BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PIP SZ. 10 DISTAL

    MDR report key: 2612593 · Received June 1, 2012

    Report

    Report Number
    1651501-2012-00030
    Event Type
    Injury
    Date Received
    June 1, 2012
    Date of Event
    May 9, 2012
    Report Date
    June 1, 2012
    Manufacturer
    ASCENSION ORTHOPEDICS
    Product Code
    KWF
    PMA / PMN Number
    H010005
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE INVOLVED IN THE REPORTED INCIDENT IS NOT EXPECTED TO BE RECEIVED FOR EVALUATION. AN INVESTIGATION HAS BEEN INITIATED BASED UPON THE REPORTED INFORMATION.

    Description of Event or Problem · 1

    THE REPORTER STATED, "HER FINGER WAS CROOKED 3 MONTHS AFTER PROXIMAL INTERPHALANGEAL (PIP) LEFT RING FINGER JOINT REPLACEMENT. THE PROSTHESIS BULGES OUT VERY FAR ON THE SIDE NEXT TO THE INDEX FINGER. SHE CANNOT FLEX THE DISTAL JOINT ON THE FINGER. THE FINGER REMAINS VERY STIFF AFTER WEEKS OF HAND THERAPY, AND FINGER DEVIATES ABOUT 15 DEGREES FROM MIDDLE FINGER. THE PIP CLICKS WHEN BENT, AND SHE CANNOT BEND DISTAL JOINT ON SAID FINGER AT WILL; CAN ONLY FORCE DISTAL JOINT TO FLEX SLIGHTLY USING OTHER HAND. THE DISTAL JOINT HAD NO PROBLEM BEFORE SURGERY."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PIP SZ. 10 DISTAL PIP KWF ASCENSION ORTHOPEDICS

    Patients

    Seq Age Sex Outcome Treatment
    1 73 YR