BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TRILOGY ACETABULAR SYSTEM LONGEVITY CROSSLINKED POLYETHYLENE LINER

    MDR report key: 1241507 · Received November 20, 2008

    Report

    Report Number
    1822565-2008-00817
    Event Type
    Injury
    Date Received
    November 20, 2008
    Date of Event
    October 15, 2008
    Report Date
    October 16, 2008
    Manufacturer
    ZIMMER, INC.
    Product Code
    KWB
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    INFORMATION WAS RECEIVED FROM A DISTRIBUTOR WHO IS NOT REQUIRED TO COMPLETE FORM 3500A. EVALUATION SUMMARY - THE LONGEVITY HIGH CROSSLINKED POLYETHYLENE 10 DEGREE ELEVATED LINER WAS REVISED FROM A TM SHELL. THE LINER WAS IN VIVO APPROXIMATELY 4 YEARS. IT IS NOT KNOWN IF THE LINER FRACTURE TRIGGERED THE REVISION SINCE IRREGULAR WEAR PATTERNS WERE FOUND ON THE FRACTURED PIECES OF THE LINER. WHICH LED US TO BELIEVE THAT THE LINER WAS IN VIVO FOR QUITE SOME TIME AFTER THE FRACTURE. IT IS NOT KNOWN WHETHER THE FEMORAL HEAD OR STEM WERE REVISED. TITANIUM PARTICLES WERE FOUND ON THE POLY. PATIENT INFORMATION SUCH AS WEIGHT AND ACTIVITY LEVEL WERE NOT PROVIDED. X-RAYS AND SURGICAL NOTES WERE NOT PROVIDED. SEM ANALYSIS INDICATES THAT THE FRACTURE OCCURRED BY FATIGUE. EDS ANALYSIS OF THE DARK STAIN ON THE OD OF THE LINER SHOWED TI PEAK IN THE SPECTRUM THAT MAY HAVE RESULTED IN CONTACT WITH THE TM SHELL. THE EXACT CAUSE CAN NOT BE DETERMINED WITH CERTAINTY. DEVICE HISTORY RECORDS INDICATE ALL COMPONENTS WERE MANUFACTURED AND INSPECTED TO SPECIFICATION. SCANNING ELECTRONIC MICROSCOPY ANALYSIS (SEM) / ENERGY DISPERSIVE SPECTROSCOPY (EDS) ANALYSIS WAS PERFORMED.

    Description of Event or Problem · 1

    IT IS REPORTED THAT THE DEVICE WAS REVISED IN 2008. EXACT IMPLANT DATE IS UNKNOWN. DEVICE WAS IMPLANTED 4 YEARS AGO.

    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 60153617

    Patients

    Seq Age Sex Outcome Treatment
    1 80 YR Hospitalization| R