BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TRILOGY ACETABULAR SYSTEM LONGEVITY CROSSLINKED POLYETHYLENE LINER

    MDR report key: 1241110 · Received November 21, 2008

    Report

    Report Number
    1822565-2008-00825
    Event Type
    Injury
    Date Received
    November 21, 2008
    Date of Event
    October 20, 2008
    Report Date
    October 21, 2008
    Manufacturer
    ZIMMER, INC.
    Product Code
    KWB
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    INFORMATION WAS RECEIVED FROM A DISTRIBUTOR WHO IS NOT REQUIRED TO COMPLETE FORM 3500A. EVALUATION SUMMARY - THE ALLEGED COMPLAINT REFERS TO A TRILOGY LONGEVITY LINER THAT WAS FRACTURED. THE DEVICE WAS NOT RETURNED FOR EVALUATION. THE REPORT STATED THAT THE PATIENT WAS OF A "LARGE" BUILD AND THAT THE ACETABULAR CUP WAS RETROVERTED (REQUIRING A REVISION) AND POTENTIALLY CAUSING THE PATIENT'S DISLOCATED HIP. THERE WAS NO REFERENCE TO ACTIVITY LEVEL OR WHETHER OR NOT THE DISLOCATED HIP WAS FROM A FALL OR OTHER HIGH INTENSITY IMPACTION. X-RAYS AND/OR PICTURES WERE NOT SUPPLIED FOR REVIEW SO, IT COULD NOT BE DETERMINED HOW/WHERE THE LINER FRACTURED. FINALLY, THE MATING COMPONENTS TO THE TRILOGY LONGEVITY LINER WERE NOT STATED. IT IS POSSIBLE THAT THE DEVICE WAS SUBJECTED TO OFF LABEL USE OR PAIRED WITH "UNAPPROVED" DEVICES. BASED ON THE INFORMATION PROVIDED A CAUSE CAN NOT BE DEFINITELY 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 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 HAVING A DISLOCATED HIP. THE ACETABULAR CUP WAS RETROVERTED SO IT WAS DETERMINED TO DO A REVISION. ON REMOVAL OF THE LINER IT WAS NOTICED THAT THE LINER WAS FRACTURED. POLY DEBRIS WAS REMOVED.

    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 60618251

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Hospitalization| R