BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DISCOVERY XS HUMERAL 3.5X84MM RT FLANGE

    MDR report key: 2874089 · Received December 14, 2012

    Report

    Report Number
    0001825034-2012-02605
    Event Type
    Injury
    Date Received
    December 14, 2012
    Date of Event
    July 23, 2012
    Report Date
    December 11, 2012
    Manufacturer
    BIOMET ORTHOPEDICS
    Product Code
    JDC
    PMA / PMN Number
    PN/A
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    COMPLAINT INVESTIGATION FOUND THAT THE PATIENT LIVED AN ACTIVE LIFESTYLE AND DID NOT COMPLY WITH THE SURGEON'S DIRECTION AFTER THE OPERATION. THE IFU STATES: "PATIENT MUST AVOID LIFTING MORE THAN 5LBS WITH THE OPERATED ARM AFTER SURGERY." IT WAS REPORTED THAT BOTH OF THE ELBOW JOINTS RECEIVED A LOAD OVER 60 KGF (132.28 LBF), WHICH IS OVER 26X THE RECOMMENDED 5LB LOAD. THE ACTIVITY LEVEL OF PATIENT AND NON COMPLIANCE ARE CONCLUDED TO BE FACTORS IN THE IMPLANT FAILURE.

    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 POSSIBLE ADVERSE EFFECTS, NUMBER 14 STATES, "INTRAOPERATIVE OR POSTOPERATIVE BONE FRACTURE AND/OR POSTOPERATIVE PAIN." EVALUATION IN PROCESS BUT NOT YET COMPLETE. UPON COMPLETION OF EVALUATION, A FOLLOW UP REPORT WILL BE SENT TO THE FDA. THIS REPORT IS NUMBER 3 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. 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 XS HUMERAL 3.5X84MM RT FLANGE PROSTHESIS, SHOULDER JDC BIOMET ORTHOPEDICS N/A 321150

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R