BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN TRILOGY LINER

    MDR report key: 1211754 · Received October 24, 2008

    Report

    Report Number
    1822565-2008-00723
    Event Type
    Injury
    Date Received
    October 24, 2008
    Date of Event
    September 3, 2008
    Report Date
    September 25, 2008
    Manufacturer
    ZIMMER, INC.
    Product Code
    KWB
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    WE COULD NOT OBTAIN A COMPLETE CATALOG NUMBER; THEREFORE, A BASELINE REPORT CANNOT BE FILED. 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 RING 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 CONSTRAINING RING IS TO PROVIDE ADDED STIFFNESS TO THE POLYMER RETAINING FINGERS WHICH CAPTURE THE HEAD. THE REVISION RELATED TO A PERI-PROSTHETIC FRACTURE OF AN EXETER STEM. NO PRODUCT WAS RETURNED. REVIEW OF THE DEVICE HISTORY RECORDS WAS ALSO NOT POSSIBLE AS THE PRODUCT AND/OR LOT NUMBERS REQUIRED FOR RETRIEVAL WERE UNAVAILABLE. 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 AVAILABLE INFO, 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 TRILOGY LINER WAS EXPLANTED IN 2008, AND REPLACED WITH TLC FOR 56 MM CUP. THE 56 MM TRILOGY CUP WAS RETAINED IN THE PT. IMPLANT DATE IS UNK.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Hospitalization| R