BEUDAMED
    FDA Adverse Event Other Summary report: N

    RADIAL HEAD - 24MM

    MDR report key: 1943815 · Received December 21, 2010

    Report

    Report Number
    3004608878-2010-00148
    Event Type
    Other
    Date Received
    December 21, 2010
    Date of Event
    December 10, 2010
    Report Date
    December 21, 2010
    Manufacturer
    INTEGRA-OHIO
    Product Code
    JDI
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    TO DATE, THE DEVICE INVOLVED IN THE REPORTED INCIDENT HAS NOT BEEN RECEIVED FOR EVAL. AN INVESTIGATION HAS BEEN INITIATED BASED UPON THE REPORTED INFO.

    Description of Event or Problem · 1

    THE REPORTER STATED THAT THE PT SUFFERED A FRACTURE - DISLOCATION OF THE ELBOW THREE MONTHS PREVIOUSLY AND WAS TREATED WITH A KATALYST BIPOLAR RADIAL HEAD SYS IMPLANT AND SOFT TISSUE RECONSTRUCTION. POSTOPERATIVELY, THE PT REPORTED SOME MECHANICAL SYMPTOMS; THE HEAD OF THE RADIUS COULD BE MADE TO CLICK IN CERTAIN LOADING POSITIONS. RADIOGRAPHS APPEAR TO SHOW THAT THE STEM OF THE IMPLANT IS DISLOCATED FROM THE HEAD. REVISION SURGERY IS PLANNED. THE PT WAS REPORTED TO HAVE BEEN COMPLIANT WITH POST OPERATIVE INSTRUCTIONS. INTEGRA HAS REQUESTED THE RETURN OF ANY PARTS THAT ARE EXPLANTED FOR EVAL. KATALYST BIPOLAR RADIAL HEAD SYS PARTS THAT WERE IMPLANTED ARE: KATALYST RADIAL HEAD SYS 24MM. CATALOGUE NUMBER 221424, LOT NUMBER 105172411055; KATALYST STEM, 7.5MM. CATALOGUE NUMBER 221675, LOT NUMBER 105187511055.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 RADIAL HEAD - 24MM KATALYST BIPOLAR RADIAL HEAD SYSTEM JDI INTEGRA-OHIO 105172411055

    Patients

    Seq Age Sex Outcome Treatment
    1 31 YR