BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UNKNOWN ZIMMER TRILOGY LONGEVITY CONSTRAINED LINER

    MDR report key: 1070984 · Received July 3, 2008

    Report

    Report Number
    1822565-2008-00387
    Event Type
    Malfunction
    Date Received
    July 3, 2008
    Report Date
    June 4, 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

    WE COULD NOT OBTAIN A COMPLETE CATALOG NUMBER; THEREFORE, A BASELINE REPORT CANNOT BE FILED. EVAL SUMMARY: DEVICE WAS IN-VIVO FOR AN UNK PERIOD OF TIME. DEVICE AND X-RAYS, PT INFO SUCH AS WEIGHT, ACTIVITY LEVEL AND BUILD ARE NOT AVAILABLE. DEVICE IS NOT AVAILABLE TO ASSESS THE DIMENSIONAL SPECS. ITEM NUMBER AND LOT NUMBER ARE NOT AVAILABLE TO REVIEW DEVICE HISTORY. SURGEON NOTES ON TECHNIQUE ADOPTED ARE NOT AVAILABLE. NO ENGINEERING ANALYSIS COULD BE DONE WITH AVAILABLE INFO. EVAL: 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 CONSIDERS THE INVESTIGATION CLOSED.

    Description of Event or Problem · 1

    IT IS REPORTED THAT THE TRILOGY LONGEVITY CONSTRAINED LINER HAS DISLOCATED. EXACT OCCURRENCE AND IMPLANT DATES ARE NOT KNOWN.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK