BEUDAMED
    FDA Adverse Event Injury Summary report: N

    METASUL HEAD 28 M 12/14

    MDR report key: 2091424 · Received May 4, 2011

    Report

    Report Number
    9613350-2011-00294
    Event Type
    Injury
    Date Received
    May 4, 2011
    Date of Event
    July 31, 2009
    Report Date
    August 14, 2009
    Manufacturer
    ZIMMER GMBH
    Product Code
    KWA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    INFO WAS FORWARDED FROM THE OWNER ESTABLISHMENT, ZIMMER (B)(4), WHICH MARKETS THE DEVICES IN (B)(4). THE MFR 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. IT IS NOT SUSPECTED THAT THE ALLEGED EVENT WAS CAUSED BY PRODUCT FAILURE. SHOULD ADD'L INFO BECOME AVAILABLE AND / OR THE DEVICE (S) BE RETURNED FOR EVAL AND AN INVESTIGATION SHOULD 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 WAS REPORTED THAT THE IMPLANTED DEVICES WERE REVISED BECAUSE THE INFLAMMATION OF THE ILIOPECTINEAL BURSA DEVELOPED THIS YEAR. IT IS ALSO REPORTED THAT ONE OF THE DEVICES THAT WERE REVISED WAS A ZIMMER METASUL HEAD.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 METASUL HEAD 28 M 12/14 EPSILON METASUL 32MM ACETABULAR INSERT KWA ZIMMER GMBH 2221712

    Patients

    Seq Age Sex Outcome Treatment
    1 43 YR Hospitalization