BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DUROM ACETABULAR COMPONENT 50/44 CODE J

    MDR report key: 2081372 · Received April 28, 2011

    Report

    Report Number
    9613350-2011-00275
    Event Type
    Injury
    Date Received
    April 28, 2011
    Date of Event
    March 31, 2011
    Report Date
    April 1, 2011
    Manufacturer
    ZIMMER GMBH
    Product Code
    KWA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    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. SHOULD ADDITIONAL INFO BECOME AVAILABLE AND / OR THE DEVICE(S) BE RETURNED FOR EVAL AND AN INVESTIGATION RESULT BE AVAILABLE, THAT CHANGES THIS ASSESSMENT, AN AMENDED MEDICAL DEVICE REPORT WILL BE FILED. THE NEED FOR FURTHER CORRECTIVE MEASURE 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 PT HAD PAIN IN THE THIGH, AND FEMORAL CYST ON X-RAY INDICATED THE NEED FOR REVISION. PT WAS REVISED ON (B)(6) 2011.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 DUROM ACETABULAR COMPONENT 50/44 CODE J DUROM ACETABULAR COMPONENT AND METASUL KWA ZIMMER GMBH 2307980

    Patients

    Seq Age Sex Outcome Treatment
    1 64 YR Hospitalization