BEUDAMED
    FDA Adverse Event Injury Summary report: N

    G7 SCREW HOLE PLUG

    MDR report key: 6595204 · Received May 26, 2017

    Report

    Report Number
    0001825034-2017-03352
    Event Type
    Injury
    Date Received
    May 26, 2017
    Date of Event
    April 17, 2017
    Report Date
    August 7, 2018
    Manufacturer
    BIOMET ORTHOPEDICS
    Product Code
    JDI
    PMA / PMN Number
    PK121874
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE FOLLOW UP REPORT IS SUBMITTED TO RELAY THE ADDITIONAL INFORMATION PROVIDED. THE COMPLAINT CANNOT BE CONFIRMED SINCE NO MEDICAL RECORDS OR X-RAYS WERE PROVIDED. REVIEW OF THE DEVICE HISTORY RECORD IDENTIFIED NO DEVIATIONS OR ANOMALIES. THE ROOT CAUSE WAS DETERMINED TO BE A SURGEON ERROR AS THE DIAMETER OF THE G7 SCREW HOLE PLUG WHICH WAS OBTAINED FROM THE REPLACEMENT PRODUCT WAS SMALLER AND OUT OF TOLERANCE WHEN COMPARED TO THE DIAMETER OF THE APICAL HOLE WHICH CAUSED THE SCREW HOLE PLUG PASSED THROUGH THE CUP AND THROUGH THE MEDIAL WALL OF THE ACETABULUM. THE USER IS AWARE OF THE ERROR. IF ANY FURTHER INFORMATION IS FOUND WHICH WOULD CHANGE OR ALTER ANY CONCLUSIONS OR INFORMATION, A SUPPLEMENTAL REPORT WILL BE FILED ACCORDINGLY. ZIMMER BIOMET WILL CONTINUE TO MONITOR FOR TRENDS.

    Additional Manufacturer Narrative · 1

    (B)(4). CONCOMITANT MEDICAL PRODUCTS - TAPERLOC MICROP LAT FMRL 12.5M/ PN 15-103206/ LN 943850; G7 HI-WALL E1 LINER 36MM D/ PN 010000934/ LN 3873818; G7 FINNED 3 HOLE SHELL 50D/ PN 110017102/ LN 3763221; 36MM COCR MOD HD -3MM/ PN 11-363661/ LN 589130. ONCE THE INVESTIGATION HAS BEEN COMPLETED, A FOLLOW UP MDR WILL BE SUBMITTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A LEFT INITIAL HIP ARTHROPLASTY, AS THE SURGEON WAS IMPLANTING AN ACETABULAR CUP THE APICAL HOLE PLUG THAT IS INCLUDED WITH THAT IMPLANT WAS DROPPED INTO AN UNSTERILE ENVIRONMENT. WHEN THE REPLACEMENT WAS OPENED, A SMALLER SIZE WAS INADVERTENTLY CHOSEN. THE PLUG FELL INTO THE ACETABULUM OF THE PATIENT. THE PATIENT RETAINED THE FOREIGN BODY AS SURGEON OPTED NOT TO CALL A GENERAL SURGEON TO REMOVE IT. THE PATIENT IS DOING WELL AT THIS POINT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    374323 G7 SCREW HOLE PLUG PROSTHESIS, HIP JDI BIOMET ORTHOPEDICS N/A 3470996

    Patients

    Seq Age Sex Outcome Treatment
    1 66 YR Other