inforMED
InjuryKYK

MIC TIB TRAY 26MM R

Received Aug 6, 2007 · Event occurred Jul 9, 2007

Report 1818910-2007-02328 · MDR key 891372

Device

Generic name

87kyk

Model number

NA

Catalog number

869083

Lot number

A65X7

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