BEUDAMED
    FDA Adverse Event Injury Summary report: N

    COMPREHENSIVE REVERSE SHOULDER HUMERAL TRAY W/ LOCKING RING

    MDR report key: 1896142 · Received November 10, 2010

    Report

    Report Number
    1825034-2010-00512
    Event Type
    Injury
    Date Received
    November 10, 2010
    Date of Event
    October 15, 2010
    Report Date
    October 15, 2010
    Manufacturer
    BIOMET ORTHOPEDICS
    Product Code
    KWS
    PMA / PMN Number
    K080642
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OR, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    IT WAS REPORTED THAT THE DOCTOR PRESENT FOR THE PROCEDURE NOTICED THAT THE LOCKING RING OF THE HUMERAL TRAY THAT IS THE SUBJECT OF THIS COMPLAINT WAS THE OPPOSITE ORIENTATION OF THE LOCKING RING IN THE HUMERAL TRAY USED TO COMPLETE THE PROCEDURE. ALL REMAINING PIECES OF THE COMPLAINT LOT WERE QUARANTINED AND ARE NOW UNDER BIOMET'S CONTROL. THIS REPORT SUBMITTED (B)(6) 2010.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT PATIENT UNDERWENT REVERSE SHOULDER ARTHROPLASTY ON (B)(6) 2010. DURING THE PROCEDURE, WHEN THE SURGEON WENT TO IMPACT THE HUMERAL POLY ONTO THE HUMERAL PLATE, THE TWO PIECES WOULD NOT SNAP TOGETHER. ANOTHER HUMERAL PLATE, POLY, AND GLENOSPHERE WERE USED TO COMPLETE THE PROCEDURE, 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 513600

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R