BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EPOLY RLC 36MM 10DEG SZ24

    MDR report key: 2842425 · Received November 21, 2012

    Report

    Report Number
    0001825034-2012-02475
    Event Type
    Injury
    Date Received
    November 21, 2012
    Date of Event
    October 30, 2012
    Report Date
    October 31, 2012
    Manufacturer
    BIOMET ORTHOPEDICS
    Product Code
    JDI
    PMA / PMN Number
    PK070399
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    PHYSICIAN

    Narratives

    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 OR DEVIATION.

    Description of Event or Problem · 1

    IT WAS REPORTED PATIENT UNDERWENT TOTAL HIP ARTHROPLASTY ON (B)(6) 2012. SUBSEQUENTLY, A REVISON PROCEDURE WAS PERFORMED (B)(6) 2012 DUE TO UNKNOWN REASON. THE CUP AND LINER WERE REMOVED AND REPLACED. ONLY THE LINER WAS MANUFACTURED IN BIOMET ORTHOPEDICS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 EPOLY RLC 36MM 10DEG SZ24 PROSTHESIS, HIP JDI BIOMET ORTHOPEDICS N/A 142760

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R