BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CONSTRAINED TIBIAL ARTICULAR SURFACE PROVISIONAL RIGHT

    MDR report key: 7786295 · Received August 15, 2018

    Report

    Report Number
    0001822565-2018-04029
    Event Type
    Malfunction
    Date Received
    August 15, 2018
    Date of Event
    June 27, 2018
    Report Date
    November 28, 2018
    Manufacturer
    ZIMMER BIOMET, INC.
    Product Code
    MBH
    PMA / PMN Number
    K123459
    Removal / Correction Number
    N/A
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WI, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). 0001822565 - 2018 - 04030. INVESTIGATION IS IN PROGRESS. 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.

    Additional Manufacturer Narrative · 1

    (B)(4). THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. MULTIPLE MDR REPORTS WERE FILED FOR THIS EVENT, PLEASE SEE ASSOCIATED REPORTS: 0001822565-2018-04029-1 0001822565-2018-04030-1. COMPLAINT SAMPLE WAS EVALUATED AND THE REPORTED EVENT WAS CONFIRMED. 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 WAS IMPLEMENTED. DHR WAS REVIEWED AND NO DISCREPANCIES WERE FOUND. A PREVIOUSLY ADDRESSED DESIGN ISSUE IS CONSIDERED AS THE ROOT CAUSE. 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 WAS REPORTED THAT TIBIAL ARTICULAR SURFACE PROVISIONAL WAS FRACTURED. NO PATIENT INVOLVEMENT WAS REPORTED.

    Description of Event or Problem · 1

    NO NEW ADDITIONAL INFORMATION IS RECEIVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    626660 CONSTRAINED TIBIAL ARTICULAR SURFACE PROVISIONAL RIGHT PROSTHESIS, KNEE MBH ZIMMER BIOMET, INC. N/A 62432150

    Patients

    Seq Age Sex Outcome Treatment
    1