BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TNBN POL COCR FIN TIB TRAY 71 RAY 71 MM

    MDR report key: 14050931 · Received April 8, 2022

    Report

    Report Number
    0009610576-2022-00002
    Event Type
    Injury
    Date Received
    April 8, 2022
    Date of Event
    November 3, 2021
    Report Date
    April 8, 2022
    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
    GM
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(4). ASSOCIATED PRODUCTS: ITEM 183028TNBN LOT UNK TINBN VG INT CR ANAT FM L 65M; ITEM 183440 LOT UNK VNGD CR TIB BRG 10X71/75; EVENT OCCURED AT (B)(6). THIS PRODUCT IS MANUFACTURED BY BIOMET SAPIN 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 510K NUMBER K945028. DISCARDED BY HOSPITAL.

    Description of Event or Problem · 0

    ASYMMETRIC POLYETHYLENE WEAR KNOWN SINCE 2019, REVISED IN 2021. PATIENT WAS REVISED. THERE WAS ALSO SUSPECTED TIBIAL LOOSENING, BUT SURGEON DID NOT CONFIRM THE SUSPICION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    186948 TNBN POL COCR FIN TIB TRAY 71 RAY 71 MM KNEE PROSTHESIS KRO BIOMET SPAIN, S.L. N/A 2011101111

    Patients

    Seq Age Sex Outcome Treatment
    1 70 YR Female Required Intervention