BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PS FEMORAL COMPONENT CLOSED BOX LGE RIGHT 74 MM CEMENTED

    MDR report key: 10113851 · Received June 3, 2020

    Report

    Report Number
    0009610576-2020-00004
    Event Type
    Malfunction
    Date Received
    June 3, 2020
    Date of Event
    March 4, 2020
    Report Date
    June 3, 2020
    Manufacturer
    BIOMET SPAIN, S.L.
    Product Code
    JWH
    PMA / PMN Number
    SEE H10
    Removal / Correction Number
    N/A
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PL
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). CONCOMITANT MEDICAL PRODUCTS: REF. 7806-14-100; LOT 2010070893; DESCRIPTION: FEMORAL STEM 14X100MM W/SCREW . REF. 178905; LOT 0000517110; DESCRIPTION: PS CONSTRAINED INSERT XLG 15MM W/SCREW. FOREIGN (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 MANUFACTURES A SIMILAR DEVICE THAT IS CLEARED OR DISTRIBUTED IN THE UNITED STATES UNDER 510(K) NUMBER K143192/K093293. REMAINS IMPLANTED.

    Description of Event or Problem · 1

    IT HAS BEEN REPORTED THE PATIENT CONTACTED THE SURGEON WITH AN X-RAY SHOWING LOOSE SCREW IN KNEE IMPLANT. NO MEDICAL INTERVENTION HAS BEEN REPORTED TO DATE. ATTEMPTS HAVE BEEN MADE AND NO FURTHER INFORMATION HAS BEEN PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    578379 PS FEMORAL COMPONENT CLOSED BOX LGE RIGHT 74 MM CEMENTED PROSTHESIS, KNEE JWH BIOMET SPAIN, S.L. 177024 2010110046

    Patients

    Seq Age Sex Outcome Treatment
    1