BEUDAMED
    FDA Adverse Event Other Summary report: N

    ASCENSION PIP

    MDR report key: 1023641 · Received March 31, 2008

    Report

    Report Number
    1651501-2008-00007
    Event Type
    Other
    Date Received
    March 31, 2008
    Date of Event
    January 23, 2008
    Report Date
    March 31, 2008
    Manufacturer
    ASCENSION ORTHOPEDICS, INC.
    Product Code
    KWF
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE IMPLANT COMPONENTS SATISFIED ALL APPLICABLE MANUFACTURING SPECIFICATIONS. THE IMPLANTS DID NOT DISPLAY ANY EVIDENCE OF DAMAGE DUE TO FUNCTION OVER THE APPROXIMATELY ONE YEAR DURATION IMPLANT DURATION. THERE WAS NO EVIDENCE TO SUGGEST THAT THE DISTAL IMPLANT SURFACE CHIPS HAD EXISTED FOR A SIGNIFICANT PERIOD OF TIME.

    Description of Event or Problem · 1

    DEVICE WAS REMOVED FROM PATIENT AS IT WAS "ERODING THROUGH THE SKIN". THE SURGEON NOTED THAT THE EROSION WAS NOT CAUSED BY OPERATIVE TECH OR IMPLANTS, BUT POSSIBLE FURTHER DEGENERATIVE RHEUMATOID ARTHRITIS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ASCENSION PIP TOTAL FINGER JOINT IMPLANT KWF ASCENSION ORTHOPEDICS, INC. PIP-200 06-1220

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Other