BEUDAMED
    FDA Adverse Event Injury Summary report: N

    POLISHED FINNED TIB TRAY 79MM

    MDR report key: 8459874 · Received March 28, 2019

    Report

    Report Number
    0009610576-2019-00007
    Event Type
    Injury
    Date Received
    March 28, 2019
    Date of Event
    December 12, 2018
    Report Date
    March 26, 2019
    Manufacturer
    BIOMET SPAIN, S.L.
    Product Code
    KRO
    PMA / PMN Number
    SEE H10
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SZ
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). CONCOMITANT MEDICAL PRODUCTS: REF. 183110; LOT J3660206; DESCRIPTION: VANGUARDTM PS INTERLOK FEMORAL 67.5MM RIGHT. REF. EP-183400; LOT 813140; DESCRIPTION: VANGUARDTM E1TM CR TIBIAL BEARING 59X10MM. REPORT SOURCE: (B)(6). PMA/510K: THIS PRODUCT IS MANUFACTURED BY BIOMET (B)(4) AND IS NOT CLEARED OR DISTRIBUTED IN THE U.S. HOWEVER, THIS REPORT IS BEING SUBMITTED AS ZIMMER BIOMET (B)(4) MANUFACTURES A SIMILAR DEVICE THAT IS CLEARED OR DISTRIBUTED IN THE UNITED STATES UNDER 510(K) NUMBER K945028. DEVICE EVALUATED BY MFR: REMAINS IMPLANTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT UNDERWENT AN INITIAL KNEE ARTHROPLASTY (B)(6) 2016. THE SURGEON NOTICED A LOOSENING OF THE TIBIAL COMPONENT ON (B)(6) 2018. THUS, THE SURGEON WILL EXCHANGE IT ON (B)(6) 2019.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    252159 POLISHED FINNED TIB TRAY 79MM PROTHESIS, KNEE KRO BIOMET SPAIN, S.L. N/A UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R