BEUDAMED
    FDA Adverse Event Injury Summary report: N

    E-POLY 40MM RINGLOC ACETABULAR LINER +3 HI-WALL SIZE 24

    MDR report key: 1914240 · Received December 3, 2010

    Report

    Report Number
    1825034-2010-00645
    Event Type
    Injury
    Date Received
    December 3, 2010
    Date of Event
    October 5, 2010
    Report Date
    November 10, 2010
    Manufacturer
    BIOMET ORTHOPEDICS
    Product Code
    MAY
    PMA / PMN Number
    K090103
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    REVIEW OF STERILIZATION CERTIFICATION CONFIRMS DEVICES WERE STERILIZED IN ACCORDANCE WITH (B)(4) . THIS REPORT FILED (B)(6) 2010.

    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: POSSIBLE ADVERSE EFFECT #2 - EARLY OR LATE POSTOPERATIVE INFECTION AND ALLERGIC REACTION. THIS REPORT FILED (B)(6) 2010.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT PATIENT UNDERWENT HIP ARTHROPLASTY ON (B)(6) 2010. SUBSEQUENTLY, PATIENT DEVELOPED AN INFECTION AND A REVISION PROCEDURE TOOK PLACE ON (B)(6) 2010. THE MODULAR HEAD AND ACETABULAR LINER WERE REMOVED AND REPLACED AND THE AREA WAS IRRIGATED. ONLY THE LINER WAS MANUFACTURED BY BIOMET ORTHOPEDICS, INC. NO FURTHER INFORMATION HAS BEEN PROVIDED TO DATE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT PATIENT UNDERWENT HIP ARTHROPLASTY ON (B)(6) 2010. SUBSEQUENTLY, PATIENT DEVELOPED AN INFECTION AND A REVISION PROCEDURE WAS PERFORMED ON (B)(6) 2010. THE MODULAR HEAD AND ACETABULAR LINER WERE REMOVED AND REPLACED AND THE AREA WAS IRRIGATED. ONLY THE LINER WAS MANUFACTURED BY BIOMET ORTHOPEDICS, INC. NO FURTHER INFORMATION HAS BEEN PROVIDED TO DATE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 E-POLY 40MM RINGLOC ACETABULAR LINER +3 HI-WALL SIZE 24 PROSTHESIS, HIP MAY BIOMET ORTHOPEDICS N/A 819260

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R