BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TRILOGY LONGEVITY CONSTRAINED LINER

    MDR report key: 1214109 · Received October 24, 2008

    Report

    Report Number
    1822565-2008-00728
    Event Type
    Malfunction
    Date Received
    October 24, 2008
    Date of Event
    September 3, 2008
    Report Date
    September 14, 2008
    Manufacturer
    ZIMMER, INC.
    Product Code
    KWB
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    EVAL SUMMARY: THE SURGEON EXPRESSED CONCERN REGARDING MICROMOTION OF THE CONSTRAINING RING. IT IS UNCLEAR WHETHER THE MICROMOTION IS ALLEGED TO OCCUR BETWEEN THE POLY LINER AND CONSTRAINING LINER OR POLY LINER AND LOCKING RING SINCE PARTS WERE NOT RETURNED. HOWEVER, IF THE MICROMOTION WAS ALLEGED TO OCCUR WITH THE CONSTRAINING RING, THERE SHOULD NOT BE ANY COMPLICATIONS AND THE DEVICE IS WORKING AS INTENDED. THE CONSTRAINING RING DOES NOT EXPERIENCE ANY TENSILE OR COMPRESSIVE LOADING (WHICH WOULD CAUSE THIS TYPE OF MOTION) ONCE IMPLANTED. THE PRIMARY PURPOSE OF THE CONSTRAINED RING IS TO PROVIDE ADDED STIFFNESS TO THE POLYMER RETAINING FINGERS WHICH CAPTURE THE HEAD. EVAL: NO PRODUCT WAS RETURNED. 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 A REVISION SURGERY TOOK PLACE IN 2008, DUE TO A 56 MM TLC WHICH WAS PLACED IN A WELL FIXED 56 MM TRILOGY SHELL HAVING MICRO MOTION (APPROXIMATELY 1MM) OF LOCKING RING WHEN PUSHED UPON WITH ELEVATOR AFTER THE LOCKING RING WAS ENGAGED. NO MOTION OR POLY WAS REPORTED. MOTION WAS "UP AND DOWN" NOT ROTATIONAL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TRILOGY LONGEVITY CONSTRAINED LINER HIP PROSTHESIS KWB ZIMMER, INC. NA 6088385

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK