BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ZIMMER M/L TAPER HIP PROSTHESIS WITH KINECTIV TECHNOLOGY MODULAR FEMORAL STEM PR

    MDR report key: 1083282 · Received July 28, 2008

    Report

    Report Number
    1822565-2008-00453
    Event Type
    Injury
    Date Received
    July 28, 2008
    Date of Event
    June 18, 2008
    Report Date
    July 7, 2008
    Manufacturer
    ZIMMER, INC.
    Product Code
    KWY
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    EVALUATION SUMMARY: CAUSE CANNOT BE DEFINITIVELY DETERMINED. 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 INFO, THE NEED FOR CORRECTIVE ACTION IS NOT INDICATED. SHOULD ADDITIONAL SUBSTANTIVE INFO BE RECEIVED, THE COMPLAINT WILL BE REOPENED. ZIMMER CONSIDERS THE INVESTIGATION CLOSED.

    Description of Event or Problem · 1

    IT IS REPORTED THAT THE DEVICE WAS IMPLANTED IN 2008. APPROX 4 WEEKS POST-OP, THE FEMORAL SHAFT FRACTURED. THE STEM WAS REVISED ON THE FOLLOWING MONTH, WITH ORIF.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ZIMMER M/L TAPER HIP PROSTHESIS WITH KINECTIV TECHNOLOGY MODULAR FEMORAL STEM PR HIP PROSTHESIS KWY ZIMMER, INC. NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 86 YR Hospitalization| R