BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DUROM ACETABULAR COMPONENT 48/42 CODE H

    MDR report key: 3221501 · Received July 9, 2013

    Report

    Report Number
    9613350-2013-01706
    Event Type
    Injury
    Date Received
    July 9, 2013
    Date of Event
    October 26, 2010
    Report Date
    June 28, 2010
    Manufacturer
    ZIMMER GMBH
    Product Code
    KWA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE MANUFACTURER DID NOT RECEIVE DEVICES OR X-RAYS FOR REVIEW. WHERE LOT NUMBERS WERE RECEIVED FOR THE 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. SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE AND AN INVESTIGATION RESULT BE AVAILABLE, THAT CHANGES THIS ASSESSMENT, AN AMENDED MEDICAL DEVICE REPORT WILL BE SUBMITTED. (B)(4).

    Description of Event or Problem · 1

    A PRODUCT LIABILITY CLAIM WAS RAISED. IT WAS REPORTED THAT THE PATIENT WAS IMPLANTED A DUROM ACETABULAR COMPONENT 48/42 CODE H ON THE LEFT SIDE ON (B)(6) 2007. DUE TO PAIN, METALLOSIS AND FLUID, THE PATIENT UNDERWENT REVISION SURGERY ON (B)(6) 2010.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    312261 DUROM ACETABULAR COMPONENT 48/42 CODE H DUROM ACETABULAR COMPONENT KWA ZIMMER GMBH 2362850

    Patients

    Seq Age Sex Outcome Treatment
    1 62 YR Hospitalization| R