BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PSO KNEE BONE SUBSTITUTION

    MDR report key: 14186868 · Received April 22, 2022

    Report

    Report Number
    0009610576-2022-00003
    Event Type
    Injury
    Date Received
    April 22, 2022
    Report Date
    September 7, 2022
    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
    SP
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(4). CONCOMITANT MEDICAL PRODUCTS: MEDICAL PRODUCT: REF. (B)(4); LOT 2007110362; DESCRIPTION: TIBIAL REVISION COMP.72MM -L. EVENT OCCURRED IN (B)(6). THIS PRODUCT IS MANUFACTURED BY BIOMET (B)(6) ORTHOPAEDICS, (B)(6) AND IS NOT CLEARED OR DISTRIBUTED IN THE U.S. HOWEVER, THIS REPORT IS BEING SUBMITTED AS ZIMMER BIOMET (B)(6) MANUFACTURES A SIMILAR DEVICE THAT IS CLEARED OR DISTRIBUTED IN THE UNITED STATES UNDER 510(K) NUMBERS: K945028 AND K974558. THE MANUFACTURING SITE HAS CHANGED. EVENT PREVIOUSLY SUBMITTED THROUGH MEDWATCH (B)(4). REMAINS IMPLANTED.

    Additional Manufacturer Narrative · 0

    (B)(4). D10: MEDICAL PRODUCT, REF. 1521-05; LOT 2007110362; DESCRIPTION: TIBIAL REVISION COMP.72MM -L- G2: EVENT OCCURRED IN SPAIN. 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 AND K974558. THE MANUFACTURING SITE HAS CHANGED. EVENT PREVIOUSLY SUBMITTED THROUGH MEDWATCH 0001822565-2022-00788. H3 OTHER TEXT : REMAINS IMPLANTED.

    Description of Event or Problem · 0

    IT WAS REPORTED BY THE PMI GROUP THAT A PATIENT UNDERWENT A LEFT KNEE ARTHROPLASTY ON AN UNKNOWN DATE. SUBSEQUENTLY, THE PATIENT IS BEING CONSIDERED FOR A PMI PRODUCT ON (B)(6) 2022 AS HE HAS INSTABILITY BY THE FRACTURE OF THE LARGE TIBIAL INSERT W/SCREWS. MESTA TIBIAL 12 MM GRANDE C/TORNILLOS (RODILLA PSO/PSO KNEE).

    Description of Event or Problem · 0

    IT WAS REPORTED BY THE PMI GROUP THAT A PATIENT UNDERWENT A LEFT KNEE ARTHROPLASTY ON AN UNKNOWN DATE. SUBSEQUENTLY, THE PATIENT IS BEING CONSIDERED FOR A PMI PRODUCT ON (B)(6) 2022 AS HE HAS INSTABILITY BY THE FRACTURE OF THE LARGE TIBIAL INSERT W/SCREWS. MESTA TIBIAL 12 MM GRANDE C/TORNILLOS (RODILLA PSO/PSOKNEE).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1409565 PSO KNEE BONE SUBSTITUTION KNEE PROTHESIS KRO BIOMET SPAIN, S.L. N/A 006110240

    Patients

    Seq Age Sex Outcome Treatment
    1 Male Required Intervention