BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BIOMET TIBIAL LOCKING BAR

    MDR report key: 8645850 · Received May 28, 2019

    Report

    Report Number
    0001825034-2019-02268
    Event Type
    Injury
    Date Received
    May 28, 2019
    Date of Event
    May 3, 2019
    Report Date
    April 7, 2020
    Manufacturer
    ZIMMER BIOMET, INC.
    Product Code
    JWH
    PMA / PMN Number
    K171054
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

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

    Additional Manufacturer Narrative · 0

    THIS FOLLOW-UP IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. THE REPORTED EVENT CANNOT BE CONFIRMED. NO PRODUCT WAS RETURNED OR PICTURES PROVIDED; THEREFORE, VISUAL AND DIMENSIONAL EVALUATIONS COULD NOT BE PERFORMED. MEDICAL RECORDS WERE NOT PROVIDED. DEVICE HISTORY RECORD (DHR) REVIEW WAS UNABLE TO BE PERFORMED AS THE LOT NUMBER OF THE DEVICE INVOLVED IN THE EVENT IS UNKNOWN. A DEFINITIVE 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.

    Description of Event or Problem · 0

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

    Additional Manufacturer Narrative · 1

    (B)(4). REPORT SOURCE- (B)(4). 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 A PATIENT HAD AN INITIAL KNEE ARTHROPLASTY ON AN UNKNOWN DATE AND WAS REVISED DUE TO LOCKING BAR BACKING OUT. THERE IS NO ADDITIONAL INFORMATION AT THIS TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    438614 BIOMET TIBIAL LOCKING BAR PROSTHESIS, KNEE JWH ZIMMER BIOMET, INC. N/A NI

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R