BEUDAMED
    FDA Adverse Event Injury Summary report: N

    POLISHED FINNED TIB TRAY 83MM

    MDR report key: 8073254 · Received November 15, 2018

    Report

    Report Number
    0009610576-2018-00038
    Event Type
    Injury
    Date Received
    November 15, 2018
    Date of Event
    August 31, 2018
    Report Date
    November 14, 2018
    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
    UK
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). CONCOMITANT MEDICAL PRODUCTS: VNGD PS OPEN INTL FEM RT 70, REF. 183112, LOT J6183609. THIS PRODUCT IS MANUFACTURED BY BIOMET (B)(4) ORTHOPAEDICS, (B)(4) 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. REMAINS IMPLANTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT UNDERWENT RIGHT KNEE ARTHROPLASTY ON (B)(6) 2018. SUBSEQUENTLY, ON (B)(6) 2018, IT WAS REPORTED THAT THE PATIENT UNDERWENT KNEE REOPERATION (PROCEDURE DEBRIDEMENT).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    916104 POLISHED FINNED TIB TRAY 83MM PROTHESIS KNEE KRO BIOMET SPAIN, S.L. N/A 2018010134

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization