BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NEXGEN LEGACY KNEE-POSTERIOR STABILIZED FLEX ARTICULAR SURFACE

    MDR report key: 6040606 · Received October 19, 2016

    Report

    Report Number
    0001822565-2016-03744
    Event Type
    Malfunction
    Date Received
    October 19, 2016
    Date of Event
    September 14, 2016
    Report Date
    February 7, 2017
    Manufacturer
    ZIMMER, INC.
    Product Code
    JWH
    PMA / PMN Number
    PK991581
    Removal / Correction Number
    N/A
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

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

    Additional Manufacturer Narrative · 1

    THIS REPORT WILL BE AMENDED WHEN OUR INVESTIGATION IS COMPLETE.

    Additional Manufacturer Narrative · 1

    THE DEVICE WAS RETURNED WITH THE COMPLAINT FOR REVIEW. VISUAL INSPECTION OF THE RETURNED PRODUCT SHOWED THAT THE DOVETAIL FEATURE OF THE ARTICULAR SURFACE IS FLARED OUT; INDICATIVE OF THE ARTICULAR SURFACE BEING REMOVED FROM THE TIBIAL TRAY. SCUFF MARKS AND SCRATCHES INDICATIVE OF USE CAN BE SEEN AROUND THE OUTER EDGES AND ON THE DISTAL SURFACE OF THE IMPLANT. DIMENSIONAL ANALYSIS OF THE RETURNED DEVICE SHOWED RECORDED DIMENSIONS TO BE WITHIN PRINT SPECIFICATION. THE DIMENSIONS OF THE DOVETAIL COULD NOT BE VERIFIED BECAUSE OF THE FLARED CONDITION OF THE FEATURE WHEN THE PART WAS RECEIVED FOR REVIEW. THE DEVICE HISTORY RECORDS WERE REVIEWED FOR DEVIATIONS AND/OR ANOMALIES WITH NO DEVIATIONS/ANOMALIES IDENTIFIED. THE DEVICE IS USED FOR TREATMENT. A COMPLAINT HISTORY REVIEW WAS PERFORMED FOR PART # 00-5964-040-12. THE SEARCH IDENTIFIED NO (0) ADDITIONAL COMPLAINTS FOR THE SAME LOT (63017536) AND THE SAME OR SIMILAR ISSUE. THE COMPATIBILITY OF EACH COMPONENT WAS REVIEWED AND THE ARTICULAR SURFACE WAS FOUND TO BE COMPATIBLE WITH BOTH THE TIBIAL PLATE (PART # 00-5980-047-01) AND THE FEMORAL COMPONENT (PART # 00-5764-015-52) UTILIZED DURING THE SURGERY. A DEFINITIVE ROOT CAUSE CANNOT BE DETERMINED WITH THE INFORMATION PROVIDED.

    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.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE ARTICULAR SURFACE COULD NOT BE FIXATED ON THE TIBIAL PLATE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    691666 NEXGEN LEGACY KNEE-POSTERIOR STABILIZED FLEX ARTICULAR SURFACE KNEE, PROSTHESIS JWH ZIMMER, INC. N/A 63017536

    Patients

    Seq Age Sex Outcome Treatment
    1 59 YR