BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TRILOGY LONGEVITY CROSSLINKED POLY LINER

    MDR report key: 1980184 · Received February 1, 2011

    Report

    Report Number
    2648920-2011-00002
    Event Type
    Injury
    Date Received
    February 1, 2011
    Date of Event
    June 22, 2010
    Report Date
    January 6, 2011
    Manufacturer
    ZIMMER
    Product Code
    LPH
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    EVAL SUMMARY: IN THIS CASE IT APPEARS THAT THE EXTENT OF SOFT TISSUE TENSION MAY POSSIBLY HAVE BEEN A CONTRIBUTING FACTOR TO THE DISLOCATIONS. GIVEN THE INFO PROVIDED A DEFINITIVE CAUSE FOR THE EXPERIENCE OF THE DISLOCATIONS CANNOT BE DETERMINED WITH CERTAINTY. EVAL: 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 HAS EXPERIENCED DISLOCATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TRILOGY LONGEVITY CROSSLINKED POLY LINER LPH ZIMMER 61231081

    Patients

    Seq Age Sex Outcome Treatment
    1 50 YR Other VERSYS FEMORAL HEAD| MFG BY ZIMMER (B)(4)| CATALOG #00620205822, LOT #61127013| CATALOG #00801803602, LOT #61371537| TRABECULAR METAL MODULAR SHELL WITH CLUSTER HOLES