BEUDAMED
    FDA Adverse Event Other Summary report: N

    DUROM ACETABULAR COMPONENT

    MDR report key: 2181533 · Received July 6, 2011

    Report

    Report Number
    9613350-2011-00450
    Event Type
    Other
    Date Received
    July 6, 2011
    Date of Event
    January 25, 2011
    Report Date
    June 21, 2011
    Manufacturer
    ZIMMER GMBH
    Product Code
    KWA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    INFORMATION WAS FORWARDED FROM THE OWNER ESTABLISHMENT, ZIMMER (B)(4) , WHICH MARKETS THE DEVICES IN (B)(4). THE MANUFACTURER DID NOT RECEIVED DEVICES, X-RAYS, OR OTHER SOURCE DOCUMENTS FOR REVIEW. SINCE NO LOT NUMBERS WERE RECEIVED FOR THE DEVICE RELATED TO THIS CASE, THE DEVICE HISTORY RECORDS COULD NOT BE REVIEWED. THE CAUSE FOR THIS SPECIFIC CLINICAL EVENT CANNOT BE ASCERTAINED FROM THE INFORMATION CURRENTLY PROVIDED. SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE AND/OR THE DEVICE(S) BE RETURNED FOR EVALUATION 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. (B)(4).

    Description of Event or Problem · 1

    IT IS REPORTED THAT THE PATIENT UNDERWENT TOTAL HIP RESURFACING ON (B)(6) 2008. IT IS ALSO REPORTED THAT THE PATIENT EXPERIENCED PAIN. SURGICAL REVISION WAS CONDUCTED ON (B)(6) 2010, LOOSENING WAS OBSERVED.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 33 YR Other