UNKNOWN ANKLE TIBIAL INSERT

Additional Manufacturer Narrative

PRODUCT COMPLAINT # (B)(4). INVESTIGATION SUMMARY: NO DEVICE ASSOCIATED WITH THIS REPORT WAS RECEIVED FOR EXAMINATION. A WORLDWIDE LOT SPECIFIC COMPLAINT DATABASE SEARCH, OR DEVICE HISTORY RECORD (DHR) REVIEW, WAS NOT POSSIBLE BECAUSE THE REQUIRED LOT NUMBER WAS NOT PROVIDED. THE INFORMATION RECEIVED WILL BE RETAINED FOR POTENTIAL SERIES INVESTIGATIONS IF TRIGGERED BY TREND ANALYSIS, POST MARKET SURVEILLANCE, OR OTHER EVENTS WITHIN THE QUALITY SYSTEM. (B)(4).

Description of Event or Problem

PATIENT NEEDS TO REVISE (REPLACE) THE BEARING ON A NOW DISCONTINUED MOBILITY ANKLE REPLACEMENT. POLYETHYLENE SPACER APPEARS TO HAVE BROKEN WITHIN THE ANKLE REPLACEMENT.