BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OXFORD PARTIAL KNEE SYSTEM SIZE B HYDROXYAPATITE COATED LEFT MEDIAL TIBIAL TRAY

    MDR report key: 6191369 · Received December 20, 2016

    Report

    Report Number
    3002806535-2016-00911
    Event Type
    Injury
    Date Received
    December 20, 2016
    Date of Event
    November 4, 2016
    Report Date
    May 3, 2017
    Manufacturer
    BIOMET UK LTD.
    Product Code
    NRA
    PMA / PMN Number
    PN/A
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION.

    Additional Manufacturer Narrative · 1

    (B)(4). CONCOMITANT PRODUCTS: OXFORD FEMORAL CATALOG 161473, LOT R2498206A; OXFORD ANATOMIC BEARING CATALOG 159540, LOT 194050. 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

    IT WAS REPORTED PATIENT UNDERWENT LEFT KNEE REVISION APPROXIMATELY ONE MONTH POST-IMPLANTATION DUE TO TIBIA FRACTURE WHICH OCCURRED 16 DAYS POST-IMPLANTATION.

    Description of Event or Problem · 1

    PATIENT EXPERIENCED A LEFT PERIPROSTHETIC TIBIA FRACTURE APPROXIMATELY 16 DAYS POST IMPLANTATION. FURTHER TREATMENT IS PENDING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    840894 OXFORD PARTIAL KNEE SYSTEM SIZE B HYDROXYAPATITE COATED LEFT MEDIAL TIBIAL TRAY PROSTHESIS, KNEE NRA BIOMET UK LTD. N/A R3050460A

    Patients

    Seq Age Sex Outcome Treatment
    1 72 YR Hospitalization| R