BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PIN/BUSHING REPLACEMENT KIT

    MDR report key: 1694235 · Received May 18, 2010

    Report

    Report Number
    1822565-2010-00358
    Event Type
    Injury
    Date Received
    May 18, 2010
    Date of Event
    March 29, 2010
    Report Date
    March 30, 2010
    Manufacturer
    ZIMMER, INC.
    Product Code
    KWJ
    Removal / Correction Number
    NA
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B) (4): EVAL SUMMARY: PARTS WERE IN VIVO 1.5+ YEARS AND ALL PIECES INCLUDING POLY PIECES WERE STEAM AUTOCLAVED PRIOR TO RETURN. NO POST OPERATIVE X-RAY OR ANY OTHER VISUAL MEANS HAS BEEN PROVIDED TO CONFIRM WHETHER LOCKING OF THE PIN OCCURRED IN THE FIRST PLACE. THE COMPLAINT STATES THAT THE COMPONENT IS NOT ALIGNED. IMPROPERLY ALIGNED HUMERAL AND ULNAR COMPONENTS COULD CAUSE ADD'L STRESS ON THE PINS AND BUSHINGS. THE USE OF EARLIER REVISION KITS WOULD NOT HAVE IMPROVED THE ALIGNMENT. THE EXACT CAUSE CANNOT BE DETERMINED WITH CERTAINTY. REVIEW OF THE DEVICE HISTORY RECORDS DID NOT FIND ANY DEVIATIONS OR ANOMALIES. IT IS NOT SUSPECTED THAT THE PRODUCT FAILED TO MEET SPECIFICATIONS. THE INVESTIGATION COULD NOT VERIFY OR IDENTIFY ANY EVIDENCE OF PRODUCT CONTRIBUTION TO THE REPORTED PROBLEM. BASED ON THE INVESTIGATION, THE NEED FOR CORRECTIVE ACTION IS NOT INDICATED. SHOULD ADD'L SUBSTANTIVE INFO BE REC'D, THE COMPLAINT WILL BE REOPENED. ZIMMER, INC. CONSIDERS THE INVESTIGATION CLOSED.

    Description of Event or Problem · 1

    PIN WAS REPLACED DUE TO WEAR AND BECAUSE ULNA COMPONENT WAS NOT ALIGNED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PIN/BUSHING REPLACEMENT KIT EXTREMITY PROSTHESIS KWJ ZIMMER, INC. NA 60996790

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention