BEUDAMED
    FDA Adverse Event Other Summary report: N

    DUROM US ACETABULAR COMPONENT 54/48 N

    MDR report key: 2931147 · Received January 22, 2013

    Report

    Report Number
    9613350-2013-01271
    Event Type
    Other
    Date Received
    January 22, 2013
    Date of Event
    January 2, 2013
    Report Date
    January 2, 2013
    Manufacturer
    ZIMMER GMBH
    Product Code
    KWA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AZ, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE MANUFACTURER DID NOT RECEIVE DEVICES, X-RAYS, OR OTHER SOURCE DOCUMENTS 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 INFO PROVIDED. A PRODUCT FAILURE CANNOT BE CONFIRMED. SHOULD ADDITIONAL INFO BECOME AVAILABLE AND/OR THE DEVICES BE RETURNED FOR EVAL AND AN INVESTIGATION RESULT BE AVAILABLE, AN AMENDED MEDICAL DEVICE REPORT WILL BE FILED. A TIGHT MONITORING IS ONGOING FOR REVISIONS WITH U.S. DUROM CUPS WHERE THE INITIAL IMPLANT DATE OCCURRED AFTER THE RELAUNCH OF THE U.S. DUROM CUP. THE NEED FOR FURTHER CORRECTIVE MEASURES IS NOT INDICATED AT THIS TIME. THE DISTRIBUTION OF THIS PRODUCT WAS CEASED MEANWHILE DUE TO BUSINESS REASONS. ZIMMER (B)(4) CONSIDERS THIS CASE AS CLOSED. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PT IS PURSUING A PRODUCT LIABILITY CLAIM ARISING OUT OF THE DUROM ACETABULAR CUP. IT WAS FURTHER REPORTED THAT THE PT RECEIVED A DUROM U.S. ACETABULAR COMPONENT 54/48 N ON (B)(6) 2009 AND EXPERIENCED PAIN AND ELEVATED COBALT ION LEVELS. A REVISION SURGERY IS IN DISCUSSION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    29982 DUROM US ACETABULAR COMPONENT 54/48 N DUROM ACETABULAR COMPONENT KWA ZIMMER GMBH 2437096

    Patients

    Seq Age Sex Outcome Treatment
    1 Other