BEUDAMED
    FDA Adverse Event Death Summary report: N

    ARCOS BRCH SZ F HI 60MM

    MDR report key: 5011344 · Received August 18, 2015

    Report

    Report Number
    0001825034-2015-03653
    Event Type
    Death
    Date Received
    August 18, 2015
    Date of Event
    August 12, 2015
    Report Date
    December 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
    AS
    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. THIS REPORT IS NUMBER 2 OF 2 MDR'S FILED FOR THE SAME EVENT (REFERENCE 1825034-2015-03653 AND 03654).

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    IT WAS REPORTED PATIENT UNDERWENT A LEFT TOTAL HIP ARTHROPLASTY ON (B)(6), 2012. SUBSEQUENTLY, PATIENT WAS REVISED ON (B)(6) 2014 DUE TO INSTABILITY. THE MODULAR HEAD AND COMPETITOR LINER WERE REMOVED AND REPLACED. PATIENT UNDERWENT A FURTHER REVISION PROCEDURE ON (B)(6) 2015 DUE TO A STEM FRACTURE. DURING THE PROCEDURE, THE STEM WAS DIFFICULT TO REMOVE. PATIENT EXPIRED DURING THE PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    545213 ARCOS BRCH SZ F HI 60MM PROSTHESIS, HIP KWA BIOMET ORTHOPEDICS N/A 303360

    Patients

    Seq Age Sex Outcome Treatment
    1 39 YR Death