BEUDAMED
    FDA Adverse Event Injury Summary report: N

    G7 STRAIGHT MONOBLOCK ACETABULAR SHELL INSERTER

    MDR report key: 5995211 · Received October 3, 2016

    Report

    Report Number
    0001825034-2016-03914
    Event Type
    Injury
    Date Received
    October 3, 2016
    Date of Event
    September 9, 2016
    Report Date
    September 9, 2016
    Manufacturer
    BIOMET ORTHOPEDICS
    Product Code
    PBI
    PMA / PMN Number
    PK121874
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, 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. THERE ARE WARNINGS IN THE PACKAGE INSERT THAT STATE THAT THIS TYPE OF EVENT CAN OCCUR: UNDER CARE AND HANDLING OF INSTRUMENTS, IT STATES, "SURGICAL INSTRUMENTS AND INSTRUMENT CASES ARE SUSCEPTIBLE TO DAMAGE FOR A VARIETY OF REASONS INCLUDING PROLONGED USE, MISUSE, ROUGH OR IMPROPER HANDLING." THIS REPORT IS NUMBER 2 OF 2 MDR'S FILED FOR THE SAME PATIENT (REFERENCE 1825034-2016-03913 / 003914).

    Additional Manufacturer Narrative · 1

    THIS FOLLOW-UP REPORT IS BEING FILED TO RELAY DEVICE EVALUATION, WHICH WAS UNKNOWN AT THE TIME OF THE INITIAL MEDWATCH. BASED ON THE INVESTIGATION RESULTS, THE PART IS MADE TO PRINT AND FROM CORRECT MATERIALS. VISUAL EXAMINATION OF THE INSERTER IDENTIFIED SCRATCHES AND INDENTATION ALL OVER. THIS IS AN OLD HANDLE POSSIBLY BEING USED MANY TIMES BEFORE IT FRACTURED. THE PRODUCTS LEFT CONFORMING TO PRINT AS THERE IS NO EVIDENCE THAT STATES OTHERWISE. THE EVENTS THAT MAY HAVE CONTRIBUTED TO THE FRACTURE OF THE INSTRUMENTS INCLUDE: LEVERING THE ATTACHED INSERTER HANDLE WHILE ATTEMPTING TO REPOSITION THE COMPONENT AND/OR EXCESSIVE IMPACTION FORCE, AND/OR NOT INSPECTING FOR WEAR AND DISFIGUREMENT WHICH MAY HAVE PREVENTED THE USE OF THE INSTRUMENT AND ITS FAILURE. THE ROOT CAUSE CANNOT BE DETERMINED. THERE ARE WARNINGS IN THE PACKAGE INSERT THAT STATE THAT THIS TYPE OF EVENT CAN OCCUR: UNDER CARE AND HANDLING OF INSTRUMENTS, IT STATES, "SURGICAL INSTRUMENTS AND INSTRUMENT CASES ARE SUSCEPTIBLE TO DAMAGE FOR A VARIETY OF REASONS INCLUDING PROLONGED USE, MISUSE, ROUGH OR IMPROPER HANDLING."

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING AN INITIAL TOTAL HIP ARTHROPLASTY, THE INSERTER FRACTURED DURING IMPACTION OF THE ACETABULAR CUP. A 30 MINUTE DELAY IN PROCEDURE AND THE REMOVAL OF THE CUP RESULTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    646714 G7 STRAIGHT MONOBLOCK ACETABULAR SHELL INSERTER PROSTHESIS, HIP PBI BIOMET ORTHOPEDICS N/A 666130

    Patients

    Seq Age Sex Outcome Treatment
    1 Other| R