BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TRILOGY SHELL SPIKED

    MDR report key: 2950051 · Received February 6, 2013

    Report

    Report Number
    2648920-2013-00039
    Event Type
    Injury
    Date Received
    February 6, 2013
    Date of Event
    December 26, 2012
    Report Date
    January 7, 2013
    Manufacturer
    ZIMMER
    Product Code
    LPH
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    EVAL SUMMARY: NEITHER OPERATIVE NOTES OR X-RAYS WERE RETURNED FOR REVIEW. IN GENERAL, PT FACTORS THAT MAY AFFECTS 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. REHABILITATION PROTOCOL AND ADHERENCE THERETO IS UNK. 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 MULTIPLE DISLOCATIONS. THE SHELL WAS NOTED TO BE IN A POOR POSITION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    50384 TRILOGY SHELL SPIKED LPH ZIMMER 61283455

    Patients

    Seq Age Sex Outcome Treatment
    1 85 YR Required Intervention VERSYS FEMORAL HEAD: CAT #00801803202,| LOT #61283357| TRILOGY LONGEVITY POLY LINER, CAT #00632005832,| LOT #61294012