BEUDAMED
    FDA Adverse Event Injury Summary report: N

    COMPREHENSIVE REVERSE SHOULDER CENTRAL SCREW

    MDR report key: 2132910 · Received June 17, 2011

    Report

    Report Number
    1825034-2011-00514
    Event Type
    Injury
    Date Received
    June 17, 2011
    Date of Event
    May 17, 2011
    Report Date
    May 25, 2011
    Manufacturer
    BIOMET ORTHOPEDICS
    Product Code
    KWS
    PMA / PMN Number
    UNKNOWN
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    CURRENT INFORMATION IS INSUFFICIENT TO PERMIT A CONCLUSION AS TO THE CAUSE OF THE EVENT. THERE ARE WARNINGS IN THE PACKAGE INSERT THAT STATE THAT THIS TYPE OF EVENT CAN OCCUR: UNDER POSSIBLE ADVERSE EFFECTS, (B)(4) STATES, "FATIGUE FRACTURE OF COMPONENT CAN OCCUR AS A RESULT OF LOSS OF FIXATION, STRENUOUS ACTIVITY, MALALIGNMENT, TRAUMA, NON-UNION, OR EXCESSIVE WEIGHT". POSSIBLE ADVERSE EFFECT (B)(4) STATES, "IF GLENOID COMPONENT IS NOT SECURELY FIXED, MICROMOTION CAN LEAD TO PERIPHERAL SCREW FAILURE." THE PART AND LOT NUMBER INFORMATION NEEDED TO REVIEW DEVICE HISTORY RECORDS WAS UNAVAILABLE. THE GLENOSPHERE ASSEMBLY WAS RETURNED FULLY ASSEMBLED WITH A GLENOSPHERE, GLENOSPHERE BASEPLATE, AND FIVE SCREWS. THE CENTRAL SCREW AND TWO OF THE PERIPHERAL SCREWS WERE FRACTURED. NO ATTEMPT WAS MADE TO DISASSEMBLE THE EXPLANTS. THE CENTRAL SCREW'S FRACTURE HAS FEATURES CONSISTENT WITH A FATIGUE FRACTURE. THE SCREW FRACTURE SEQUENCE IS 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. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT PATIENT UNDERWENT SHOULDER ARTHROPLASTY ON (B)(6) 2010, WHERE A COMPETITOR'S TOTAL SHOULDER COMPONENTS WERE REMOVED AND REPLACED WITH A REVERSE SHOULDER SYSTEM. A SUBSEQUENT REVISION PROCEDURE WAS PERFORMED ON (B)(6) 2011, DUE TO FRACTURE OF THE CENTRAL SCREW AND TWO PERIPHERAL SCREWS AND LOSS OF FIXATION OF THE BASEPLATE. ALL COMPONENTS WERE REMOVED AND REPLACED WITH A HEMI-ARTHROPLASTY SYSTEM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 COMPREHENSIVE REVERSE SHOULDER CENTRAL SCREW PROSTHESIS, SHOULDER KWS BIOMET ORTHOPEDICS N/A UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R