BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ASCENSION PIP

    MDR report key: 2193656 · Received August 1, 2011

    Report

    Report Number
    1651501-2011-00061
    Event Type
    Injury
    Date Received
    August 1, 2011
    Date of Event
    January 11, 2011
    Report Date
    August 1, 2011
    Manufacturer
    ASCENSION ORTHOPEDICS, INC.
    Product Code
    NEG
    PMA / PMN Number
    P000057
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BR
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    CHIPS IN THE COMPONENT WERE NOTED BUT IT IS BELIEVED THAT THESE MAY HAVE BEEN CAUSED BY SURGICAL HANDLING. RADIOGRAPHS WERE PROVIDED BUT THE IMAGES DID NOT SHOW ANY COMPONENT CHIPS AS NOTED ON THE RETURNED DEVICE. THE IMAGES ALSO APPEAR TO SHOW THAT THE OSTEOTOMY MAY BE ANGLED OR PT BONE GROWTH/SUBSIDENCE MAY BE CAUSING THE IMPLANT TO BE SLIGHTLY ANGLED. THESE OBSERVATIONS WERE SPECULATIVE BECAUSE OF THE ANGLE OF THE RADIOGRAPH AND LACK OF DETAIL SHOWN IN THE IMAGES. CONCLUSIONS: FRACTURE OCCURRED IN A RAPID, BRITTLE, BENDING MODE. THE FRACTURED COMPONENT SATISFIED ALL APPLICABLE MFG SPECS. THERE WERE NO INDICATIONS OF DEFECTS IN THE COMPONENT. STEM FRACTURES ARE KNOWN TO OCCUR WITH INADEQUATE LATERAL BONE SUPPORT FOR THE STEM AS MAY OCCUR SURGICALLY UPON SEATING IMPACT AS A RESULT OF INCOMPLETE BROACHING OF THE MEDULLARY CANAL OR IN TIME WITH BONE SUBSIDENCE.

    Description of Event or Problem · 1

    THE DISTRIBUTOR REPORTED THAT A MCP PROXIMAL COMPONENT WAS REMOVED FROM A PT. IT WAS REPORTED THAT THE PROXIMAL COMPONENT WAS FRACTURED. THE PT COMPLAINED OF STIFFNESS AND IT WAS NOTED THAT THE IMPLANT MAY ALSO HAVE POSSIBLY ROTATED. THIS REPORT IS FOR THE DISTAL COMPONENT WHICH WAS REMOVED DURING THE REVISION SURGERY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ASCENSION PIP FINGER PYROLYTIC CARBON PROSTHESIS NEG ASCENSION ORTHOPEDICS, INC. MCP-100-30D

    Patients

    Seq Age Sex Outcome Treatment
    1 39 YR Hospitalization| R