BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TIBIAL ARTICULAR SURFACE PROVISIONAL

    MDR report key: 8436147 · Received March 20, 2019

    Report

    Report Number
    0001822565-2019-01058
    Event Type
    Malfunction
    Date Received
    March 20, 2019
    Report Date
    May 15, 2019
    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
    NM, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    COMPLAINT SAMPLE WAS EVALUATED AND THE REPORTED EVENT WAS CONFIRMED. VISUAL EXAMINATION OF THE RETURNED PARTS EXHIBITS SIGNS OF REPEATED USE (NICKED OR GOUGED) AND HAS BOTH OF COMPONENTS 1 AND 2 DISASSEMBLED / MISSING. THE MISSING COMPONENTS WERE NOT RETURNED. DHR 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. MULTIPLE MDR REPORTS WERE FILED FOR THIS EVENT, PLEASE SEE ASSOCIATED REPORTS: 0001822565 - 2019 - 01057 - 1 .

    Description of Event or Problem · 0

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

    Additional Manufacturer Narrative · 1

    (B)(4). CONCOMITANT MEDICAL PRODUCTS: TIBIAL ARTICULAR SURFACE PROVISIONAL; P/N: 42527900304, L/N: 63445079. TIBIAL ARTICULAR SURFACE PROVISIONAL; P/N: 42527900502, L/N: 63440681. 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. MULTIPLE MDR REPORTS WERE FILED FOR THIS EVENT, PLEASE SEE ASSOCIATED REPORTS: 0001822565 - 2019 - 01057.

    Description of Event or Problem · 1

    IT WAS REPORTED THE MISSING BALL BEARINGS WERE NOTICED AFTER THE TRAYS WERE RE-PROCESSED. THERE WAS NO PATIENT INVOLVEMENT. ATTEMPTS TO OBTAIN ADDITIONAL INFORMATION HAVE BEEN MADE; HOWEVER, NO MORE IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    228887 TIBIAL ARTICULAR SURFACE PROVISIONAL PROSTHESIS, KNEE JWH ZIMMER BIOMET, INC. N/A 63440681

    Patients

    Seq Age Sex Outcome Treatment
    1