BEUDAMED
    FDA Adverse Event Injury Summary report: N

    POLISHED FINNED TIBIAL TRAY 71 MM

    MDR report key: 6394793 · Received March 10, 2017

    Report

    Report Number
    0009610576-2017-00010
    Event Type
    Injury
    Date Received
    March 10, 2017
    Date of Event
    February 7, 2017
    Report Date
    March 10, 2017
    Manufacturer
    BIOMET SPAIN, S.L.
    Product Code
    JWH
    PMA / PMN Number
    PSEE H10
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FI
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT PRODUCTS: VANGUARD CR LIP TIBIAL BEARING, CATALOG #: 183544, LOT #: 2009090358. VANGUARD CR FEMORAL -RT 70, CATALOG #: 183012, LOT #: UNKNOWN. (B)(4). 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 MANUFACTURES A SIMILAR DEVICE THAT IS CLEARED OR DISTRIBUTED IN THE UNITED STATES UNDER 510K NUMBER K915132. CUSTOMER HAS INDICATED THAT THE PRODUCT IS IN PROCESS OF BEING RETURNED TO ZIMMER BIOMET FOR INVESTIGATION. ONCE INVESTIGATION HAS BEEN COMPLETED, A FOLLOW-UP MDR WILL BE SUBMITTED.

    Description of Event or Problem · 1

    IT HAS BEEN REPORTED THAT 6 YEARS FOLLOWING A KNEE ARTHROPLASTY, THE PATIENT WAS REVISED DUE TO TIBIAL LOOSENING AND SUBSIDENCE. NO ADDITIONAL PATIENT CONSEQUENCES HAVE BEEN REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    178998 POLISHED FINNED TIBIAL TRAY 71 MM PROSTHESIS, KNEE JWH BIOMET SPAIN, S.L.

    Patients

    Seq Age Sex Outcome Treatment
    1 67 YR Hospitalization| R