BEUDAMED
    FDA Adverse Event Injury Summary report: N

    POLISHED FINNED TIB TRAY 67MM

    MDR report key: 12007238 · Received June 16, 2021

    Report

    Report Number
    0009610576-2021-00004
    Event Type
    Injury
    Date Received
    June 16, 2021
    Date of Event
    June 2, 2021
    Report Date
    September 9, 2021
    Manufacturer
    BIOMET SPAIN, S.L.
    Product Code
    KRO
    PMA / PMN Number
    SEE H10
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BE
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(4). G5: THIS PRODUCT IS MANUFACTURED BY BIOMET SPAIN ORTHOPAEDICS, S.L. AND IS NOT CLEARED OR DISTRIBUTED IN THE U.S. HOWEVER, THIS REPORT IS BEING SUBMITTED AS ZIMMER BIOMET WARSAW MANUFACTURES A SIMILAR DEVICE THAT IS CLEARED OR DISTRIBUTED IN THE UNITED STATES UNDER 510(K) NUMBER K945028.

    Description of Event or Problem · 0

    ON (B)(6) 2021, THE PATIENT HAD A REVISION OF A VANGUARD TIBIAL KNEE IMPLANT. THERE WAS NO CEMENT BONDING ON THE TIBIAL PLATEAU OF THE PRIMARY VANGUARD. A REVISION OF A VANGUARD TIBIAL KNEE IMPLANT. THERE WAS NO CEMENT BONDING ON THE TIBIAL PLATEAU OF THE PRIMARY VANGUARD. NO ADDITIONAL INFORMATION.

    Additional Manufacturer Narrative · 1

    (B)(4). THIS PRODUCT IS MANUFACTURED BY BIOMET (B)(4) ORTHOPAEDICS, S.L. AND IS NOT CLEARED OR DISTRIBUTED IN THE U.S. HOWEVER, THIS REPORT IS BEING SUBMITTED AS ZIMMER BIOMET WARSAW MANUFACTURES A SIMILAR DEVICE THAT IS CLEARED OR DISTRIBUTED IN THE UNITED STATES UNDER 510(K) NUMBER K945028. PRODUCT LOCATION UNKNOWNS.

    Description of Event or Problem · 1

    ON (B)(6) 2021, THE PATIENT HAD A REVISION OF A VANGUARD TIBIAL KNEE IMPLANT. THERE WAS NO CEMENT BONDING ON THE TIBIAL PLATEAU OF THE PRIMARY VANGUARD. A REVISION OF A VANGUARD TIBIAL KNEE IMPLANT. THERE WAS NO CEMENT BONDING ON THE TIBIAL PLATEAU OF THE PRIMARY VANGUARD. NO ADDITIONAL INFORMATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    909318 POLISHED FINNED TIB TRAY 67MM PROSTHESIS, KNEE KRO BIOMET SPAIN, S.L. N/A 2012070081

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R