BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BIAXIAL AXLE WITH C CLIP

    MDR report key: 3133340 · Received May 29, 2013

    Report

    Report Number
    0001825034-2013-01672
    Event Type
    Injury
    Date Received
    May 29, 2013
    Date of Event
    July 22, 2013
    Report Date
    April 29, 2013
    Manufacturer
    BIOMET ORTHOPEDICS
    Product Code
    JDC
    PMA / PMN Number
    PN/A
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, 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.

    Additional Manufacturer Narrative · 1

    THIS FOLLOW-UP REPORT IS BEING FILED TO RELAY THE REVISION PROCEDURE AND REASON, WHICH WAS UNKNOWN AT THE TIME OF THE INITIAL MEDWATCH. THIS REPORT IS NUMBER 1 OF 4 MDRS FILED FOR THE SAME EVENT (REFERENCE 1825034-2013-01672 & 03094 / 03096).

    Description of Event or Problem · 1

    IT WAS REPORTED PATIENT UNDERWENT A TOTAL ELBOW ARTHROPLASTY IN 1998. SUBSEQUENTLY, A REVISION IS RECOMMENDED DUE TO A VARUS DEFORMITY AND A CLICKING FEELING. THERE HAS BEEN NO REPORTED REVISION PROCEDURE. NO FURTHER INFORMATION HAS BEEN PROVIDED TO DATE.

    Description of Event or Problem · 1

    IT WAS REPORTED PATIENT UNDERWENT A CUSTOM ELBOW ARTHROPLASTY IN 1998. SUBSEQUENTLY, PATIENT WAS REVISED ON (B)(6) 2013 DUE TO A VARUS DEFORMITY. DURING THE PROCEDURE, SURGEON NOTED A POLY PIECE FRACTURE AND METALLOSIS IN THE JOINT. SURGEON REMOVED AND REPLACED THE TWO CUSTOM AXLES, FOUR CUSTOM AXLE CLIPS AND A CUSTOM CONNECTING SEGMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    235793 BIAXIAL AXLE WITH C CLIP PROSTHESIS, ELBOW JDC BIOMET ORTHOPEDICS N/A UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R