BEUDAMED
    FDA Adverse Event Other Summary report: N

    CUSTOM FREEDOM RINGLOC CONSTRAINED LINER

    MDR report key: 958412 · Received April 23, 2007

    Report

    Report Number
    1825034-2007-00048
    Event Type
    Other
    Date Received
    April 23, 2007
    Date of Event
    March 20, 2007
    Report Date
    March 26, 2007
    Manufacturer
    BIOMET, INC.
    Product Code
    KWZ
    PMA / PMN Number
    custom
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    NO FURTHER COMPLICATIONS HAVE BEEN REPORTED. A FAX WAS SENT TO INFORM THE USER FACILITY OF THE EVENT. IN THE EVENT THAT THE USER FACILITY SUBMITS A MEDWATCH REPORT, BIOMET WILL FORWARD A COPY TO FDA. EVALUATION OF RETURNED DEVICE DETERMINED THAT THE IMPLANT DESIGN WAS NOT COMPATIBLE WITH THE EXISTING ACETABULAR SHELL COMPONENT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT PT UNDERWENT REVISION TOTAL HIP ARTHROPLASTY IN 2007. DURING PROCEDURE, PHYSICIAN WAS UNABLE TO ASSEMBLE TWO CUSTOM ACETABULAR LINERS INTO THE EXISTING ACETABULAR SHELL. AN ALTERNATE LINER COMPONENT WAS OBTAINED AND SECURED TO COMPLETE THE PROCEDURE. AS A RESULT, AN APPROXIMATE 30 MINUTE DELAY IN THE PROCEDURE WAS EXPERIENCED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CUSTOM FREEDOM RINGLOC CONSTRAINED LINER KWZ KWZ BIOMET, INC. NA 558080

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN Other