BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MIS REPLACEMENT FEM INSERTER/EXTRACTOR PAD

    MDR report key: 1812422 · Received August 17, 2010

    Report

    Report Number
    1822565-2010-00594
    Event Type
    Malfunction
    Date Received
    August 17, 2010
    Date of Event
    March 8, 2010
    Report Date
    July 19, 2010
    Manufacturer
    ZIMMER, INC.
    Product Code
    LXH
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MS, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    EVALUATION SUMMARY: IMPACTORS BECOME DAMAGED THROUGH REPEATED USE DUE TO IMPACTIONS SUSTAINED WHILE IN USE. IMPACTOR HEADS SHOULD BE REPLACED WHEN THE PART IS NO LONGER FUNCTIONING. FAILURE CAN BE ATTRIBUTED TO NORMAL WEAR AND TEAR. WITHOUT ADDITIONAL INFORMATION, THE EXACT CAUSE CANNOT BE CONCLUSIVELY DETERMINED AT THIS TIME. EVALUATION CODES: NO PRODUCT WAS RETURNED. REVIEW OF THE DEVICE HISTORY RECORDS WAS ALSO NOT POSSIBLE AS THE PRODUCT AND/OR LOT NUMBERS REQUIRED FOR RETRIEVAL WERE UNAVAILABLE. 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 AVAILABLE INFORMATION, THE NEED FOR CORRECTIVE ACTION IS NOT INDICATED. SHOULD ADDITIONAL SUBSTANTIVE INFORMATION BE RECEIVED, THE COMPLAINT WILL BE REOPENED. ZIMMER, INC. CONSIDERS THE INVESTIGATION CLOSED.

    Description of Event or Problem · 1

    IT IS REPORTED THAT THE BLUE IMPACTION PAD WAS BROKEN WHILE IMPACTING FEMUR.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MIS REPLACEMENT FEM INSERTER/EXTRACTOR PAD KNEE INSTRUMENT LXH ZIMMER, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1