BEUDAMED
    FDA Adverse Event Injury Summary report: N

    POLISHED FINNED TIB TRAY 63MM

    MDR report key: 11549772 · Received March 23, 2021

    Report

    Report Number
    0009610576-2021-00003
    Event Type
    Injury
    Date Received
    March 23, 2021
    Date of Event
    March 11, 2021
    Report Date
    June 29, 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
    PO
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(4). D10. ASSOCIATED PRODUCTS: TIBIAL BEARING REF (B)(4), LOT 082450; CR FEMORAL REF (B)(4), LOT J3813089; CEMENT REF (B)(4), LOT A727B05290. 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

    IT HAS BEEN REPORTED THAT ON (B)(6) 2019 THE PATIENT UNDERWENT A PRIMARY KNEE PROSTHESIS WITH VANGUARD. THE PATIENT STARTED WITH CONSTANT PAIN WHICH BECAME DISABLING. THE SURGEON DECIDED TO REVIEW THE TOTAL PROSTHESIS. DURING THE REVISION SURGERY ON (B)(6) 2021, A TOTAL DETACHMENT OF THE VANGUARD TIBIAL PLATE WAS DETECTED, WITHOUT ANY CEMENT RESIDUE AT THE BASE.

    Additional Manufacturer Narrative · 1

    (B)(4). ASSOCIATED PRODUCTS: TIBIAL BEARING REF 189022, LOT 082450; CR FEMORAL REF. 183022, LOT J3813089; CEMENT REF. 4720502083-1, LOT A727B05290. 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 (B)(4) MANUFACTURES A SIMILAR DEVICE THAT IS CLEARED OR DISTRIBUTED IN THE UNITED STATES UNDER 510(K) NUMBER K945028. DEVICE NOT RETURNED YET.

    Description of Event or Problem · 1

    IT HAS BEEN REPORTED THAT ON (B)(6) 2019 THE PATIENT UNDERWENT A PRIMARY KNEE PROSTHESIS WITH VANGUARD. THE PATIENT STARTED WITH CONSTANT PAIN WHICH BECAME DISABLING. THE SURGEON DECIDED TO REVIEW THE TOTAL PROSTHESIS. DURING THE REVISION SURGERY ON (B)(6) 2021, A TOTAL DETACHMENT OF THE VANGUARD TIBIAL PLATE WAS DETECTED, WITHOUT ANY CEMENT RESIDUE AT THE BASE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    447982 POLISHED FINNED TIB TRAY 63MM PROSTHESIS, KNEE KRO BIOMET SPAIN, S.L. N/A 2018080444

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention