BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AEQUALIS REVERSED GLENOID SPHERE 42MM

    MDR report key: 2322012 · Received October 18, 2011

    Report

    Report Number
    9610667-2011-00018
    Event Type
    Malfunction
    Date Received
    October 18, 2011
    Date of Event
    December 2, 2008
    Report Date
    January 23, 2009
    Manufacturer
    TORNIER INC.
    Product Code
    KWS
    PMA / PMN Number
    K030941
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    RESULTS: DEVICE HISTORY RECORD REVIEWED; PRODUCT MADE TO SPECIFICATION. X-RAYS FROM SURGERY WERE RECEIVED; UNABLE TO ASSESS ASSEMBLY OF GLENOID SPHERE WITH BASEPLATE. REVIEW OF ONE-MONTH POST-OPERATIVE RADIOGRAPHS CLEARLY SHOW DISASSEMBLY OF CONSTRUCT. ONE SCREW APPEARS TO BE IMPLANTED AT AN EXTREME ANGLE. TORNIER INC. IS SUBMITTING THIS MEDICAL DEVICE REPORT AS A RESULT OF A PROACTIVE REVIEW OF VIGILANCE EVENTS REPORTED TO (B)(4) OR OTHER COMPETENT AUTHORITIES IN (B)(4) DURING 2009 AND 2010. THE EVENTS DESCRIBED IN THIS MEDICAL DEVICE REPORT OCCURRED OUTSIDE OF THE UNITED STATES. THIS IS THE INITIAL REPORT SUBMITTED REGARDING THIS SURGICAL EVENT AND MEDICAL DEVICE.

    Description of Event or Problem · 1

    DISASSEMBLY OF THE GLENOID SPHERE AT SIX WEEKS POST-OPERATIVE REQUIRING REVISION SURGERY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 AEQUALIS REVERSED GLENOID SPHERE 42MM GLENOID SPHERE KWS TORNIER INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 70 YR Required Intervention