BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TRILOGY ALTERNATE BEARING SHELL INSERT

    MDR report key: 2020412 · Received February 8, 2011

    Report

    Report Number
    1822565-2011-00203
    Event Type
    Malfunction
    Date Received
    February 8, 2011
    Date of Event
    December 14, 2010
    Report Date
    January 12, 2011
    Manufacturer
    ZIMMER INC
    Product Code
    MRA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, 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: SINCE THE DEVICE WAS NOT RETURNED, NO ANALYSIS WAS POSSIBLE. NO INFORMATION WAS PROVIDED ON THE SHELL INTO WHICH ASSEMBLY OF THE LINER WAS ATTEMPTED. IT IS UNK IF THE SURGICAL TECHNIQUE WAS FOLLOWED WHICH STATES "WARNING: IF THE CERAMIC INSERT IS NOT UNIFORMLY SEATED BEFORE IMPACTION, THE INSERT EDGE MAY FRACTURE WHEN IMPACTED". GIVEN THE INFORMATION PROVIDED, A DEFINITIVE CAUSE FOR THE EXPERIENCE OF LINER FRACTURE CANNOT BE DETERMINED WITH CERTAINTY. EVALUATION: 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 INFORMATION BE RECEIVED, THE COMPLAINT WILL BE REOPENED. ZIMMER, INC. CONSIDERS THE INVESTIGATION CLOSED.

    Description of Event or Problem · 1

    IT IS REPORTED THAT THE LINER CRACKED AS IT WAS BEING IMPLANTED INTO THE CUP. ANOTHER LINER WAS IMPLANTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TRILOGY ALTERNATE BEARING SHELL INSERT MRA ZIMMER INC 61527521

    Patients

    Seq Age Sex Outcome Treatment
    1 42 YR