BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TRILOGY LONGEVITY POLY LINER

    MDR report key: 3150415 · Received March 19, 2013

    Report

    Report Number
    2648920-2013-00078
    Event Type
    Injury
    Date Received
    March 19, 2013
    Date of Event
    February 13, 2013
    Report Date
    February 19, 2013
    Manufacturer
    ZIMMER
    Product Code
    LPH
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    EVAL SUMMARY: NO PRODUCT OR PHOTOS ARE RETURNED FOR REVIEW, THEREFORE THE EXACT CONDITIONS OF THE COMPONENTS ARE UNK. NEITHER X-RAYS NOR SURGICAL NOTES WERE PROVIDED FOR REVIEW, THEREFORE THE COMPONENT FIT AND ORIENTATION PER THE SURGICAL TECHNIQUE COULD NOT BE ASSESSED. IN GENERAL, PT FACTORS THAT MAY AFFECT THE PERFORMANCE OF THE COMPONENTS INCLUDE: AGE, BONE QUALITY, HEIGHT/WEIGHT, ACTIVITY LEVEL, TYPE OF ACTIVITY (LOW IMPACT VS. HIGH IMPACT), AND RELEVANT MEDICAL HISTORY. CAUSE CANNOT BE DEFINITIVELY DETERMINED. REVIEW OF THE DEVICE HISTORY RECORDS DID NOT FIND ANY DEVIATIONS OR ANOMALIES. IT IS NOT SUSPECTED THAT THE PRODUCT FAILED TO MEET SPECS. 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 ADD'L SUBSTANTIVE INFO BE RECEIVED, THE COMPLAINT WILL BE REOPENED. ZIMMER, INC. CONSIDERS THE INVESTIGATION CLOSED.

    Description of Event or Problem · 1

    IT IS REPORTED THAT THE PT WAS REVISED DUE TO SUSPICION OF INFECTION. IT WAS NOTED THAT THE LINER HAD DISASSOCIATED FROM THE SHELL. A THIN LAYER HAD DETACHED FROM THE LINER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    115074 TRILOGY LONGEVITY POLY LINER LPH ZIMMER 60456891

    Patients

    Seq Age Sex Outcome Treatment
    1 79 YR Required Intervention VERSYS FEMORAL HEAD: CAT #00801802803,| LOT #60458506