BEUDAMED
    FDA Adverse Event Injury Summary report: N

    G7 SCREW 6.5MM X 25MM

    MDR report key: 3953554 · Received July 23, 2014

    Report

    Report Number
    0001825034-2014-06411
    Event Type
    Injury
    Date Received
    July 23, 2014
    Date of Event
    July 3, 2014
    Report Date
    June 30, 2014
    Manufacturer
    BIOMET ORTHOPEDICS
    Product Code
    JDI
    PMA / PMN Number
    PK121874
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    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 THESE TYPES OF EVENTS CAN OCCUR: UNDER POSSIBLE ADVERSE EFFECTS, NUMBER 1 STATES, "MATERIAL SENSITIVITY REACTIONS." THIS REPORT IS NUMBER 4 OF 6 MDRS FILED FOR THE SAME EVENT (REFERENCE 1825034-2014-06406/06407, 06409, 06411 & 06413/06414).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT PATIENT UNDERWENT A TOTAL HIP ARTHROPLASTY ON (B)(6) 2014. DURING THE PROCEDURE, IT WAS NOTED THE LINER WOULD NOT SEAT INTO THE CUP. ANOTHER ACETABULAR CUP AND LINER WAS USED TO COMPLETE THE PROCEDURE. THERE WAS A DELAY GREATER THAN 30 MINUTES IN THE PROCEDURE. SUBSEQUENTLY, PATIENT UNDERWENT A REVISION PROCEDURE ON (B)(6) 2014 DUE TO ALLEGED INFECTION. AN INVOICE HISTORY COULD NOT BE LOCATED TO CONFIRM THE SURGERY DATES AND WHICH COMPONENTS WERE REMOVED AND REPLACED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    429887 G7 SCREW 6.5MM X 25MM PROSTHESIS, HIP JDI BIOMET ORTHOPEDICS N/A 3123377

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R