BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PERSONA TIBIAL ARTICULAR SURFACE PROVISIONAL

    MDR report key: 6156297 · Received December 8, 2016

    Report

    Report Number
    0001822565-2016-04589
    Event Type
    Malfunction
    Date Received
    December 8, 2016
    Date of Event
    November 9, 2016
    Report Date
    March 29, 2017
    Manufacturer
    ZIMMER, INC.
    Product Code
    JWH
    PMA / PMN Number
    PK113369
    Removal / Correction Number
    Z-2297-2014
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KS, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THIS FOLLOW-UP REPORT IS BEING FILED TO RELAY CORRECTED INFORMATION, WHICH WAS INCORRECT AT THE TIME OF INITIAL FOLLOW UP . COMPLAINT SAMPLE WAS EVALUATED AND THE REPORTED EVENT WAS CONFIRMED. VISUAL INSPECTION OF THE RETURNED TIBIAL ARTICULAR SURFACE PROVISIONAL (TASP) REPORTED THAT IT IS FRACTURED (ALL PCS RETURNED). DHR WAS REVIEWED AND NO DISCREPANCIES WERE FOUND. REVIEW OF THE COMPLAINT HISTORY DETERMINED THAT NO FURTHER ACTION IS REQUIRED AS NO NEW WERE TRENDS IDENTIFIED. A CAPA INVESTIGATION INTO THIS ISSUE DETERMINED THAT THE LIKELY ROOT CAUSE FOR THE TASP FRACTURES IS BENDING/TORSIONAL LOADING ON THE DEVICE. A NOTIFICATION WAS SENT TO THE FIELD ON AUGUST 7TH, 2014 TO PROVIDE ADDITIONAL CLARIFICATIONS RELATING TO THE INSTRUCTIONS FOR USE OF THE TASP CONSTRUCT FOR ALL PERSONA USERS ON FILE AT THE TIME OF THE FIELD NOTICE. PS TASP TOP COMPONENTS AND STANDARD (NON-CPS) TASP BOTTOM COMPONENTS HAVE BEEN MODIFIED TO PREVENT FRACTURE. THE FRACTURED TASP COMPONENT IN THIS COMPLAINT WAS MANUFACTURED BEFORE THE DESIGN MODIFICATION. INVESTIGATION RESULTS CONCLUDED THAT THE REPORTED EVENT WAS DUE TO A PREVIOUSLY ADDRESSED DESIGN ISSUE. IF ANY FURTHER INFORMATION IS FOUND WHICH WOULD CHANGE OR ALTER ANY CONCLUSIONS OR INFORMATION, A SUPPLEMENTAL WILL BE FILED ACCORDINGLY. ZIMMER BIOMET WILL CONTINUE TO MONITOR FOR TRENDS.

    Description of Event or Problem · 1

    IT HAS BEEN REPORTED THAT THE PROVISIONAL WAS FOUND TO BE FRACTURED. IT IS CURRENTLY UNKNOWN WHERE THE FRACTURED PIECE OF THE PROVISIONAL IS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    806599 PERSONA TIBIAL ARTICULAR SURFACE PROVISIONAL KNEE INSTRUMENT JWH ZIMMER, INC. N/A 62268818

    Patients

    Seq Age Sex Outcome Treatment
    1 Other