BEUDAMED
    FDA Adverse Event Injury Summary report: N

    POLISHED FINNED TIB TRAY 71MM

    MDR report key: 7780182 · Received August 14, 2018

    Report

    Report Number
    0009610576-2018-00029
    Event Type
    Injury
    Date Received
    August 14, 2018
    Date of Event
    July 9, 2013
    Report Date
    August 9, 2018
    Manufacturer
    BIOMET SPAIN, S.L.
    Product Code
    KRR
    PMA / PMN Number
    PSEE H10
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). COMBINATION OF REFERENCE AND LOT PROVIDED HAS NOT BEEN MANUFACTURED BY (B)(4)ACCORDING TO OUR ERP. 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. CONCOMITANT MEDICAL PRODUCT: ASSOCIATE PRODUCT (B)(4). MANUFACTURED DATE UNKNOWN DUE TO COMBINATION OF REFERENCE AND LOT PROVIDED IS INCORRECT. PRODUCT LOCATION UNKNOWN.

    Description of Event or Problem · 1

    A SURGERY OCCURRED FOR INFECTION. THE PROSTHESIS WAS IMPLANTED ON (B)(6) 2006 FOR KNEE ARTHROSIS. THREE COMPONENTS HAVE BEEN EXPLANTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    622538 POLISHED FINNED TIB TRAY 71MM PROSTHESIS, KNEE KRR BIOMET SPAIN, S.L. N/A 2011110282

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R