BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ASCENSION PIP

    MDR report key: 1970378 · Received January 14, 2011

    Report

    Report Number
    1651501-2011-00002
    Event Type
    Injury
    Date Received
    January 14, 2011
    Date of Event
    June 9, 2008
    Report Date
    January 14, 2011
    Manufacturer
    ASCENSION ORTHOPEDICS, INC.
    Product Code
    NEG
    PMA / PMN Number
    H010005
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    VERY LITTLE INFO WAS SUPPLIED ABOUT THIS EVENT AND ATTEMPTS ARE BEING TAKEN TO OBTAIN ANY ADDITIONAL INFO. BASED ON THE INITIAL REPORT, THERE MAY HAVE BEEN A LACK OF COMPLIANCE TO POST OPERATIVE THERAPY BY THE PT. THIS MAY HAVE CAUSED OR CONTRIBUTED TO MIGRATION OF THE DEVICE. IF ANY ADDITIONAL INFO IS OBTAINED, A SUPPLEMENTAL REPORT WILL BE SUBMITTED IF APPROPRIATE.

    Description of Event or Problem · 1

    A SURGEON HAD PERFORMED A PROXIMAL INTERPHALANGEAL JOINT ARTHROPLASTY. AFTER SURGERY, THE PT WAS HAVING WORSENING PAIN IN THE OPERATIVE FINGER AND X-RAYS SHOWED SOME MIGRATION OF THE PROXIMAL COMPONENT. THE DOCTOR DID STATE THAT THE PT HAD COMPLIANCE ISSUES THROUGHOUT HIS TREATMENT. THE PT UNDERWENT A REVISION OF THE COMPONENT. THREE WEEKS AFTER THE REVISION THE PT HAD DRAINAGE AND AN ACTIVE INFECTION. THE PT SUBSEQUENTLY UNDERWENT DEBRIDEMENT AND REMOVAL OF THE IMPLANT. THE JOINT WAS TO BE FUSSED AFTER THE INFECTION WAS RESOLVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ASCENSION PIP FINGER PYROLYTIC CARBON PROSTHESIS NEG ASCENSION ORTHOPEDICS, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 49 YR Hospitalization| R