BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ARCOS CON SZ A HI 50MM HA

    MDR report key: 3964436 · Received July 29, 2014

    Report

    Report Number
    0001825034-2014-06514
    Event Type
    Injury
    Date Received
    July 29, 2014
    Date of Event
    July 3, 2014
    Report Date
    September 24, 2014
    Manufacturer
    BIOMET ORTHOPEDICS
    Product Code
    LPH
    PMA / PMN Number
    PUNKNOWN
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE PRODUCT IDENTIFICATION NECESSARY TO REVIEW MANUFACTURING HISTORY WAS NOT PROVIDED. CURRENT INFORMATION IS INSUFFICIENT TO PERMIT A CONCLUSION AS TO THE CAUSE OF THE EVENT. (B)(4)

    Additional Manufacturer Narrative · 1

    THE RETURNED MODULAR REVISION BONEMASTER WITH THE STEM AND BODY STILL ATTACHED WITH THE LOCKING SCREW WERE FOUND TO HAVE BEEN MANUFACTURED WITHIN SPECIFICATIONS. DIMENSIONAL ANALYSIS WAS CONDUCTED OF ALL THREE COMPONENTS AND THEY WERE CONFORMING EXCEPT THE HEAD OF THE LOCKING SCREW. VISUAL EXAMINATION REVEALED THAT THE T HANDLE USED FOR INSERTING THE SCREW WAS IN THE OFF OR LOCKED POSITION INSTEAD OF THE TORQUE LIMITING POSITION. THIS CAUSED AN OVER TORQUE OF THE SCREW WHICH MADE IT VERY DIFFICULT TO REMOVE. THE ARCOS MODULAR FEMORAL REVISION SYSTEM, SURGICAL TECHNIQUE, COVERS THE INSERTION OF THE LOCKING SCREW: ON PAGE 9 IT STATES, "TO LOCK THE DISTAL AND PROXIMAL BODY IMPLANTS, THREAD THE LOCKING SCREW INTO THE TOP OF THE CONE PROXIMAL BODY USING THE 3.5 MM HEX DRIVER AND T-HANDLE IN THE TORQUE LIMITING POSITION UNTIL A ¿CLICK¿ IS FELT AND HEARD". ALL PARTS LEFT BIOMET CONTROL CONFORMING.

    Additional Manufacturer Narrative · 1

    THIS FOLLOW-UP REPORT IS BEING FILED TO RELAY PRODUCT PART NUMBER, WHICH WAS UNKNOWN AT THE TIME OF THE INITIAL MEDWATCH.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT PATIENT UNDERWENT A TOTAL HIP ARTHROPLASTY ON (B)(6) 2014. WHILE INSERTING THE STEM, THE FEMUR FRACTURED. THE STEM WAS REMOVED AND THE PARTS WERE ATTEMPTED TO BE SEPARATED. SUBSEQUENTLY, THE LOCKING SCREW STRIPPED AND THE COMPONENTS REMAINED LOCKED TOGETHER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    440820 ARCOS CON SZ A HI 50MM HA PROSTHESIS, HIP LPH BIOMET ORTHOPEDICS N/A 201350

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R