BEUDAMED
    FDA Adverse Event Injury Summary report: N

    POLISHED FINNED 1 PIECE TIBIAL TRAY

    MDR report key: 6944353 · Received October 12, 2017

    Report

    Report Number
    0009610576-2017-00035
    Event Type
    Injury
    Date Received
    October 12, 2017
    Report Date
    October 12, 2017
    Manufacturer
    BIOMET SPAIN, S.L.
    Product Code
    JWH
    PMA / PMN Number
    PSEE H10
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IT
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). IMPLANT DATE - UNKNOWN DATE IN (B)(6) 2016. REPORT SOURCE, FOREIGN ¿ EVENT OCCURRED IN (B)(6). THIS PRODUCT IS MANUFACTURED BY ZIMMER BIOMET (B)(4) AND IS NOT CLEARED OR DISTRIBUTED IN THE U.S. HOWEVER, THIS REPORT IS BEING SUBMITTED AS ZIMMER BIOMET UK MANUFACTURES A SIMILAR DEVICE THAT IS CLEARED OR DISTRIBUTED IN THE UNITED STATES UNDER 510(K) NUMBER K915132. MULTIPLE MDR REPORTS WERE FILED FOR THIS EVENT, PLEASE SEE ASSOCIATED REPORTS: 0001825034-2017-07914, 0001825034-2017-07916. THE INVESTIGATION IS IN PROCESS. ONCE THE INVESTIGATION HAS BEEN COMPLETED, A FOLLOW-UP MDR WILL BE SUBMITTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT UNDERWENT A TOTAL KNEE REVISION SURGERY DUE TO INFECTION LESS THAN 1 YEAR POST IMPLANTATION. ATTEMPTS HAVE BEEN MADE AND ADDITIONAL INFORMATION ON THE REPORTED EVENT IS UNAVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    725144 POLISHED FINNED 1 PIECE TIBIAL TRAY PROSTHESIS, KNEE JWH BIOMET SPAIN, S.L. N/A 2016050230

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R