BEUDAMED
    FDA Adverse Event Injury Summary report: N

    G7 SCREW 6.5MM X 25MM

    MDR report key: 6751341 · Received July 28, 2017

    Report

    Report Number
    0001825034-2017-05223
    Event Type
    Injury
    Date Received
    July 28, 2017
    Date of Event
    June 27, 2017
    Report Date
    March 30, 2018
    Manufacturer
    BIOMET ORTHOPEDICS
    Product Code
    JDI
    PMA / PMN Number
    PK121874
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    UPON RECEIPT OF INFORMATION RECEIVED AND REASSESSMENT OF THE REPORTED EVENT, IT WAS DETERMINED TO BE NOT REPORTABLE. THE INITIAL REPORT WAS FORWARDED IN ERROR AND SHOULD BE VOIDED.

    Additional Manufacturer Narrative · 1

    (B)(4). CONCOMITANT PRODUCT(S):- PART: 110017103 NAME: G7 FINNED 3 HOLE SHELL 52E LOT: 6038560 PART: 010000818 NAME: G7 HI-WALL ARCOMXL LNR 36MM E LOT: 6040048 UNKNOWN LINER. THE INVESTIGATION IS STILL IN PROCESS. ONCE THE INVESTIGATION IS COMPLETE A FOLLOW UP MDR WILL BE SUBMITTED. MULTIPLE MDR REPORTS WERE FILED FOR THIS EVENT, PLEASE SEE ASSOCIATE REPORTS:0001825034-2017-05218 0001825034-2017-05222, 0001825034-2017-05224.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A SURGEON HAD A DIFFICULT TIME INSERTING THE LINER INTO THE CUP. HE USED A 32 BALL IMPACTOR AND HIT HARD TOWARD THE APEX OF THE CUP. HE TRIED SEVERAL TIMES, HITTING VERY HARD, BUT AN EDGE STAYED PROUD. HE REMOVED THE SCREW AND TRIED AGAIN WITH NO SUCCESS. THE SURGEON DECIDED TO SCRAP THE LINER AND TRY A NEW ONE. NO SUCCESS. HE THEN DECIDED TO REMOVE THE CUP AND INSERTED A RINGLOC PLUS SHELL. THE LINER WAS SEATED SUCCESSFULLY AFTER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    531550 G7 SCREW 6.5MM X 25MM PROSTHESIS, HIP JDI BIOMET ORTHOPEDICS N/A 6058674

    Patients

    Seq Age Sex Outcome Treatment
    1 Other