BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DUROM HIP

    MDR report key: 2035844 · Received March 2, 2011

    Report

    Report Number
    9613350-2011-00112
    Event Type
    Malfunction
    Date Received
    March 2, 2011
    Report Date
    November 22, 2010
    Manufacturer
    ZIMMER GMBH
    Product Code
    KWB
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    INFO WAS FORWARDED FROM THE OWNER ESTABLISHMENT, ZIMMER INC., WHICH MARKETS THE DEVICES IN THE U.S. CASE WAS REPORTED WITH REPORT NUMBER 1822565-2010-01439 FROM ZIMMER INC WHEREAS IT SHOULD HAVE BEEN REPORTED FROM ZIMMER (B)(4). THE SPECIFIC DEVICE HAS NOT BEEN RETURNED FOR REVIEW AND THE LOT NUMBER HAS NOT BEEN PROVIDED. THEREFORE, THE DEVICE HISTORY RECORD CANNOT BE REVIEWED. IT IS NOT SUSPECTED THAT DEVICE FAILURE LEAD TO THE ALLEGED EVENT. SHOULD ADDITIONAL INFO BECOME AVAILABLE AND/OR THE DEVICE(S) BE RETURNED FOR EVALUATION AND AN INVESTIGATION RESULT BE AVAILABLE, THAT CHANGES THIS ASSESSMENT, AN AMENDED MEDICAL DEVICE REPORT WILL BE FILED. THE NEED FOR CORRECTIVE MEASURES IS NOT INDICATED AT THIS TIME AND ZIMMER (B)(4) CONSIDERS THIS CASE CLOSED. (B)(4).

    Description of Event or Problem · 1

    IT IS REPORTED THAT THE IMPACTOR PADS FRACTURED DURING USE. NO PT HARM HAS BEEN REPORTED. NO PRODUCTS WILL BE RETURNED FOR EVALUATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 DUROM HIP ORTHOPEDIC MANUAL SURGICAL INSTRUMENT KWB ZIMMER GMBH UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 Other