BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ARCOS 16X190MM SPL TAPER DISTAL STEM

    MDR report key: 3914306 · Received July 3, 2014

    Report

    Report Number
    0001825034-2014-05944
    Event Type
    Injury
    Date Received
    July 3, 2014
    Date of Event
    August 19, 2013
    Report Date
    July 23, 2019
    Manufacturer
    BIOMET ORTHOPEDICS
    Product Code
    JDI
    PMA / PMN Number
    PK090757
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, 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."

    Description of Event or Problem · 1

    IT WAS REPORTED THAT PATIENT ENROLLED IN A CLINICAL STUDY AND UNDERWENT A LEFT TOTAL HIP ARTHROPLASTY ON AN UNKNOWN DATE. SUBSEQUENTLY, PATIENT UNDERWENT A REVISION PROCEDURE TO IMPLANT CEMENT SPACER MOLDS ON (B)(6) 2013 DUE TO INFECTION. PATIENT UNDERWENT A REIMPLANTATION PROCEDURE ON (B)(6) 2013. IT WAS FURTHER REPORTED THAT PATIENT UNDERWENT AN OPEN REDUCTION INTERNAL FIXATION PROCEDURE ON (B)(6) 2013 DUE TO AN ACUTE FRACTURE OF THE DISTAL FEMUR AS A RESULT OF PATIENT FALL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    389761 ARCOS 16X190MM SPL TAPER DISTAL STEM PROSTHESIS, HIP JDI BIOMET ORTHOPEDICS N/A 543020

    Patients

    Seq Age Sex Outcome Treatment
    1 55 YR Hospitalization| R