BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ARCOS 20X190MM SPLINED TAPER DISTAL

    MDR report key: 3201031 · Received July 2, 2013

    Report

    Report Number
    0001825034-2013-02446
    Event Type
    Injury
    Date Received
    July 2, 2013
    Date of Event
    May 29, 2013
    Report Date
    June 3, 2013
    Manufacturer
    BIOMET ORTHOPEDICS
    Product Code
    KWA
    PMA / PMN Number
    PK090757
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, 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 OR DEVIATION. THERE ARE WARNINGS IN THE PACKAGE INSERT THAT STATE THAT THIS TYPE OF EVENT CAN OCCUR: UNDER POSSIBLE ADVERSE EFFECTS, NUMBER 9 STATES "FATIGUE FRACTURE OF COMPONENT CAN OCCUR AS A RESULT OF LOSS OF FIXATION, STRENUOUS ACTIVITY, MALALIGNMENT, TRAUMA, NON-UNION, OR EXCESSIVE WEIGHT." DEVICE AVAILABILITY - THE DEVICE IS REPORTED TO BE AVAILABLE FOR EVALUATION; HOWEVER, IT HAS NOT BEEN RECEIVED BY BIOMET ORTHOPEDICS TO DATE. IN THE EVENT THAT THE DEVICE IS RECEIVED AND EVALUATED, A FOLLOW UP REPORT WILL BE SENT TO THE FDA TO PROVIDE RESULTS.

    Description of Event or Problem · 1

    IT WAS REPORTED PATIENT UNDERWENT HIP ARTHROPLASTY ON (B)(6) 2012. SUBSEQUENTLY, PATIENT UNDERWENT A REVISION PROCEDURE (B)(6) 2013 DUE TO FRACTURE OF THE STEM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    301702 ARCOS 20X190MM SPLINED TAPER DISTAL PROSTHESIS, HIP KWA BIOMET ORTHOPEDICS N/A 676450

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R