BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BIOMET TIBIAL LOCKING BAR

    MDR report key: 7539598 · Received May 23, 2018

    Report

    Report Number
    0001825034-2018-03532
    Event Type
    Injury
    Date Received
    May 23, 2018
    Date of Event
    December 27, 2017
    Report Date
    May 16, 2019
    Manufacturer
    ZIMMER BIOMET, INC.
    Product Code
    JWH
    PMA / PMN Number
    PK833921
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    REPORTED EVENT WAS UNABLE TO BE CONFIRMED DUE TO LIMITED INFORMATION RECEIVED FROM THE CUSTOMER. DHR WAS REVIEWED AND NO DISCREPANCIES RELEVANT TO THE REPORTED EVENT WERE FOUND. ROOT CAUSE WAS UNABLE TO BE DETERMINED AS THE NECESSARY INFORMATION TO ADEQUATELY INVESTIGATE THE REPORTED EVENT WAS NOT PROVIDED. 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). CONCOMITANT MEDICAL PRODUCTS: 148308, BMT SPLINED KNEE STM V2 18X80, 978960, 183888, VNGD SSK PSC TIB BRG 18X71/75, 933040, 148321, BMT SPLINED KNEE STM V2 18X120, 661140, 141491, OFFSET TIB TRAY 5.0MM ADAPTOR, 221940, 184204, VNGD DIST FEM AUG 65X10 LL/RM, 747090, 184184, VNGD DIST FEM AUG 65X10 RL/LM, 046490, 141763, BIOMET TIB BLOCK 10MM 71, 222670, 141491, OFFSET TIB TRAY 5.0MM ADAPTOR, 221940, 183304, VNGD SSK INTLK FMRL 65 RT, 220670. CUSTOMER HAS INDICATED THAT THE PRODUCT WILL NOT 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. MULTIPLE MDR REPORTS WERE FILED FOR THIS EVENT, PLEASE SEE ASSOCIATED REPORTS: 0001825034 - 2018 - 03531, 0001825034 - 2018 - 03530, 0001825034 - 2018 - 03533, 0001825034 - 2018 - 03534, 0001825034 - 2018 - 03535, 0001825034 - 2018 - 03536, 0001825034 - 2018 - 03537, 0001825034 - 2018 - 03538, 0001825034 - 2018 - 03539. PRODUCT LOCATION UNKNOWN.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PATIENT UNDERWENT A RIGHT KNEE PROCEDURE. SUBSEQUENTLY THE PATIENT WAS REVISED DUE TO UNKNOWN REASONS. ATTEMPTS HAVE BEEN MADE AND ADDITIONAL INFORMATION ON THE REPORTED EVENT IS UNAVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    379706 BIOMET TIBIAL LOCKING BAR PROSTHESIS, KNEE JWH ZIMMER BIOMET, INC. N/A 516520

    Patients

    Seq Age Sex Outcome Treatment
    1 68 YR Hospitalization| R