BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BIOMET TIBIAL LOCKING BAR

    MDR report key: 12704746 · Received October 27, 2021

    Report

    Report Number
    0001825034-2021-02966
    Event Type
    Injury
    Date Received
    October 27, 2021
    Date of Event
    October 1, 2021
    Report Date
    February 21, 2022
    Manufacturer
    ZIMMER BIOMET, INC.
    Product Code
    JWH
    PMA / PMN Number
    K063732
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    UPON RECEIPT OF ADDITIONAL INFORMATION, THE PATIENT RETAINED THE TRIAL POST. THE INITIAL REPORT WAS SUBMITTED IN ERROR AND SHOULD BE VOIDED.

    Description of Event or Problem · 0

    UPON RECEIPT OF ADDITIONAL INFORMATION, THE PATIENT RETAINED THE TRIAL POST. THE INITIAL REPORT WAS SUBMITTED IN ERROR AND SHOULD BE VOIDED.

    Additional Manufacturer Narrative · 1

    (B)(4). MEDICAL PRODUCT: VNGD PS+ TIB BRG 12X71/75MM CATALOG # 183742 LOT # 953060; BIOMET CC CRUCIATE TRAY 71MM CATALOG # 141233 LOT # J7030162; VAN PS OPEN INTL FEM-RT 67.5 CATALOG # 183110 LOT # J6638463; BIOMET TIBIAL LOCKING BAR CATALOG # 141205 LOT # 172490. CUSTOMER HAS INDICATED THAT THE PRODUCT WILL NOT BE RETURNED BECAUSE REQUESTED BUT NOT RETURNED BY HOSPITAL. ONCE THE INVESTIGATION HAS BEEN COMPLETED, A FOLLOW-UP MDR WILL BE SUBMITTED. MULTIPLE MDR REPORTS WERE FILLED FOR THIS EVENT: 0001825034-2021-02965. NOT RETURNED BY HOSPITAL.

    Description of Event or Problem · 1

    IT WAS REPORTED PATIENT UNDERWENT A REVISION PROCEDURE FIFTEEN DAYS POST IMPLANTATION DUE TO FOREIGN BODY IN KNEE. ATTEMPTS TO OBTAIN ADDITIONAL INFORMATION HAVE BEEN MADE; HOWEVER, NO MORE IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1603500 BIOMET TIBIAL LOCKING BAR PROSTHESIS KNEE JWH ZIMMER BIOMET, INC. N/A 478340

    Patients

    Seq Age Sex Outcome Treatment
    1 Female Hospitalization| R SEE H10 NARRATIVE