BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ARCOS CON SZ B HI 70MM

    MDR report key: 5011519 · Received August 18, 2015

    Report

    Report Number
    0001825034-2015-03656
    Event Type
    Injury
    Date Received
    August 18, 2015
    Date of Event
    July 29, 2015
    Report Date
    November 30, 2015
    Manufacturer
    BIOMET ORTHOPEDICS
    Product Code
    KWA
    PMA / PMN Number
    PK090757
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    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. THERE ARE WARNINGS IN THE PACKAGE INSERT THAT STATE THAT THIS TYPE OF EVENT CAN OCCUR: UNDER POSSIBLE ADVERSE EFFECTS, NUMBER 4 STATES, ¿LOOSENING OR MIGRATION OF THE IMPLANTS CAN OCCUR DUE TO LOSS OF FIXATION, TRAUMA, MALALIGNMENT, MALPOSITION, BONE RESORPTION, OR EXCESSIVE UNUSUAL AND/OR AWKWARD MOVEMENT AND/OR ACTIVITY.¿ 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 2 OF 2 MDR'S FILED FOR THE SAME EVENT (REFERENCE 1825034-2015-03655 AND 1825034-2015-03656).

    Additional Manufacturer Narrative · 1

    THIS FOLLOW-UP REPORT IS BEING FILED TO RELAY ADDITIONAL INFORMATION, WHICH WAS UNKNOWN AT THE TIME OF THE INITIAL MEDWATCH. PRODUCT LEFT CONFORMING TO PRINT AS THERE WAS NO EVIDENCE THAT STATES OTHERWISE. THE FEMORAL STEM WAS RETURNED WITH SCRATCHING AND DAMAGE TO THE TAPER, WHICH LIKELY OCCURRED AFTER THE DISASSOCIATION. THE LOCKING SCREW WAS INDEPENDENTLY TESTED WITH THE FEMORAL STEM AND WAS ABLE TO BE THREADED FULLY INTO THE STEM. THE LOCKING SCREW SERVES AS A SECONDARY LOCKING MECHANISM, WHICH WAS LIKELY NEVER FULLY ENGAGED, BUT THE TAPER MECHANISM WHICH SERVES AS THE PRIMARY LOCKING MECHANISM ALSO FAILED RESULTING IN THE DISASSOCIATION. A DEFINITIVE ROOT CAUSE FOR THE DISASSOCIATION CANNOT BE DETERMINED WITH THE INFORMATION PROVIDED. BASED ON THESE RESULTS THE COMPLAINT IS CONSIDERED CONFIRMED.

    Additional Manufacturer Narrative · 1

    THIS FOLLOW-UP REPORT IS BEING FILED TO RELAY CORRECTED INFORMATION.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT UNDERWENT AN INITIAL RIGHT TOTAL HIP ARTHROPLASTY ON (B)(6) 2015. SUBSEQUENTLY, THE PATIENT WAS REVISED ON (B)(6) 2015 DUE TO A DISENGAGED TAPER ADAPTER CAUSING THE FEMORAL COMPONENT TO BE UNSTABLE. DURING THE PROCEDURE, IT WAS NOTED THE LOCKING SCREW WAS NOT INITIALLY ENGAGED AND A LOOSE STEM. THE FEMORAL STEM, LOCKING SCREW, CONE BODY AND MODULAR HEAD WERE REMOVED AND REPLACED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT UNDERWENT AN INITIAL RIGHT TOTAL HIP ARTHROPLASTY ON (B)(6) 2015. SUBSEQUENTLY, THE PATIENT WAS REVISED ON (B)(6) 2015 DUE TO A DISENGAGED PROXIMAL BODY CAUSING THE DISTAL STEM TO BE UNSTABLE. DURING THE PROCEDURE, IT WAS NOTED THE LOCKING SCREW WAS NOT INITIALLY ENGAGED AND A LOOSE STEM. THE FEMORAL STEM, LOCKING SCREW, CONE BODY AND MODULAR HEAD WERE REMOVED AND REPLACED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    545468 ARCOS CON SZ B HI 70MM PROSTHESIS, HIP KWA BIOMET ORTHOPEDICS N/A 275400

    Patients

    Seq Age Sex Outcome Treatment
    1 89 YR Hospitalization| R