BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TRILOGY ACETABULAR SYSTEM LONGEVITY CROSSLINKED POLYETHLENE LINER

    MDR report key: 1241111 · Received November 21, 2008

    Report

    Report Number
    1822565-2008-00822
    Event Type
    Injury
    Date Received
    November 21, 2008
    Date of Event
    October 21, 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
    MD, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    EVALUATION SUMMARY - THE ALLEGED COMPLAINT REFERS TO A DAMAGED LINER. THE LINER WAS DAMAGED BY A COMPETITOR ZIRCONIUM HEAD THAT BROKE INTO PIECES AFTER 9 YEARS IMPLANTATION. THE LINER WAS NOT RETURNED FOR EVALUATION. ADDITIONALLY, THE LOT NUMBER AND/OR PHOTOGRAPHS WERE NOT SUPPLIED FOR REVIEW. CAUSE CAN NOT BE DETERMINED WITH CERTAINTY. NO PRODUCT WAS RETURNED. REVIEW OF THE DEVICE HISTORY RECORDS WAS ALSO NOT POSSIBLE AS THE PRODUCT AND/OR LOT NUMBERS REQUIRED FOR RETRIEVAL WERE UNAVAILABLE. 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 AVAILABLE INFORMATION, 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 1999, AND EXPLANTED IN 2008, DUE TO COMPETITOR ZIRCONIA HEAD AND DAMAGING LINER.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 61 YR Hospitalization| R