BEUDAMED
    FDA Adverse Event Other Summary report: N

    PAR 5 ACETABULAR SHELL

    MDR report key: 1140683 · Received July 24, 2008

    Report

    Report Number
    1825034-2008-00198_2
    Event Type
    Other
    Date Received
    July 24, 2008
    Date of Event
    June 20, 2008
    Report Date
    June 24, 2008
    Manufacturer
    BIOMET, INC.
    Product Code
    JDI
    PMA / PMN Number
    K022094
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THERE HAVE BEEN NO TRENDS IDENTIFIED RELATED TO THIS TYPE OF EVENT. 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.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT PT UNDERWENT HIP ARTHROPLASTY PROCEDURE IN 2008. DURING PROCEDURE, DIFFICULTY WAS ENCOUNTERED WHEN ASSEMBLING THE ACETABULAR SHELL TO THE ILIUM FLANGE. ALTERNATE PAR 5 SHELL AND ILIUM FLANGE WERE USED TO COMPLETE THE PROCEDURE. A 45-MIN DELAY IN THE PROCEDURE WAS INCURRED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PAR 5 ACETABULAR SHELL JDI JDI BIOMET, INC. NA 644670

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN Other