BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ASCENSION PIP

    MDR report key: 2030570 · Received March 18, 2011

    Report

    Report Number
    1651501-2011-00011
    Event Type
    Injury
    Date Received
    March 18, 2011
    Date of Event
    January 11, 2011
    Report Date
    March 18, 2011
    Manufacturer
    ASCENSION ORTHOPEDICS, INC.
    Product Code
    NEG
    PMA / PMN Number
    H010005
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KS
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    X-RAYS WERE SUPPLIED BUT WERE NOT CONCLUSIVE IN A CAUSE. AN EVALUATION OF THE RETURNED COMPONENTS WAS COMPLETED. THE FRACTURE OF THIS COMPONENT MAY BE DUE TO IMPROPER OBLIQUE OSTEOTOMY PREPARATION. IF ADD'L INFO IS OBTAINED, A SUPPLEMENT REPORT WILL BE FILED AS APPROPRIATE. CONCLUSIONS: HEAD-STEM FRACTURES, AS OBSERVED IN THE SIZE 20 PROXIMAL COMPONENT, ARE KNOWN TO OCCUR AS A RESULT OF SURGICALLY IMPACTING AN UNSUPPORTED HEAD AS A RESULT OF IMPROPER OBLIQUE OSTEOTOMY PREPARATION.

    Description of Event or Problem · 1

    THE DISTRIBUTOR REPORTED THAT A PT IN (B)(6) HAD A PROXIMAL COMPONENT FRACTURED. AN X-RAY THAT WAS SUPPLIED CONFIRMED THIS OBSERVATION. WHEN THE DEVICE WAS RETURNED AN ADD'L FRACTURED PROXIMAL COMPONENT WAS RETURNED ALONG WITH A FRACTURED DISTAL COMPONENT.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R