BEUDAMED
    FDA Adverse Event Injury Summary report: N

    APTIS DRUJ

    MDR report key: 13018493 · Received December 16, 2021

    Report

    Report Number
    3004521401-2021-00001
    Event Type
    Injury
    Date Received
    December 16, 2021
    Date of Event
    November 17, 2021
    Report Date
    December 16, 2021
    Manufacturer
    APTIS MEDICAL
    Product Code
    KXE
    UDI-DI
    B013DRUJLP100
    PMA / PMN Number
    K142569
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    ONCE NOTIFIED VIA E-MAIL IT WAS NOTED THE COVER HAD BROKEN FREE FROM THE RADIAL PLATE AND THE PLATE ITSELF WAS EXTREMELY DORSALLY ANGULATED. CONTACT WITH THE SURGEON WAS MADE ON (B)(6) 2021 TO GATHER FURTHER INFORMATION. THE SURGEON STATED THE PATIENT FELT THE PROSTHESIS BREAK AS SHE WAS USING HER ARMS TO LIFT HERSELF OUT OF A CHAIR. THE SURGEON STATED THAT HE DID NOT FOLLOW THE TECHNICAL GUIDANCE AND POSITIONED THE PLATE DORSALLY ANGULATED DUE TO THE SHAPE OF THE RADIUS. HE ALSO ACKNOWLEDGED THAT ALL GUIDANCE REQUIRES THE PLATE TO BE PROPERLY POSITIONED BUT HE FELT THE ALTERED POSITIONING WOULD BE ACCEPTABLE. THE DEVICE FAILED DUE TO THE MAL-POSITIONING WHICH ALTERED THE FORCES PASSING THROUGH THE DEVICE TO AN EXTREME.

    Description of Event or Problem · 0

    PATIENT WAS TRYING TO GET UP OUT OF A CHAIR AND FELT THE IMPLANT BREAK.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1914574 APTIS DRUJ APTIS DRUJ KXE APTIS MEDICAL DRUJLP10 9448235 B013DRUJLP100

    Patients

    Seq Age Sex Outcome Treatment
    1 62 YR Female Required Intervention