BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PS CONSTRAINED INSERT XLG

    MDR report key: 6729814 · Received July 20, 2017

    Report

    Report Number
    0009610576-2017-00029
    Event Type
    Injury
    Date Received
    July 20, 2017
    Report Date
    July 20, 2017
    Manufacturer
    BIOMET SPAIN, S.L.
    Product Code
    JWH
    PMA / PMN Number
    PSEE H10
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PL
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). (B)(6). THIS PRODUCT IS MANUFACTURED BY ZIMMER BIOMET (B)(4) AND IS NOT CLEARED OR DISTRIBUTED IN THE U.S. HOWEVER, THIS REPORT IS BEING SUBMITTED AS ZIMMER BIOMET (B)(4) MANUFACTURES A SIMILAR DEVICE THAT IS CLEARED OR DISTRIBUTED IN THE UNITED STATES UNDER 510(K) NUMBER K033489.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT FOLLOWING A TOTAL KNEE ARTHROPLASTY PROCEDURE, A SCREW HAS BACKED OUT. NO REVISION PROCEDURE HAS BEEN REPORTED TO DATE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    510164 PS CONSTRAINED INSERT XLG PROSTHESIS, KNEE JWH BIOMET SPAIN, S.L. N/A 0000554090

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention