BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ASCENSION PIP

    MDR report key: 2120151 · Received June 6, 2011

    Report

    Report Number
    1651501-2011-00047
    Event Type
    Injury
    Date Received
    June 6, 2011
    Date of Event
    May 6, 2011
    Report Date
    June 3, 2011
    Manufacturer
    ASCENSION ORTHOPEDICS, INC.
    Product Code
    NEG
    PMA / PMN Number
    H010005
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THIS EVENT IS PENDING RETURN AND ANALYSIS OF THE IMPLANT. MANUFACTURING RECORDS DID NOT IDENTIFY ANYTHING THAT MAY HAVE CAUSED OR CONTRIBUTED TO THIS EVENT. THE INVESTIGATION IS ONGOING. A SUPPLEMENT REPORT WILL BE SUBMITTED, AS APPROPRIATE, IF ADDITIONAL INFORMATION IS OBTAINED.

    Description of Event or Problem · 1

    DOCTOR WAS REPORTING THAT HE WAS REVISING A PT THAT HE HAD IMPLANTED WITH A PIP TOTAL JOINT. THE PHYSICIAN STATED THAT THE PT HAD SEEN THE HAND THERAPIST PRIOR TO THE FIRST F/U VISIT. HE WAS IN A DYNAMIC SPLINT AND THE PIP JOINT WAS IN SLIGHT HYPEREXTENSION. THE SURGEON IMMEDIATELY CHANGES THE THERAPY REGIMEN TO A DORSAL APPROACH THERAPY. HE STATED THE HYPEREXTENSION HAS ONLY WORSENED. THEY HAVE TRIED PROLONGED PERIODS OF SPLINTING AND CASTING WITH THE PIP JOINT FLEXED OR BLOCKED. PT HAS STATED THAT HE HAS ABSOLUTELY NO PAIN, GOOD FUNCTION AND GOOD MOTION. SOME SQUEAKING BUT HE DOESN'T MIND IT. IT WAS ALSO NOTED ON X-RAY THAT THERE IS A POSSIBLE FRACTURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ASCENSION PIP FINGER PYROLYTIC CARBON PROSTHESIS NEG ASCENSION ORTHOPEDICS, INC. PIP-200-10P 09-0997

    Patients

    Seq Age Sex Outcome Treatment
    1 45 YR Required Intervention