BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PERSONA POSTERIOR STABILIZED TIBIAL ARTICULAR SURFACE PROVISIONAL

    MDR report key: 6094484 · Received November 10, 2016

    Report

    Report Number
    0001822565-2016-04053
    Event Type
    Malfunction
    Date Received
    November 10, 2016
    Date of Event
    October 25, 2016
    Report Date
    March 31, 2017
    Manufacturer
    ZIMMER, INC.
    Product Code
    JWH
    PMA / PMN Number
    PK113369
    Removal / Correction Number
    Z-2579-2014
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THIS FOLLOW-UP REPORT IS BEING FILED TO RELAY ADDITIONAL INFORMATION, WHICH WAS UNKNOWN AT THE TIME OF THE INITIAL MEDWATCH. VISUAL INSPECTION OF THE RETURNED TIBIAL ARTICULAR SURFACE PROVISIONAL (TASP) HAS FRACTURED ON THE MEDIAL SIDE OF THE POST. THE COMPLAINT IS CONSIDERED CONFIRMED AS THE RETURNED TASP WAS FRACTURED. THE LIKELY CONDITION OF THE PART WHEN IT LEFT ZIMMER BIOMET CONTROL IS CONSIDERED CONFORMING BASED ON THE PRODUCT'S FIELD AGE AND THE DHR REVIEW. THIS DEVICE IS USED FOR TREATMENT. PREVIOUS INVESTIGATION INTO THIS ISSUE DETERMINED THAT THE LIKELY ROOT CAUSE FOR THE TASP FRACTURES IS BENDING/TORSIONAL LOADING ON THE DEVICE. 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. THE ROOT CAUSE IS CONSIDERED TO BE 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.

    Additional Manufacturer Narrative · 1

    THIS REPORT WILL BE AMENDED WHEN OUR INVESTIGATION IS COMPLETE. RETURNED, NOT YET EVALUATED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE TIBIAL ARTICULAR SURFACE PROVISIONAL FRACTURED DURING INSERTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    743197 PERSONA POSTERIOR STABILIZED TIBIAL ARTICULAR SURFACE PROVISIONAL KNEE, INSTRUMENT JWH ZIMMER, INC. N/A 62314722

    Patients

    Seq Age Sex Outcome Treatment
    1 63 YR