BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VERSA-DIAL SHOULDER SYSTEM COMPREHENSIVE STANDARD ADAPTOR

    MDR report key: 2080680 · Received May 6, 2011

    Report

    Report Number
    1825034-2011-00343
    Event Type
    Injury
    Date Received
    May 6, 2011
    Date of Event
    March 22, 2011
    Report Date
    April 11, 2011
    Manufacturer
    BIOMET ORTHOPEDICS
    Product Code
    MBF
    PMA / PMN Number
    K060716
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    ND, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    USER FACILITY FORWARDED A REPORT AFTER RECEIVING A FAXED LETTER FROM BIOMET ON (B)(6), 2011 WITH EVENT DETAILS. THIS FOLLOW-UP REPORT IS BEING FILED TO MAKE THE FDA AWARE THAT BOTH THE MANUFACTURER REPORT NUMBER AND ATTACHED USER FACILITY REPORT ARE FOR THE SAME PATIENT, PART NUMBER AND EVENT. THIS REPORT FILED (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. THERE ARE WARNINGS IN THE PACKAGE INSERT THAT STATE THAT THIS TYPE OF EVENT CAN OCCUR: UNDER WARNINGS, NUMBER TWO STATES, "FAILURE TO PROPERLY ALIGN AND COMPLETELY SEAT THE COMPONENTS TOGETHER CAN LEAD TO DISASSOCIATION." 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 REVERSE SHOULDER ARTHROPLASTY ON (B)(6) 2011. SUBSEQUENTLY, THE PATIENT WAS REVISED ON (B)(6) 2011, DUE TO DISASSOCIATION. THE TAPER ADAPTOR WAS REMOVED AND REPLACED. THE PATIENT WAS FURTHER REVISED ON (B)(6) 2011, DUE TO DISASSOCIATION. INFERIOR BONE WAS REMOVED FROM THE GLENOID AND THE TAPER ADAPTOR AND THE GLENOSPHERE BASE PLATE WERE REMOVED AND REPLACED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 VERSA-DIAL SHOULDER SYSTEM COMPREHENSIVE STANDARD ADAPTOR PROSTHESIS, SHOULDER MBF BIOMET ORTHOPEDICS N/A 925310

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R