BE DETERMINED, IT WOULD NOT BE UNREASONABLE TO EXPECT SOME WEAR AFTER APPROX. 15 YEARS OF IMPLANTATION. THE NEED FOR CORRECTIVE ACTION IS NOT INDICATED. THE PRODUCT CODES PROVIDED ARE OBSOLETE ITEMS.
Remedial action
- Other