BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DUROM ACETABULAR COMPONENT 54/48 CODE N

    MDR report key: 3231957 · Received July 4, 2013

    Report

    Report Number
    9613350-2013-01705
    Event Type
    Injury
    Date Received
    July 4, 2013
    Date of Event
    February 4, 2010
    Report Date
    June 28, 2013
    Manufacturer
    ZIMMER GMBH
    Product Code
    KWA
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE MFR DID NOT RECEIVE DEVICES OR X-RAYS FOR REVIEW. OTHER SOURCE DOCUMENTS (SURGICAL REPORT) WERE PROVIDED. WHERE LOT NUMBERS WERE REC'D 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 INFO PROVIDED. SHOULD ADD'L INFO BECOME AVAILABLE AND AN INVESTIGATION RESULT BE AVAILABLE, THAT CHANGES THIS ASSESSMENT, AN AMENDED MEDICAL DEVICE REPORT WILL BE SUBMITTED. ZIMMER'S REFERENCE NUMBER OF THIS FILE IS (B)(4).

    Description of Event or Problem · 1

    A PRODUCT LIABILITY CLAIM WAS RAISED. IT WAS REPORTED THAT THE PT WAS IMPLANTED A DUROM ACETABULAR COMPONENT 54/48 CODE "N" ON THE LEFT SIDE ON (B)(6) 2008. DUE TO INFECTION, THE PT UNDERWENT REVISION SURGERY ON (B)(6) 2010.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    306589 DUROM ACETABULAR COMPONENT 54/48 CODE N DUROM ACETABULAR COMPONENT KWA ZIMMER GMBH 2414221

    Patients

    Seq Age Sex Outcome Treatment
    1 59 YR Hospitalization| R