BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN TIBIAL TRAY

    MDR report key: 8824018 · Received July 24, 2019

    Report

    Report Number
    0001825034-2019-03209
    Event Type
    Injury
    Date Received
    July 24, 2019
    Date of Event
    July 9, 2019
    Report Date
    July 24, 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
    GM
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). REPORT SOURCE: FOREIGN COUNTRY: (B)(6). CONCOMITANT MEDICAL PRODUCTS: 141620 971590 BMT SPLINED KNEE STM 20X80; UNKNOWN TIBIAL BEARING. CUSTOMER HAS INDICATED THAT THE PRODUCT WILL NOT BE RETURNED TO ZIMMER BIOMET FOR INVESTIGATION, DUE TO THE LOCATION OF THE DEVICE IS UNKNOWN. 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 - 2019 - 03208.

    Description of Event or Problem · 1

    IT WAS REPORTED PATIENT¿S KNEE WAS REVISED DUE TO DISASSOCIATION OF THE FEMORAL COMPONENT FROM THE TIBIAL TRAY. DURING EXPLANATION IT WAS DIFFICULT TO REMOVE THE PRODUCT DUE TO MISSING EXPLANATION INSTRUMENTS. PARTIAL DESTRUCTION OF THE PROXIMAL TIBIA FOR EXPLANATION. ATTEMPTS HAVE BEEN MADE AND ADDITIONAL INFORMATION ON THE REPORTED EVENT IS UNAVAILABLE AT THIS TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    618133 UNKNOWN TIBIAL TRAY PROSTHESIS, KNEE JWH ZIMMER BIOMET, INC. N/A NI

    Patients

    Seq Age Sex Outcome Treatment
    1 68 YR Hospitalization| R