BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ZIMMER MMC CUP 52MM/44MM CODE J

    MDR report key: 2091426 · Received May 4, 2011

    Report

    Report Number
    9613350-2011-00290
    Event Type
    Injury
    Date Received
    May 4, 2011
    Date of Event
    January 1, 2011
    Report Date
    April 12, 2011
    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 (B)(4). 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. FURTHER INVESTIGATION IS NOT POSSIBLE WITH THE GIVEN INFORMATION. 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 ACETABULAR IMPLANT LOOSENED. PATIENT WAS REVISED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ZIMMER MMC CUP 52MM/44MM CODE J ZIMMER MMC CUP KWA ZIMMER GMBH 2517553

    Patients

    Seq Age Sex Outcome Treatment
    1 59 YR Hospitalization