BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BMT TIB TRAY 67MM

    MDR report key: 12631993 · Received October 14, 2021

    Report

    Report Number
    0001825034-2021-02835
    Event Type
    Injury
    Date Received
    October 14, 2021
    Date of Event
    September 21, 2021
    Report Date
    November 19, 2021
    Manufacturer
    ZIMMER BIOMET, INC.
    Product Code
    JWH
    UDI-DI
    00880304481411
    PMA / PMN Number
    K093293
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. REPORTED EVENT WAS UNABLE TO BE CONFIRMED DUE TO LIMITED INFORMATION RECEIVED FROM THE CUSTOMER. DEVICE WAS NOT RETURNED. DEVICE HISTORY RECORD (DHR) WAS REVIEWED AND NO DISCREPANCIES RELEVANT TO THE REPORTED EVENT WERE FOUND. 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.

    Additional Manufacturer Narrative · 1

    (B)(4). MEDICAL PRODUCT: BMT SPLINED KNEE STM V2 12X80 CATALOG # 148302 LOT # 178900; BMT 360 TIB AUG 67X5MM CATALOG # 185222 LOT # 346460; BMT 360 TIB AUG 67X5MM CATALOG # 185222 LOT # 923680; PALACOS FAST R+G 1X40 CATALOG # 66056768 LOT # 95434925; BMT 360 TIB SM CRUCIATE WING CATALOG # 185650 LOT # 588160; VNGD PS TIB BRG 10X63/67MM CATALOG # 183620 LOT # 927140. REPORT SOURCE: (B)(6). 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. NOT RETURNED BY HOSPITAL.

    Description of Event or Problem · 1

    IT WAS REPORTED PATIENT UNDERWENT A REVISION PROCEDURE ONE YEAR POST IMPLANTATION DUE TO TIBIAL LOOSENING AND SUBSIDENCE. ATTEMPTS TO OBTAIN ADDITIONAL INFORMATION HAVE BEEN MADE; HOWEVER, NO MORE IS AVAILABLE AT THIS TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1528269 BMT TIB TRAY 67MM PROSTHESIS KNEE JWH ZIMMER BIOMET, INC. N/A 796960 00880304481411

    Patients

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