BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TRABECULAR METAL REVERSE BASE PLATE

    MDR report key: 2033484 · Received March 24, 2011

    Report

    Report Number
    1822565-2011-00744
    Event Type
    Injury
    Date Received
    March 24, 2011
    Report Date
    February 26, 2011
    Manufacturer
    ZIMMER, INC.
    Product Code
    KWT
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    EVAL SUMMARY: IT IS UNLIKELY IF THE FRACTURE IS DUE TO NORMAL DAILY ACTIVITY OR IF THE PT EXPERIENCED TRAUMA. THE EXACT CAUSE OF THE FAILURE CANNOT BE DETERMINED WITH CERTAINTY DUE TO INSUFFICIENT INFO. EVAL: 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 ADDITIONAL SUBSTANTIVE INFO BE RECEIVED, THE COMPLAINT WILL BE REOPENED. ZIMMER, INC. CONSIDERS THE INVESTIGATION CLOSED.

    Description of Event or Problem · 1

    IT IS REPORTED THAT REVISION SURGERY IS PENDING DUE TO FRACTURE OF THE BASE PLATE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TRABECULAR METAL REVERSE BASE PLATE KWT ZIMMER, INC. 61370945

    Patients

    Seq Age Sex Outcome Treatment
    1 Other