BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TRILOGY ACETABULAR SYSTEM LONGEVITY CROSSLINKED POLYETHYLENE LINER

    MDR report key: 1252423 · Received December 3, 2008

    Report

    Report Number
    1822565-2008-00868
    Event Type
    Injury
    Date Received
    December 3, 2008
    Date of Event
    October 22, 2008
    Report Date
    October 26, 2008
    Manufacturer
    ZIMMER, INC.
    Product Code
    KWB
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    EVALUATION SUMMARY: THE TRILOGY LONGEVITY XLPE LINER AND VERSYS FEMORAL HEAD WERE REVISED DUE TO ALLEGED DISLOCATION. PRODUCT AND X-RAYS WERE NOT RETURNED FOR EVALUATION. THE ORIENTATION OF THE SHELL, DIRECTION OF DISLOCATION, OR HOW THE LINER WAS SEATED IN THE SHELL COULD NOT BE DETERMINED SINCE SURGICAL NOTES WERE NOT PROVIDED. MOST LIKELY, A FALL OR TRAUMA HORIZONTALLY LOADED THE VERSYS WHICH CAUSED DISLOCATION. HOWEVER, THE EXACT CAUSE OF THE ALLEGED EVENT COULD NOT BE DETERMINED WITH CERTAINTY. NO PRODUCT WAS RETURNED. REVIEW OF THE DEVICE HISTORY RECORDS DID NOT FIND ANY DEVIATIONS OR ANOMALIES. IT IS NOT SUSPECTED THAT THE PRODUCT FAILED TO MEET SPECIFICATIONS. THE INVESTIGATION COULD NOT VERIFY OR IDENTIFY ANY EVIDENCE OF PRODUCT CONTRIBUTION TO THE REPORTED PROBLEM. BASED ON THE INVESTIGATION, THE NEED FOR CORRECTIVE ACTION IS NOT INDICATED. SHOULD ADDITIONAL SUBSTANTIVE INFORMATION BE RECEIVED, THE COMPLAINT WILL BE REOPENED. ZIMMER, INC. CONSIDERS THE INVESTIGATION CLOSED.

    Description of Event or Problem · 1

    IT IS REPORTED THAT THE DEVICE WAS IMPLANTED IN 2007, AND WAS EXPLANTED IN 2008 DUE TO THE PATIENT CONTINUING TO DISLOCATE HIS HIP.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TRILOGY ACETABULAR SYSTEM LONGEVITY CROSSLINKED POLYETHYLENE LINER HIP PROSTHESIS KWB ZIMMER, INC. NA 60379876

    Patients

    Seq Age Sex Outcome Treatment
    1 73 YR Hospitalization| R