BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TRILOGY ACETABULAR SYSTEM LONGEVITY CROSSLINKED POLYETHLENE LINER

    MDR report key: 1405926 · Received June 19, 2009

    Report

    Report Number
    1822565-2009-00668
    Event Type
    Injury
    Date Received
    June 19, 2009
    Date of Event
    March 19, 2009
    Report Date
    May 19, 2009
    Manufacturer
    ZIMMER, INC.
    Product Code
    KWB
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE FEMORAL HEAD (MANUFACTURED BY NTK/NGK) AND TRILOGY LONGEVITY LINER WERE EXCHANGED DURING THE REVISION SURGERY, DUE TO THE PATIENT HAVING RECURRENT DISLOCATIONS. ALL OTHER COMPONENTS REMAIN IN THE PATIENT. THE PATIENT'S WEIGHT, HEIGHT, AND ACTIVITY LEVEL ARE UNKNOWN. OPERATIVE NOTES AND X-RAYS WERE NOT PROVIDED FOR REVIEW. NO INFORMATION IS INCLUDED FROM THE SURGERY REGARDING TISSUE TENSION, POTENTIAL SOURCES OF IMPINGEMENT DISPOSING THE PATIENT TO DISLOCATION, PRESENCE OR ABSENCE OF TROCHANTERIC NONUNION, OR ORIENTATION OF COMPONENTS. BASED ON THE AVAILABLE INFORMATION, A DEFINITIVE CAUSE CAN 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 2003, AND REVISED IN 2009, DUE TO RECURRENT DISLOCATION.

    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 53749500

    Patients

    Seq Age Sex Outcome Treatment
    1 74 YR Hospitalization| R