BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MMC HIP GENERIC

    MDR report key: 2890740 · Received December 21, 2012

    Report

    Report Number
    9613350-2012-01191
    Event Type
    Injury
    Date Received
    December 21, 2012
    Date of Event
    November 19, 2012
    Report Date
    December 10, 2012
    Manufacturer
    ZIMMER GMBH
    Product Code
    KWA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AZ, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE MANUFACTURER DID NOT RECEIVE THE DEVICES FOR REVIEW. AS NO LOT NUMBERS WERE PROVIDED FOR THE DEVICES, THE DEVICE HISTORY RECORDS COULD NOT BE REVIEWED. SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE AND/OR THE DEVICES 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 GMBH CONSIDERS THIS CASE AS CLOSED. (B)(4).

    Description of Event or Problem · 1

    THE PT IS PURSUING A PRODUCT LIABILITY CLAIM ARISING OUT OF THE USE OF THE MMC ACETABULAR CUP. IT WAS REPORTED THAT THE PT RECEIVED A MMC HIP GENERIC ON AN UNKNOWN DATE AND WAS REVISED ON (B)(6) 2012 DUE TO UNKNOWN REASONS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MMC HIP GENERIC ZIMMER MMC CUP KWA ZIMMER GMBH UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R