BEUDAMED
    FDA Adverse Event Injury Summary report: N

    COMPREHENSIVE REVERSE SHOULDER HUMERAL TRAY W/ LOCKING RING

    MDR report key: 2241569 · Received September 9, 2011

    Report

    Report Number
    1825034-2011-00801
    Event Type
    Injury
    Date Received
    September 9, 2011
    Date of Event
    August 16, 2011
    Report Date
    August 16, 2011
    Manufacturer
    BIOMET ORTHOPEDICS
    Product Code
    KWS
    PMA / PMN Number
    K080642
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    DIMENSIONAL EVALUATION FOUND COMPONENT TO BE WITHIN APPROPRIATE DESIGN SPECIFICATION. THIS REPORT SUBMITTED (B)(4), 2011.

    Additional Manufacturer Narrative · 1

    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. EVALUATION IN PROCESS BUT NOT YET COMPLETE. UPON COMPLETION OF EVALUATION, A FOLLOW UP REPORT WILL BE SENT TO THE FDA. THE USER FACILITY WAS NOTIFIED OF THE EVENT ON (B)(4), 2011. TO DATE, A RESPONSE HAS NOT BEEN RECEIVED FROM THE USER FACILITY. IN THE EVENT THAT THE USER FACILITY SUBMITS A MEDWATCH REPORT, BIOMET WILL FORWARD A COPY TO THE FDA.\ THIS IS MDR ONE OF TWO (1825034-2011-00801 THROUGH 00802) FOR THIS EVENT. THIS REPORT SUBMITTED (B)(4), 2011.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT PATIENT UNDERWENT REVERSE SHOULDER ARTHROPLASTY ON (B)(6), 2011. AFTER PRESSING THE HUMERAL TRAY AND HUMERAL BEARING TOGETHER, THE SURGEON NOTED TOO MUCH MOVEMENT BETWEEN THE COMPONENTS. THE SURGEON ELECTED TO USE A DIFFERENT HUMERAL TRAY AND HUMERAL BEARING. THE PROCEDURE WAS COMPLETED, BUT ONLY AFTER A DELAY OF MORE THAN HALF AN HOUR OCCURRED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 COMPREHENSIVE REVERSE SHOULDER HUMERAL TRAY W/ LOCKING RING PROSTHESIS, SHOULDER KWS BIOMET ORTHOPEDICS N/A 641370

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R