BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BMT 360 2.5MM OFFSET ADAPTER

    MDR report key: 8052745 · Received November 8, 2018

    Report

    Report Number
    0001825034-2018-10283
    Event Type
    Malfunction
    Date Received
    November 8, 2018
    Date of Event
    November 1, 2018
    Report Date
    August 29, 2019
    Manufacturer
    ZIMMER BIOMET, INC.
    Product Code
    JWH
    PMA / PMN Number
    K093293
    Removal / Correction Number
    N/A
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AR, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    THIS FOLLOW-UP IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. THE COMPLAINT IS CONSIDERED CONFIRMED AS VISUAL INSPECTION OF THE SET SCREW SHOWS THE INSIDE OF THE HEX HAS BEEN ROUNDED OFF. THE TIBIAL TRAY, CRUCIATE WING, OFFSET ADAPTOR AND SET SCREW ARE STILL ASSEMBLED. DEVICE HISTORY RECORD (DHR) WAS REVIEWED FOR DEVIATIONS AND/ OR ANOMALIES WITH NO RELEVANT DEVIATIONS / ANOMALIES IDENTIFIED. ROOT CAUSE CANNOT 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). ADDITIONAL CONCOMITANT MEDICAL PRODUCTS: BMT 360 TIB TRAY 75MM, ITEM# 185204, LOT# 182190; BMT 360 TIB SM CRUCIATE WING, ITEM# 185650, LOT# 433600. CUSTOMER HAS INDICATED THAT THE PRODUCT WILL BE RETURNED TO ZIMMER BIOMET FOR INVESTIGATION. 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 THE OFFSET AND SMALL WING WAS ALREADY ENGAGED ON THE 75 PLATE AND COULD NOT BE DISENGAGED. NO ADDITIONAL INFORMATION IS AVAILABLE AT THIS TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    892787 BMT 360 2.5MM OFFSET ADAPTER PROSTHESIS, KNEE JWH ZIMMER BIOMET, INC. N/A 711920

    Patients

    Seq Age Sex Outcome Treatment
    1