BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DUROM ACETABULAR COMPONENT

    MDR report key: 2151542 · Received June 28, 2011

    Report

    Report Number
    9613350-2011-00421
    Event Type
    Injury
    Date Received
    June 28, 2011
    Report Date
    May 20, 2011
    Manufacturer
    ZIMMER GMBH
    Product Code
    KWA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    INFO WAS FORWARDED FROM THE OWNER ESTABLISHMENT, ZIMMER (B)(4), WHICH MARKETS THE DEVICES IN THE U.S. THE MFR DID NOT RECEIVE THE SPECIFIC DEVICE RELATED TO THIS CASE, X-RAYS, OR OTHER SOURCE DOCUMENTS FOR REVIEW. SINCE NO PRODUCT LOT NUMBERS WERE RECEIVED, THE DEVICE HISTORY RECORDS COULD NOT BE REVIEWED. THE CAUSE FOR THIS SPECIFIC CLINICAL EVENT CANNOT; THEREFORE, BE ASCERTAINED FROM THE INFO CURRENTLY PROVIDED. 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. ZIMMER (B)(4) CONSIDERS THIS CASE CLOSED. ZIMMER REFERENCE NUMBER OF THIS FILE IS (B)(4).

    Description of Event or Problem · 1

    IT IS REPORTED THAT THE PT UNDERWENT A REVISION SURGERY ON THE LEFT HIP.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 DUROM ACETABULAR COMPONENT DUROM ACETABULAR COMPONENT AND METASUL KWA ZIMMER GMBH UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization