BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DUROM HIP

    MDR report key: 1945321 · Received December 23, 2010

    Report

    Report Number
    1822565-2010-01439
    Event Type
    Malfunction
    Date Received
    December 23, 2010
    Report Date
    November 22, 2010
    Manufacturer
    ZIMMER, INC.
    Product Code
    KWA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    INFORMATION WAS FORWARDED FROM THE OWNER ESTABLISHMENT, ZIMMER INC. , WHICH MARKETS THE DEVICES IN THE U.S. 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 THE DEVICE FAILURE LEAD TO THE ALLEGED EVENT. SHOULD ADDITIONAL INFORMATION BECOMES 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. ZIMMER REFERENCE NUMBER OF THIS FILE IS (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 KWA ZIMMER, INC. UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 Other