BEUDAMED
    FDA Adverse Event Summary report: N

    COMPREHENSIVE SHOULDER INSTRUMENTS PRIMARY SHOULDER STEM INSERTER

    MDR report key: 2232495 · Received September 2, 2011

    Report

    Report Number
    1825034-2011-00781
    Date Received
    September 2, 2011
    Report Date
    August 9, 2011
    Manufacturer
    BIOMET ORTHOPEDICS
    Product Code
    LXH
    PMA / PMN Number
    EXEMPT
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    EVALUATION OF THE RETURNED DEVICE FOUND THAT IT MET SPECIFICATION. THIS REPORT FILED (B)(4), 2011.

    Additional Manufacturer Narrative · 1

    THE USER FACILITY IS OUTSIDE OF THE UNITED STATES. NO MEDWATCH REPORT WAS RECEIVED. CURRENT INFORMATION IS INSUFFICIENT TO PERMIT A CONCLUSION AS TO THE CAUSE OF THE EVENT. REVIEW OF DEVICE HISTORY RECORDS SHOW THAT LOT RELEASED WITH NO RECORDED ANOMALY OR DEVIATION. THE DEVICE LISTED IN THIS REPORT IS NOT SUBJECT OF RECALL NUMBER Z-2712-11. GENERAL WEAR, BASED ON THE AGE OF THE DEVICE, MAY HAVE CONTRIBUTED TO THE REPORTED EVENT. THIS REPORT SUBMITTED (B)(6) 2011.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT PATIENT UNDERWENT A SHOULDER ARTHROPLASTY PROCEDURE ON UNKNOWN DATE. AFTER IMPACTING THE HUMERAL STEM, THE STEM INSERTER WOULD NOT DISENGAGE, AND THE STEM PULLED OUT OF THE PATIENT'S HUMERAL. THE SURGEON PROCEEDED TO CEMENT THE HUMERAL STEM IN PLACE AND COMPLETE THE PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 COMPREHENSIVE SHOULDER INSTRUMENTS PRIMARY SHOULDER STEM INSERTER ORTHOPEDIC MANUAL SURGICAL INSTRUMENT LXH BIOMET ORTHOPEDICS N/A 867520

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R