BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TIBIAL ARTICULAR SURFACE PROVISIONAL LEFT SIZE EF

    MDR report key: 10423719 · Received August 18, 2020

    Report

    Report Number
    0001822565-2020-02954
    Event Type
    Malfunction
    Date Received
    August 18, 2020
    Date of Event
    July 29, 2020
    Report Date
    September 18, 2020
    Manufacturer
    ZIMMER BIOMET, INC.
    Product Code
    JWH
    PMA / PMN Number
    K113369
    Removal / Correction Number
    N/A
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. UPDATED: B4, D10, G4, G7, H2, H3, H6, AND H10. COMPLAINT SAMPLE WAS EVALUATED AND THE REPORTED EVENT WAS CONFIRMED. REVIEW OF RETURNED INSTRUMENT SHOWS SIGNS OF REPEATED USE (NICKED OR GOUGED) AND IS FRACTURED. DEVICE HISTORY RECORD WAS REVIEWED AND NO DISCREPANCIES RELEVANT TO THE REPORTED EVENT WERE FOUND. ROOT CAUSE WAS UNABLE TO BE DETERMINED. 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 · 0

    NO FURTHER EVENT INFORMATION AVAILABLE AT THE TIME OF THIS REPORT.

    Additional Manufacturer Narrative · 1

    (B)(4). MULTIPLE MDR REPORTS WERE FILED FOR THIS EVENT, PLEASE SEE ASSOCIATED REPORTS: 0001822565-2020-02954 AND 0001822565-2020-02955. MEDICAL DEVICES: UC TIBIAL ARTICULAR SURFACE PROVISIONAL CATALOG#: 42517200510 LOT#: 63757620. PRODUCT HAS BEEN RECEIVED BY ZIMMER BIOMET AND THE INVESTIGATION IS IN PROCESS. ONCE THE INVESTIGATION HAS BEEN COMPLETED, A FOLLOW-UP MDR WILL BE SUBMITTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT INSTRUMENT FRACTURED DURING A INITIAL PROCEDURE. ATTEMPTS HAVE BEEN MADE AND NO FURTHER INFORMATION HAS BEEN PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    883296 TIBIAL ARTICULAR SURFACE PROVISIONAL LEFT SIZE EF PROSTHESIS, KNEE JWH ZIMMER BIOMET, INC. N/A 63110362

    Patients

    Seq Age Sex Outcome Treatment
    1