BEUDAMED
    FDA Adverse Event Injury Summary report: N

    E-POLY 40MM 10DEG LNR SZ26

    MDR report key: 3103052 · Received May 9, 2013

    Report

    Report Number
    0001825034-2013-01354
    Event Type
    Injury
    Date Received
    May 9, 2013
    Date of Event
    April 10, 2013
    Report Date
    April 12, 2013
    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. THERE ARE WARNINGS IN THE PACKAGE INSERT THAT STATE THAT THIS TYPE OF EVENT CAN OCCUR: UNDER POSSIBLE ADVERSE EFFECTS, NUMBER 2 STATE, "EARLY OR LATE POSTOPERATIVE INFECTION AND ALLERGIC REACTION." REVIEW OF STERILIZATION CERTIFICATION CONFIRMS DEVICE WAS STERILIZED IN ACCORDANCE WITH ISO 11137-2.

    Description of Event or Problem · 1

    IT WAS REPORTED PATIENT UNDERWENT TOTAL HIP ARTHROPLASTY (B)(6), 2012. A SUBSEQUENT REVISION WAS PERFORMED (B)(6), 2013 DUE TO INFECTION. THE HEAD AND LINER WERE REMOVED AND REPLACED. ONLY THE LINER COMPONENT WAS BIOMET ORTHOPEDIC MANUFACTURED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    203435 E-POLY 40MM 10DEG LNR SZ26 PROSTHESIS, HIP JDI BIOMET ORTHOPEDICS N/A 486380

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R