BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PS TIBIAL ARTICULAR SURFACE PROVISIONAL LEFT SIZE 6-9 GH TOP

    MDR report key: 7785285 · Received August 15, 2018

    Report

    Report Number
    0001822565-2018-04030
    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
    JWH
    PMA / PMN Number
    PK113369
    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). UNIQUE IDENTIFIER (UDI) #: N/A. THE 0001822565 - 2018 - 04029. 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

    CMP-(B)(4) THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. THE FOLLOWING SECTIONS WERE UPDATED: 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 REGARDING THE EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    627263 PS TIBIAL ARTICULAR SURFACE PROVISIONAL LEFT SIZE 6-9 GH TOP PROSTHESIS, KNEE JWH ZIMMER BIOMET, INC. N/A 62601570

    Patients

    Seq Age Sex Outcome Treatment
    1