BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VERSA-DIAL SHOULDER SYSTEM COMPREHENSIVE STANDARD ADAPTOR

    MDR report key: 1961571 · Received January 14, 2011

    Report

    Report Number
    1825034-2011-00036
    Event Type
    Injury
    Date Received
    January 14, 2011
    Date of Event
    December 7, 2010
    Report Date
    December 16, 2010
    Manufacturer
    BIOMET ORTHOPEDICS
    Product Code
    MBF
    PMA / PMN Number
    K060716
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    EVENT DESCRIPTION: WAS UPDATED TO CLARIFY THAT THE PROCEDURE PERFORMED ON (B)(6) 2010 WAS A REVISION PROCEDURE WHERE A REVERSE TOTAL SHOULDER WAS IMPLANTED. RELEVANT HISTORY: UPDATED TO INCLUDE PATIENT HISTORY AS INDICATED ON THE ATTACHED USER FACILITY REPORT. THIS REPORT FILED MARCH 14, 2011.

    Additional Manufacturer Narrative · 1

    (B)(4).

    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 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. THIS REPORT SUBMITTED (B)(6), 2011

    Description of Event or Problem · 1

    IT WAS REPORTED THAT PATIENT UNDERWENT REVISION SHOULDER ARTHROPLASTY ON (B)(6) 2010. SUBSEQUENTLY, FOLLOW UP RADIOGRAPHS REVEALED THAT THE TAPER ADAPTER HAD DISASSOCIATED FROM THE BASEPLATE. ANOTHER REVISION PROCEDURE WAS PERFORMED ON (B)(6) 2010, WITH THE TAPER ADAPTER AND BASEPLATE BEING REMOVED AND REPLACED. THE BASEPLATE IMPLANTED ON (B)(6) 2010 WAS 5MM THICKER THAN THE ONE IMPLANTED ON (B)(6) 2010.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT PATIENT UNDERWENT REVERSE TOTAL SHOULDER ARTHROPLASTY ON (B)(6), 2010. SUBSEQUENTLY, FOLLOW UP RADIOGRAPHS REVEALED THAT THE TAPER ADAPTER HAD DISASSOCIATED FROM THE BASEPLATE. A REVISION PROCEDURE WAS PERFORMED ON (B)(6), 2010, WITH THE TAPER ADAPTER AND BASEPLATE BEING REMOVED AND REPLACED. THE BASEPLATE USED IN THE REVISION WAS 5MM THICKER THAN THE BASEPLATE USED IN THE ORIGINAL PROCEDURE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT PATIENT UNDERWENT REVERSE TOTAL SHOULDER ARTHROPLASTY ON (B)(6) 2010. SUBSEQUENTLY, FOLLOW UP RADIOGRAPHS REVEALED THAT THE TAPER ADAPTER HAD DISASSOCIATED FROM THE BASEPLATE. A REVISION PROCEDURE WAS PERFORMED ON (B)(6) 2010, WITH THE GLENOSPHERE AND TAPER ADAPTER BEING REMOVED AND REPLACED. THE BASEPLATE USED IN THE REVISION WAS 5MM THICKER THAN THE BASEPLATE USED IN THE ORIGINAL PROCEDURE.

    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 434410

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R