BEUDAMED
    FDA Adverse Event Injury Summary report: N

    METASUL LARGE DIAMETER HEAD 46/L

    MDR report key: 1931029 · Received November 26, 2010

    Report

    Report Number
    9613350-2010-00541
    Event Type
    Injury
    Date Received
    November 26, 2010
    Date of Event
    March 12, 2010
    Report Date
    October 27, 2010
    Manufacturer
    ZIMMER GMBH
    Product Code
    KWA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    INFORMATION WAS FORWARDED FROM THE OWNER ESTABLISHMENT, ZIMMER INC, WHICH MARKETS THE DEVICES IN THE U.S. THE MANUFACTURER DID NOT RECEIVE EXPLANTED DEVICES, X-RAYS, OR OTHER SOURCE DOCUMENTS FOR REVIEW. WHERE LOT NUMBERS WERE RECEIVED FOR THE EXPLANTED DEVICES, THE DEVICE HISTORY RECORDS WERE REVIEWED AND FOUND TO BE CONFORMING. A CAUSE FOR THIS SPECIFIC CLINICAL EVENT CANNOT BE ASCERTAINED FROM THE INFORMATION PROVIDED. IT IS NOT SUSPECTED THAT THE ALLEGED EVENT WAS CAUSED BY DEVICE FAILURE. SHOULD ADDITIONAL INFORMATION 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 FURTHER 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 PATIENT UNDERWENT A REVISION SURGERY 2 WEEKS AFTER THA, DUE TO WOUND DEHISCENCE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 METASUL LARGE DIAMETER HEAD 46/L DUROM ACETABULAR COMPONENT AND METASUL KWA ZIMMER GMBH 2536129

    Patients

    Seq Age Sex Outcome Treatment
    1 70 YR Hospitalization