BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FREEDOM RINGLOC CONSTRAINED 36MM / PLUS 5MM SANDARD FACE

    MDR report key: 2073144 · Received April 29, 2011

    Report

    Report Number
    1825034-2011-00316
    Event Type
    Malfunction
    Date Received
    April 29, 2011
    Date of Event
    March 28, 2011
    Report Date
    April 4, 2011
    Manufacturer
    BIOMET ORTHOPEDICS
    Product Code
    KWZ
    PMA / PMN Number
    K030047
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    PATIENT UNDERWENT HIP PROCEDURE ON (B)(6) 2011. DURING THE PROCEDURE, THE SURGEON ATTEMPTED TO INSERT AND IMPACTED THE ACETABULAR LINER FOUR TIMES INTO THE SHELL; HOWEVER, THE LINER WOULD NOT LOCK INTO THE SHELL. THE SURGERY WAS COMPLETED USING ANOTHER ACETABULAR LINER THAT WAS ON HAND WITH NO INJURY TO THE PATIENT OR DELAY IN THE SURGERY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 FREEDOM RINGLOC CONSTRAINED 36MM / PLUS 5MM SANDARD FACE PROSTHESIS, HIP KWZ BIOMET ORTHOPEDICS N/A 087470

    Patients

    Seq Age Sex Outcome Treatment
    1