BEUDAMED
    FDA Adverse Event Injury Summary report: N

    POLISHED FINNED TIB TRAY 75MM

    MDR report key: 7658104 · Received July 3, 2018

    Report

    Report Number
    0009610576-2018-00023
    Event Type
    Injury
    Date Received
    July 3, 2018
    Report Date
    June 25, 2018
    Manufacturer
    BIOMET SPAIN, S.L.
    Product Code
    KRO
    PMA / PMN Number
    PSEE H10
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE INVOLVED PRODUCT REMAINS IMPLANTED. CONCOMITANT MEDICAL PRODUCTS: ITEM NAME: VNGD CR TIB BRG 10X71/75; REF: 183440; LOT: 989180; ITEM NAME: VANGUARD CR INTERLOK FEM - LT 70; REF: 183032; LOT: J3823466. (B)(6). 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.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT PATIENT UNDERWENT INITIAL KNEE ARTHROPLASTY ON (B)(6) 2016. SUBSEQUENTLY, PATIENT HAD COMPLICATION OF UNEXPLAINED SWELLING POSSIBLY DUE TO CELLULITIS TO CUT ON LOWER SHIN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    503026 POLISHED FINNED TIB TRAY 75MM PROSTHESIS, KNEE KRO BIOMET SPAIN, S.L. N/A 2016051859

    Patients

    Seq Age Sex Outcome Treatment
    1 59 YR Other