BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNK RINGLOC UNIVERSAL LINER

    MDR report key: 4211793 · Received October 29, 2014

    Report

    Report Number
    0001825034-2014-08433
    Event Type
    Injury
    Date Received
    October 29, 2014
    Date of Event
    October 8, 2014
    Report Date
    October 8, 2014
    Manufacturer
    BIOMET ORTHOPEDICS
    Product Code
    LPH
    PMA / PMN Number
    PUNKNOWN
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE PRODUCT IDENTIFICATION NECESSARY TO REVIEW MANUFACTURING HISTORY WAS NOT PROVIDED. CURRENT INFORMATION IS INSUFFICIENT TO PERMIT A CONCLUSION AS TO THE CAUSE OF THE EVENT. THERE ARE WARNINGS IN THE PACKAGE INSERT THAT STATE THAT THIS TYPE OF EVENT CAN OCCUR: UNDER POSSIBLE ADVERSE EFFECTS: "WEAR AND/OR DEFORMATION OF ARTICULATING SURFACES.

    Description of Event or Problem · 1

    IT WAS REPORTED THE PATIENT UNDERWENT TOTAL HIP ARTHROPLASTY IN 1994. SUBSEQUENTLY, THE PATIENT WAS REVISED ON (B)(6) 2014 DUE TO POLY WEAR. THE LINER AND HEAD WERE REMOVED AND REPLACED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    692355 UNK RINGLOC UNIVERSAL LINER PROSTHESIS, HIP LPH BIOMET ORTHOPEDICS N/A UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 77 YR Hospitalization| R