BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN OSS TIBIAL BUSHING

    MDR report key: 9098331 · Received September 20, 2019

    Report

    Report Number
    0001825034-2019-04189
    Event Type
    Injury
    Date Received
    September 20, 2019
    Date of Event
    November 5, 2018
    Report Date
    September 20, 2019
    Manufacturer
    ZIMMER BIOMET, INC.
    Product Code
    JWH
    PMA / PMN Number
    N/A
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BE
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    ZIMMER BIOMET COMPLAINT NUMBER (B)(4). CONCOMITANT MEDICAL PRODUCTS: OSS TIBIAL POLY BEARING 16MM; P/N: 150412, L/N: 369490; KNEE-OSS-FEMORAL BUSHINGS-UNK; P/N: UNK, L/N: UNK; KNEE-OSS-TIBIAL BUSHINGS-UNK; P/N: UNK, L/N: UNK; KNEE-OSS-LOCKING PIN-UNK; P/N: UNK, L/N: UNK; KNE-OSS-FEMORALS-UNK; P/N: UNK, L/N: UNK; KNE-OSS-TIBIAL TRAYS-UNK; P/N: UNK, L/N: UNK; OSS AUGMENT IMPACTOR; P/N: 110018814, L/N: UNK. REPORT SOURCE: FOREIGN: (B)(6). COMPLAINT SAMPLE WAS EVALUATED AND THE REPORTED EVENT WAS NOT CONFIRMED. X-RAY REVIEW BY MMI STATES THAT SUBTLE HARDWARE ABNORMALITIES CANNOT BE CLEARLY EVALUATED. NO GROSS FRACTURE OR DISPLACEMENT IDENTIFIED. SCARRING OF THE TIBIAL PLATEAU AS IDENTIFIED CLINICALLY IS NOT CONFIRMED RADIOGRAPHICALLY. DEVICE HISTORY RECORD (DHR) REVIEW WAS UNABLE TO BE PERFORMED AS THE LOT NUMBER OF THE DEVICE INVOLVED IN THE EVENT IS UNKNOWN. 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. MULTIPLE MDR REPORTS WERE FILED FOR THIS EVENT, PLEASE SEE ASSOCIATED REPORTS: 0001825034-2018-11031-2; 0001825034-2019-04188; 0001825034-2019-04189; 0001825034 -2019-04190. PRODUCT LOCATION IS UNKNOWN.

    Description of Event or Problem · 1

    IT WAS REPORTED THE PATIENT HAD A REVISION PROCEDURE 8 YEARS POST-IMPLANTATION DUE TO A TENDON/PATELLA ISSUE. DURING THE PROCEDURE, IT WAS NOTED THAT THE TIBIAL BEARING WAS PREVIOUSLY DAMAGED. SUBSEQUENTLY, THE LOCKING PIN, BUSHINGS AND TIBIAL BEARING WERE REMOVED AND REPLACED. NO ADDITIONAL PATIENT CONSEQUENCES WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    891296 UNKNOWN OSS TIBIAL BUSHING PROSTHESIS, KNEE JWH ZIMMER BIOMET, INC. N/A NI

    Patients

    Seq Age Sex Outcome Treatment
    1 28 YR Hospitalization| R