BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PERSONA TIBIAL ARTICULAR SURFACE PROVISIONAL SHIM SIZE GH 10 MM THICKNESS

    MDR report key: 6370108 · Received March 1, 2017

    Report

    Report Number
    0001822565-2017-01298
    Event Type
    Malfunction
    Date Received
    March 1, 2017
    Date of Event
    January 24, 2017
    Report Date
    April 14, 2017
    Manufacturer
    ZIMMER, INC.
    Product Code
    JWH
    PMA / PMN Number
    PK113369
    Removal / Correction Number
    SEE H10 NARRATIVE
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. RECALL NUMBERS: ZFA 2014-67 AND Z-1052-2015. COMPLAINT SAMPLE WAS EVALUATED AND THE REPORTED EVENT WAS CONFIRMED. VISUAL INSPECTION OF THE TASP SHIM SHOWS SIGNS OF REPEATED USE AND HAS ONE EACH OF COMPONENTS 1 AND 2 DISASSEMBLED AND MISSING. DHR WAS REVIEWED AND NO DISCREPANCIES WERE FOUND. REVIEW OF THE COMPLAINT HISTORY DETERMINED THAT NO FURTHER ACTION IS REQUIRED AS NO TRENDS WERE IDENTIFIED. INVESTIGATION RESULTS CONCLUDED THAT THE REPORTED EVENT WAS DUE TO DESIGN OF THE DEVICE AND WAS SUBSEQUENTLY REDESIGNED. IF ANY FURTHER INFORMATION IS FOUND WHICH WOULD CHANGE OR ALTER ANY CONCLUSIONS OR INFORMATION, A SUPPLEMENTAL WILL BE FLED ACCORDINGLY. ZIMMER BIOMET WILL CONTINUE TO MONITOR FOR TRENDS.

    Description of Event or Problem · 1

    IT IS REPORTED THAT THE DEVICE WAS MISSING THE BALL BEARING FROM THE SHIM. THERE WERE NO COMPLICATIONS OR DELAY REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    152847 PERSONA TIBIAL ARTICULAR SURFACE PROVISIONAL SHIM SIZE GH 10 MM THICKNESS PROSTHESIS, KNEE JWH ZIMMER, INC. N/A 62442834

    Patients

    Seq Age Sex Outcome Treatment
    1