BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BIOMET CC CRUCIATE TRAY 91MM

    MDR report key: 12445811 · Received September 9, 2021

    Report

    Report Number
    0009610576-2021-00009
    Event Type
    Injury
    Date Received
    September 9, 2021
    Date of Event
    June 23, 2021
    Report Date
    October 14, 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
    NL
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(4). D10- ASSOCIATED PRODUCTS: ITEM NAME VNGD PS OPEN POR FMRL RT 72.5 REF.#184513 LOT # 680820. ITEM NAME VNGD PS TIB BRG 12X87/91MM REF.#183682 LOT # 270850. G4: 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 WAS REPORTED THAT THE PATIENT UNDERWENT AN INITIAL SURGERY ON (B)(6) 2021. SUBSEQUENTLY, THE PATIENT UNDERWENT A REVISION DUE TO LOOSENING OF THE CEMENT-LESS FEMORAL VANGUARD PS COMPONENT 4 MONTHS AFTER IMPLANTATION. IT WAS ALSO DISCOVERED THAT THE TIBIAL COMPONENT WAS SHOWING SIGNS OF LOOSENING AND THAT THERE WERE BLACK SPOTS VISIBLE ON THE PE BEARING.

    Additional Manufacturer Narrative · 1

    (B)(4). CONCOMITANT MEDICAL PRODUCTS- ASSOCIATED PRODUCTS: ITEM NAME VNGD PS OPEN POR FMRL RT 72.5 REF.#184513 LOT # 680820. ITEM NAME VNGD PS TIB BRG 12X87/91MM REF.#183682 LOT # 270850. 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. DEVICE IN TRANSIT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT UNDERWENT AN INITIAL SURGERY ON (B)(6) 2021. SUBSEQUENTLY, THE PATIENT UNDERWENT A REVISION DUE TO LOOSENING OF THE CEMENT-LESS FEMORAL VANGUARD PS COMPONENT 4 MONTHS AFTER IMPLANTATION. IT WAS ALSO DISCOVERED THAT THE TIBIAL COMPONENT WAS SHOWING SIGNS OF LOOSENING AND THAT THERE WERE BLACK SPOTS VISIBLE ON THE PE BEARING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1344035 BIOMET CC CRUCIATE TRAY 91MM PROSTHESIS, KNEE KRO BIOMET SPAIN, S.L. N/A 2019070376

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R SEE H10| SEE H10