BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OXFORD PARTIAL KNEE SYSTEM SIZE AA WITH SLOTS LEFT MEDIAL TIBIAL TRAY

    MDR report key: 6195559 · Received December 21, 2016

    Report

    Report Number
    3002806535-2016-00918
    Event Type
    Injury
    Date Received
    December 21, 2016
    Date of Event
    November 11, 2016
    Report Date
    December 21, 2016
    Manufacturer
    BIOMET UK LTD.
    Product Code
    NRA
    PMA / PMN Number
    PN/A
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MD, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    UDI# (B)(4). CONCOMITANT PRODUCT(S): - OXFORD MENISCAL BEARING CATALOG 159540 LOT 080790; OXFORD FEMUR CATALOG 161473 LOT R2498205A. THIS PRODUCT IS MANUFACTURED BY ZIMMER BIOMET (B)(4) AND IS NOT CLEARED OR DISTRIBUTED IN THE U.S. HOWEVER, THIS REPORT IS BEING SUBMITTED AS ZIMMER BIOMET IN (B)(4) MANUFACTURES A SIMILAR DEVICE IN THE UNITED STATES UNDER 510K NUMBER P010014.

    Description of Event or Problem · 1

    A PATIENT ENROLLED IN A CLINICAL STUDY EXPERIENCED A FRACTURE OF THE TIBIA BELOW THE TIBIAL TRAY. THIS WAS TREATED WITH BRACING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    842412 OXFORD PARTIAL KNEE SYSTEM SIZE AA WITH SLOTS LEFT MEDIAL TIBIAL TRAY PROSTHESIS, KNEE NRA BIOMET UK LTD. N/A R3050444A

    Patients

    Seq Age Sex Outcome Treatment
    1 70 YR Required Intervention