BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PERSONA TRABECULAR METAL TIBIAL COMPONENT

    MDR report key: 3142791 · Received May 24, 2013

    Report

    Report Number
    1822565-2013-00869
    Event Type
    Malfunction
    Date Received
    May 24, 2013
    Date of Event
    April 26, 2013
    Report Date
    April 26, 2013
    Manufacturer
    ZIMMER, INC.
    Product Code
    JWH
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    EVAL SUMMARY: NO DEVICES OR PHOTOS WERE RECEIVED, THEREFORE, THE CONDITION OF THE COMPONENTS IS UNK. THE PERSONA TRABECULAR METAL SURGICAL TECHNIQUE STATES, "SLOWLY IMPACT THE TIBIAL PLATE UNTIL THE PEGS ARE APPROX HALF-WAY SEATED. PERFORM A VISUAL CHECK TO ENSURE THAT PEGS ARE STILL WELL ALIGNED TO THE HOLES PRIOR TO FULLY SEATING THE IMPLANT. ASSESS THE INITIAL STABILITY OF THE TIBIAL COMPONENT BY APPLYING MODERATE THUMB PRESSURE ON THE TIBIAL PLATE EITHER ANTERIORLY OR POSTERIORLY. IF MOVEMENT IS DETECTED, THE PERSONA TRABECULAR METAL TIBIAL TRAY SHOULD BE CEMENTED TO THE PROXIMAL TIBIA." THUS, THE EVENT DESCRIBED ABOVE IS PER THE SURGICAL TECHNIQUE AND IS INTENDED USE, IF THE PT'S BONE STOCK WAS POOR. IT IS UNK AT THIS TIME IF THE PT'S BONE STOCK WAS POOR. WITHOUT SUFFICIENT EVIDENCE, ROOT CAUSE CANNOT BE DETERMINED AT THIS TIME. EVAL - 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 AFTER THE TIBIAL IMPLANT WAS IMPACTED THE TRAY DID NOT APPEAR TO BE SECURE. BONE CEMENT WAS USED ON THE UNDERSIDE OF THE TRAY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    232811 PERSONA TRABECULAR METAL TIBIAL COMPONENT JWH ZIMMER, INC. 62186990

    Patients

    Seq Age Sex Outcome Treatment
    1 57 YR