BEUDAMED
    FDA Adverse Event Injury Summary report: N

    POLISHED FINNED TIB TRAY 75MM

    MDR report key: 8459883 · Received March 28, 2019

    Report

    Report Number
    0009610576-2019-00008
    Event Type
    Injury
    Date Received
    March 28, 2019
    Date of Event
    March 4, 2019
    Report Date
    March 26, 2019
    Manufacturer
    BIOMET SPAIN, S.L.
    Product Code
    KRO
    PMA / PMN Number
    SEE H10
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NZ
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). CONCOMITANT MEDICAL PRODUCTS: ASSOCIATED PRODUCTS: REF 183099 LOT # 918870 DESCRIPTION: VANGUARD FEMORAL PEGS SET 2; REF 183640 LOT # 678370 DESCRIPTION: VANGUARD PS TIBIAL BEARING 10X71/75MM; REF 183133 LOT # 478460 DESCRIPTION: VANGUARD PS OPEN INTERLOCK FEMORAL-LEFT 72.5; REF 184764 LOT # 230590 DESCRIPTION: BIOMET SERIES A PATELLA 31X8,3MM. REPORT SOURCE: (B)(6). 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 WARSAW MANUFACTURES A SIMILAR DEVICE THAT IS CLEARED OR DISTRIBUTED IN THE UNITED STATES UNDER 510(K) NUMBER K945028. DISCARDED BY HOSPITAL.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PATIENT UNDERWENT AN INITIAL LEFT KNEE PROCEDURE ON (B)(6) 2017. SUBSEQUENTLY, THE PATIENT WAS REVISED DUE TO PAIN, STIFFNESS AND LIMITED RANGE OF MOTION ON (B)(6) 2019. ALL COMPONENTS WERE REMOVED AND REPLACED EXCEPT THE PATELLA, WHICH WAS INTACT AND LEFT IMPLANTED. THE FEMORAL COMPONENT WAS WELL-FIXED AND REMOVED WITH A RECIPROCATING SAW AND BONE PUNCH. NO BONE LOSS WAS PRESENT. TIBIAL COMPONENT SHOWING LUCENT LINES ON X-RAY AND WAS FOUND TO BE LOOSE INTRAOPERATIVELY. REMOVED WITH OSTEOTOMES RECIPROCATING SAW. VANGUARD 360 IMPLANTED PER SURGICAL TECHNIQUE WITHOUT ANY COMPLICATIONS. A SYNOVASURE TEST WAS CONDUCTED, WHICH CAME BACK NEGATIVE FOR INFECTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    252394 POLISHED FINNED TIB TRAY 75MM PROTHESIS, KNEE KRO BIOMET SPAIN, S.L. N/A 2016050094

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R