BEUDAMED
    FDA Adverse Event Injury Summary report: N

    FREEDOM CONSTRAINED ACETABULAR CUP ALL POLY STANDARD FACE LINER 50MM X 36MM

    MDR report key: 1904656 · Received November 22, 2010

    Report

    Report Number
    1825034-2010-00588
    Event Type
    Injury
    Date Received
    November 22, 2010
    Date of Event
    October 1, 2009
    Report Date
    October 19, 2010
    Manufacturer
    BIOMET ORTHOPEDICS
    Product Code
    KWZ
    PMA / PMN Number
    K030047
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    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. REVIEW OF STERILIZATION CERTIFICATION CONFIRMS DEVICES WERE STERILIZED IN ACCORDANCE WITH (B)(4) . 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

    INFORMATION RECEIVED SUGGESTS PATIENT UNDERWENT REVISION HIP ARTHROPLASTY DUE TO METAL HYPERSENSITIVITY AND INFECTION. REVIEW OF INVOICE HISTORY REVEALED THAT PATIENT HAS A RECORD OF REVISIONS FOR UNKNOWN REASONS. SUBSEQUENTLY, PATIENT WAS REVISED AGAIN ON (B)(6) 2009. NO FURTHER DETAILS HAVE BEEN PROVIDED TO DATE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 FREEDOM CONSTRAINED ACETABULAR CUP ALL POLY STANDARD FACE LINER 50MM X 36MM PROSTHESIS, HIP KWZ BIOMET ORTHOPEDICS N/A 895530

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R