BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LRE SEGMENTAL RAD STEM 6 X 55MM

    MDR report key: 2708563 · Received August 22, 2012

    Report

    Report Number
    0001825034-2012-01350
    Event Type
    Injury
    Date Received
    August 22, 2012
    Date of Event
    August 1, 2012
    Report Date
    August 1, 2012
    Manufacturer
    BIOMET ORTHOPEDICS
    Product Code
    JDC
    PMA / PMN Number
    PCUSTOM
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NL
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    EVALUATION OF DEVICE PLANNING RECORDS CONFIRMED REPORTED EVENT. THIS LOT CONSISTED OF ONE SINGLE UNIT.

    Additional Manufacturer Narrative · 1

    THE USER FACILITY IS OUTSIDE OF THE UNITED STATES. NO MEDWATCH REPORT WAS RECEIVED. 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. EVALUATION IN PROCESS BUT NOT YET COMPLETE. UPON COMPLETION OF EVALUATION, A FOLLOW UP REPORT WILL BE SENT TO THE FDA.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT PATIENT UNDERWENT PROCEDURE UTILIZING A CUSTOM IMPLANT ON (B)(6) 2012. PRIOR TO THE SURGERY, IT WAS NOTED THAT THE CUSTOM IMPLANT DID NOT INCLUDE THE NECESSARY BEARING. THE PROCEDURE HAD TO BE RESCHEDULED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 LRE SEGMENTAL RAD STEM 6 X 55MM PROSTHESIS, ELBOW JDC BIOMET ORTHOPEDICS N/A 084400

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R