BEUDAMED
    FDA Adverse Event Injury Summary report: N

    POLISHED FINNED TIB TRAY 75MM

    MDR report key: 6564917 · Received May 12, 2017

    Report

    Report Number
    0009610576-2017-00015
    Event Type
    Injury
    Date Received
    May 12, 2017
    Date of Event
    March 13, 2017
    Report Date
    May 12, 2017
    Manufacturer
    BIOMET SPAIN, S.L.
    Product Code
    KRO
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). CONCOMITANT MEDICAL PRODUCTS: VANGUARD TIBIAL BEARING, CATALOG 183640, LOT 227540; VANGUARD FEMUR LEFT 70MM, CATALOG 183132, LOT 702110. (B)(6). THIS PRODUCT IS MANUFACTURED BY ZIMMER BIOMET SPAIN AND IS NOT CLEARED OR DISTRIBUTED IN THE U.S. HOWEVER, THIS REPORT IS BEING SUBMITTED AS ZIMMER BIOMET MANUFACTURES A SIMILAR DEVICE THAT IS CLEARED AND DISTRIBUTED IN THE UNITED STATES UNDER 510(K) NUMBER K945028. CUSTOMER HAS INDICATED THAT THE PRODUCT WILL NOT BE RETURNED TO ZIMMER BIOMET FOR INVESTIGATION AS IT WAS DISCARDED. THE INVESTIGATION IS IN PROCESS. ONCE THE INVESTIGATION HAS BEEN COMPLETED, A FOLLOW-UP MDR WILL BE SUBMITTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT UNDERWENT A KNEE REVISION PROCEDURE 14 DAYS POST IMPLANTATION DUE TO THE LOCKING BAR BACKING OUT. ATTEMPTS HAVE BEEN MADE AND ADDITIONAL INFORMATION ON THE REPORTED EVENT IS UNAVAILABLE AT THIS TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    345277 POLISHED FINNED TIB TRAY 75MM PROSTHESIS, KNEE KRO BIOMET SPAIN, S.L. 2016050100

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R