BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    POLISHED FINNED TIB TRAY 67MM

    MDR report key: 9937082 · Received April 8, 2020

    Report

    Report Number
    0009610576-2020-00002
    Event Type
    Malfunction
    Date Received
    April 8, 2020
    Date of Event
    January 26, 2015
    Report Date
    March 26, 2020
    Manufacturer
    BIOMET SPAIN, S.L.
    Product Code
    KRO
    PMA / PMN Number
    SEE H10
    Removal / Correction Number
    N/A
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IT
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). ASSOCIATED MEDICAL PRODUCTS: VANGUARD CR ILOK FEM-RT 60, REFERENCE #(B)(4), LOT # 804720 ((B)(4), LEGAL MANUFACTURER BIOMET ORTHOPEDICS, (B)(4), USA). THIS PRODUCT IS MANUFACTURED BY BIOMET (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. INCIDENT PREVIOUSLY REPORTED UNDER (B)(4) FOR PRODUCT REFERENCE #(B)(4), LOT # 804720 (LEGAL MANUFACTURER: BIOMET ORTHOPEDICS, (B)(4), USA) . NEW ADDITIONAL INFORMATION RECEIVED ON MAR 18, 2020 ((B)(4)) RELATED TO THE PRODUCT ITEM # 141252 , LOT # 2014110294 (LEGAL MANUFACTURER: BIOMET (B)(4)). REMAINS IMPLANTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT PATIENT UNDERWENT RIGHT TOTAL KNEE ARTHROPLASTY. SUBSEQUENTLY, IT IS ALLEGED THAT THERE IS LOOSENING OF THE PROSTHESES, AND INSTABILITY. NO REVISION HAS BEEN REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    401397 POLISHED FINNED TIB TRAY 67MM PROSTHESIS, KNEE KRO BIOMET SPAIN, S.L. N/A 2014110294

    Patients

    Seq Age Sex Outcome Treatment
    1