BEUDAMED
    FDA Adverse Event Injury Summary report: N

    COMPREHENSIVE SHOULDER SYSTEM PRIMARY STANDARD LENGTH SHOULDER STEM 13MM X 122MM

    MDR report key: 2071167 · Received April 27, 2011

    Report

    Report Number
    1825034-2011-00301
    Event Type
    Injury
    Date Received
    April 27, 2011
    Report Date
    March 30, 2011
    Manufacturer
    BIOMET ORTHOPEDICS
    Product Code
    MBF
    PMA / PMN Number
    K060692
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    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. THERE ARE WARNINGS IN THE PACKAGE INSERT THAT STATE THAT THIS TYPE OF EVENT CAN OCCUR: UNDER WARNINGS, NUMBER TWO STATES, "DISASSOCIATION OF THE HUMERAL HEAD COMPONENT FROM THE HUMERAL STEM COMPONENT HAS BEEN REPORTED. FAILURE TO PROPERLY ALIGN AND COMPLETELY SEAT THE COMPONENTS TOGETHER CAN LEAD TO DISASSOCIATION". DATE OF EVENT: UNKNOWN THE USER FACILITY WAS NOTIFIED OF THE EVENT ON (B)(6) 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 REPORT SENT APRIL 27, 2011.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT PATIENT UNDERWENT SHOULDER ARTHROPLASTY ON (B)(6) 2011. SUBSEQUENTLY, RADIOGRAPHS REVEALED DISASSOCIATION OF THE HUMERAL HEAD TAPER ADAPTOR AND STEM. A REVISION PROCEDURE WAS PERFORMED ON UNKNOWN DATE WHERE THE SURGEON RE-ENGAGED THE SAME TAPER ADAPTOR AND STEM AND NO COMPONENTS WERE REMOVED. NO FURTHER INFORMATION HAS BEEN PROVIDED TO DATE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 COMPREHENSIVE SHOULDER SYSTEM PRIMARY STANDARD LENGTH SHOULDER STEM 13MM X 122MM PROSTHESIS, SHOULDER MBF BIOMET ORTHOPEDICS N/A 736440

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R