BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ASCENSION PIP

    MDR report key: 2181233 · Received July 22, 2011

    Report

    Report Number
    1651501-2011-00056
    Event Type
    Injury
    Date Received
    July 22, 2011
    Date of Event
    June 9, 2008
    Report Date
    July 22, 2011
    Manufacturer
    ASCENSION ORTHOPEDICS, INC.
    Product Code
    KYJ
    PMA / PMN Number
    H010005
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    SOME INFO WAS SUPPLIED ABOUT THIS EVENT. THE INITIAL REPORT INDICATED THAT THE PT MAY HAVE BEEN NON-COMPLIANT TO POST OPERATIVE THERAPY. MFG RECORDS WERE REVIEWED AND DID NOT IDENTIFY ANYTHING THAT MAY HAVE CAUSED OR CONTRIBUTED TO THESE EVENTS. X-RAYS WERE OBTAINED AND REVIEWED. IT IS POSSIBLE THAT THE IMPLANTS SIZE THAT WAS IMPLANTED WERE INCORRECTLY CHOSEN. THE REVISION SURGERY THAT WAS DONE PLACED A LARGER SIZE INTO THE JOINT.

    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 FUSED AFTER THE INFECTION WAS RESOLVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ASCENSION PIP FINGER PYROLYTIC CARBON PROSTHESIS KYJ ASCENSION ORTHOPEDICS, INC. PIP-200-20P 06-0446

    Patients

    Seq Age Sex Outcome Treatment
    1 49 YR Hospitalization| R