BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DISCOVERY ELBOW XS HUMERAL CONDYLE KIT - HEXALOBULAR

    MDR report key: 2658131 · Received July 17, 2012

    Report

    Report Number
    0001825034-2012-01036
    Event Type
    Injury
    Date Received
    July 17, 2012
    Date of Event
    July 23, 2012
    Report Date
    June 20, 2012
    Manufacturer
    BIOMET ORTHOPEDICS
    Product Code
    JDC
    PMA / PMN Number
    PK090473
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE USER FACILITY IS OUTSIDE OF THE UNITED STATES. NO MEDWATCH REPORT WAS RECEIVED. 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 POSSIBLE ADVERSE EFFECTS, NUMBER 6 STATES, "LOOSENING, MIGRATION, AND/OR FRACTURE OF THE IMPLANTS CAN OCCUR DUE TO LOSS OF FIXATION, TRAUMA, MALALIGNMENT, BONE RESORPTION, AND/OR EXCESSIVE ACTIVITY." THIS REPORT IS NUMBER 1 OF 2 MDRS FILED FOR THE SAME EVENT (REFERENCE 1825034-2012-01038).

    Additional Manufacturer Narrative · 1

    DIMENSIONAL EVALUATION FOUND COMPONENT TO BE WITHIN APPROPRIATE DESIGN SPECIFICATION. IT WAS STATED THE PATIENT DID NOT COMPLY WITH SURGEON WARNINGS. THE ACTIVITY LEVEL OF PATIENT AND NON COMPLIANCE WERE SIGNIFICANT FACTORS IN THE IMPLANT FAILURE. THIS REPORT IS NUMBER 1 OF 2 MDRS FILED FOR THE SAME EVENT (REFERENCE 1825034-2012-01036-1 AND 01038-1).

    Additional Manufacturer Narrative · 1

    THIS PRODUCT WAS IMPLANTED IN (B)(6) 2011 AND REVISED IN (B)(6) 2012. THE REVISION WAS DUE TO A HUMERAL FRACTURE. THIS REPORT IS NUMBER 1 OF 3 MDRS FILED FOR THE SAME EVENT (REFERENCE 1825034-2012-01036-2, 01038-2 & 02605).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT PATIENT UNDERWENT TOTAL ELBOW ARTHROPLASTY ON (B)(6), 2010. SUBSEQUENTLY, PATIENT WAS REVISED ON (B)(6), 2011, FOR AN UNKNOWN REASON. THE CONDYLE KIT WAS REMOVED AND REPLACED. THE PATIENT IS SCHEDULED TO UNDERGO A SECOND REVISION PROCEDURE DUE TO LOOSENING OF THE HEXALOBULAR SCREW OF THE CONDYLE KIT. NO FURTHER INFORMATION HAS BEEN PROVIDED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT PATIENT UNDERWENT TOTAL ELBOW ARTHROPLASTY ON (B)(6) 2010. SUBSEQUENTLY, PATIENT WAS REVISED ON (B)(6) 2011, FOR AN UNKNOWN REASON. THE CONDYLE KIT WAS REMOVED AND REPLACED. FURTHER, PATIENT WAS AGAIN REVISED ON (B)(6) 2012 DUE TO A PERIPROSTHETIC HUMERAL FRACTURE. ALL COMPONENTS WERE REMOVED AND REPLACED WITH A COMPETITOR'S PRODUCTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 DISCOVERY ELBOW XS HUMERAL CONDYLE KIT - HEXALOBULAR PROSTHESIS, ELBOW JDC BIOMET ORTHOPEDICS N/A 200330

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R