BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RSP

    MDR report key: 10568399 · Received September 22, 2020

    Report

    Report Number
    1644408-2020-00862
    Event Type
    Injury
    Date Received
    September 22, 2020
    Date of Event
    August 25, 2020
    Report Date
    September 22, 2020
    Manufacturer
    ENCORE MEDICAL L.P.
    Product Code
    PHX
    UDI-DI
    00888912144391
    PMA / PMN Number
    K112069
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 1

    ADDITIONAL REPORTING ON THIS EVENT WILL BE PROVIDED AS A SUPPLEMENTAL REPORT TO THIS DOCUMENT IF IT BECOMES AVAILABLE.

    Description of Event or Problem · 1

    REVISION SURGERY - THE PATIENT IS INFECTED. ALSO, THE STEM WAS LOOSE. SURGEON REMOVED EVERYTHING AND USED COBALT MV-G AS AN ANTIBIOTIC SPACER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1032780 RSP RSP BASEPLATE, 30MM, W/P2 COATING PHX ENCORE MEDICAL L.P. 508-32-204 769P1380 00888912144391

    Patients

    Seq Age Sex Outcome Treatment
    1 67 YR Required Intervention 506-03-126 LOT 834C1345| 506-03-126 LOT 834C1372| 508-00-032 LOT 855C2140| 508-32-103 LOT 864C2867| 530-08-108 LOT 406T1213