BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TRILOGY ACETABULAR SYSTEM LINER STANDARD LONGEVITY CROSSLINKED POLYETHELNE

    MDR report key: 1081683 · Received July 24, 2008

    Report

    Report Number
    1822565-2008-00441
    Event Type
    Injury
    Date Received
    July 24, 2008
    Date of Event
    June 12, 2008
    Report Date
    July 11, 2008
    Manufacturer
    ZIMMER, INC.
    Product Code
    KWB
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OK, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    EVALUATION SUMMARY: THE MANUFACTURED LOT MET THE STERILITY ASSURANCE REQUIREMENTS OF 10-6 OR BETTER AND IT IS UNLIKELY THAT THE SPECIFIED DEVICE CONTRIBUTED TO THE PT'S INFECTION. CAUSE CANNOT BE DEFINITIVELY DETERMINED. 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 INFO BE REC'D, THE COMPLAINT WILL BE REOPENED. ZIMMER CONSIDERS THE INVESTIGATION CLOSED.

    Description of Event or Problem · 1

    IT IS REPORTED THAT THE PT WAS ADMITTED FOR REVISION OF RIGHT TOTAL HIP, SECONDARY TO PAIN AND INFECTION WITH MRSA.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TRILOGY ACETABULAR SYSTEM LINER STANDARD LONGEVITY CROSSLINKED POLYETHELNE HIP PROSTHESIS KWB ZIMMER, INC. NA 60687241

    Patients

    Seq Age Sex Outcome Treatment
    1 65 YR Hospitalization| R