BEUDAMED
    FDA Adverse Event Injury Summary report: N

    G7 SCREW 6.5MM X 40MM

    MDR report key: 5034268 · Received August 27, 2015

    Report

    Report Number
    0001825034-2015-03836
    Event Type
    Injury
    Date Received
    August 27, 2015
    Date of Event
    June 3, 2015
    Report Date
    August 27, 2015
    Manufacturer
    BIOMET ORTHOPEDICS
    Product Code
    LKD
    PMA / PMN Number
    PK121874
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CT, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THIS FOLLOW-UP REPORT IS BEING FILED TO RELAY ADDITIONAL INFORMATION, WHICH WAS UNKNOWN AT THE TIME OF THE INITIAL MEDWATCH.

    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. EXAMINATION OF RETURNED DEVICE FOUND NO EVIDENCE OF PRODUCT NON-CONFORMANCE. EVALUATION OF DEVICE FOUND EVIDENCE THAT FAILURE MODE WAS MOST LIKELY DUE TO MISALIGNMENT WHEN DRILLING OR POSITIONING THE G7 SCREW HOLE. HOWEVER, THE ROOT CAUSE OF THE EVENT COULD NOT BE CONFIRMED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT PATIENT UNDERWENT A TOTAL HIP ARTHROPLASTY ON (B)(6) 2015. DURING THE PROCEDURE, THE SCREW WOULD NOT FULLY SEAT INTO THE ACETABULAR CUP. COMPETITOR SCREWS WERE UTILIZED TO COMPLETE THE PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    566731 G7 SCREW 6.5MM X 40MM PROSTHESIS, HIP LKD BIOMET ORTHOPEDICS N/A 3446892

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention