BEUDAMED
    FDA Adverse Event Injury Summary report: N

    POLISHED FINNED TIB TRAY 67MM

    MDR report key: 8780020 · Received July 11, 2019

    Report

    Report Number
    0009610576-2019-00011
    Event Type
    Injury
    Date Received
    July 11, 2019
    Date of Event
    June 12, 2019
    Report Date
    July 10, 2019
    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
    BE
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). CONCOMITANT MEDICAL PRODUCTS: ASSOCIATED ITEM #184704; ITEM NAME: SERIES A PAT W/WR STD 31 1 PEG; LOT # 416960; ASSOCIATED ITEM # EP-183622; ITEM NAME: E1 VNGD PS TIB BRG 63/67X12; LOT # 374740; ASSOCIATED ITEM # 183108; ITEM NAME: VAN PS OPEN INTL FEM-RT 65; LOT # J6448022. THIS DEVICE IS NOT MANUFACTURED BY ZIMMER BIOMET IN THE UNITED STATES; HOWEVER, WE ARE FILING THIS REPORT AS ZIMMER BIOMET MANUFACTURES A SIMILAR DEVICE IN THE UNITED STATES UNDER 510K NUMBER K945028. PRODUCT NOT RETURNED YET.

    Description of Event or Problem · 1

    REVISION SURGERY DUE TO LOOSENING (ABOUT 2 MONTHS AFTER IMPLANTATION). THE TIBIA HAD COME LOOSE ABOUT 2 MONTHS AFTER IMPLANTED ON (B)(6) 2019. IT IS NOT CLEAR WHEN IT BECAME LOOSE EXACTLY. THE REVISION SURGERY WAS PERFORMED ON THE (B)(6) 2019. AFTER REMOVAL OF THE IMPLANT IT WAS CLEAR THAT NO CEMENT WAS PRESENT WHILE IT WAS EXPECTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    573767 POLISHED FINNED TIB TRAY 67MM PROSTHESIS, KNEE KRO BIOMET SPAIN, S.L. N/A 2019030665

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R