BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DUROM ACETABULAR COMPONENT 52/46 CODE L

    MDR report key: 3223795 · Received July 10, 2013

    Report

    Report Number
    9613350-2013-01716
    Event Type
    Injury
    Date Received
    July 10, 2013
    Date of Event
    January 29, 2013
    Report Date
    July 1, 2013
    Manufacturer
    ZIMMER GMBH
    Product Code
    KWA
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    ATTORNEY
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 1

    THE MANUFACTURER DID NOT RECEIVE DEVICES OR X-RAYS FOR REVIEW. OTHER SOURCE DOCUMENTS (SURGICAL REPORTS) WERE PROVIDED. AS NO LOT NUMBERS WERE PROVIDED FOR THE DEVICES, THE DEVICE HISTORY RECORDS COULD NOT BE REVIEWED. 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 WITH A DUROM ACETABULAR COMPONENT 52/46 CODE L ON THE LEFT SIDE ON (B)(6) 2007. DUE TO FLUID COLLECTION, PSEUDOTUMOR AND METALLOSIS, THE PATIENT WAS REVISED ON (B)(6) 2013.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    314651 DUROM ACETABULAR COMPONENT 52/46 CODE L DUROM ACETABULAR COMPONENT AND METASUL LDH KWA ZIMMER GMBH N/A 2344252

    Patients

    Seq Age Sex Outcome Treatment
    1 60 YR Female Hospitalization| R