BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TRILOGY LONGEVITY POLY LINER

    MDR report key: 2680675 · Received August 1, 2012

    Report

    Report Number
    1822565-2012-01645
    Event Type
    Injury
    Date Received
    August 1, 2012
    Report Date
    July 2, 2012
    Manufacturer
    ZIMMER, INC.
    Product Code
    LPH
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    EVALUATION SUMMARY: THE PER INDICATES THAT THERE IS A POSSIBILITY THAT THE PT MAY HAVE A SENSITIVITY TO CERTAIN METALS. ZIMMER MAKES INFO AVAILABLE IN THE PUBLIC DOMAIN RELATED TO THE COMPOSITION OF ZIMMER METAL IMPLANTS. SURGICAL NOTES WERE NOT PROVIDED. A DEFINITIVE ROOT CAUSE CANNOT BE DETERMINED WITH THE INFO PROVIDED. 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 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 DEVELOPED A RASH AFTER SURGERY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TRILOGY LONGEVITY POLY LINER LPH ZIMMER, INC. 60891115

    Patients

    Seq Age Sex Outcome Treatment
    1 Other TRILOGY SHELL WITH HOLES:| VERSYS FEMORAL STEM:| CATALOG #00784301426, LOT #60914143| MANUFACTURED BY ZIMMER (B)(4)| CATALOG #00620006220, LOT #60845689