BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    G7 STR MODULAR SHELL INSERTER

    MDR report key: 7827794 · Received August 29, 2018

    Report

    Report Number
    0001825034-2018-08565
    Event Type
    Malfunction
    Date Received
    August 29, 2018
    Date of Event
    August 6, 2018
    Report Date
    May 16, 2019
    Manufacturer
    ZIMMER BIOMET, INC.
    Product Code
    LXH
    PMA / PMN Number
    PEXEMPT
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    UPON REASSESSMENT IT WAS FOUND THAT NO FAILURE WAS ALLEGED AGAINST THE DEVICE. THE INITIAL REPORT WAS FORWARDED IN ERROR AND SHOULD BE VOIDED.

    Description of Event or Problem · 0

    UPON REASSESSMENT IT WAS FOUND THAT NO FAILURE WAS ALLEGED AGAINST THE DEVICE. THE INITIAL REPORT WAS FORWARDED IN ERROR AND SHOULD BE VOIDED.

    Additional Manufacturer Narrative · 1

    (B)(4). MEDICAL DEVICES: 010002736, G7 BALL HEX DRVR FOR INSR HNDL 395400, 110010247, G7 OSSEOTI 4 HOLE SHELL 58MM G, 3973486. MULTIPLE MDR REPORTS WERE FILED FOR THIS EVENT, PLEASE SEE ASSOCIATED REPORTS: 0001825034-2018-08564. THE DEVICE WILL NOT BE RETURNED FOR ANALYSIS; HOWEVER, AN INVESTIGATION OF THE REPORTED EVENT IS IN PROGRESS. ONCE THE INVESTIGATION IS COMPLETED, A SUPPLEMENTAL MDR WILL BE SUBMITTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A HIP PROCEDURE THE HEX DRIVER SNAPPED OFF AND BROKE. THIS LEFT THE SHELL INSERTER STUCK TO THE IMPLANTED SHELL WITH NO WAY TO REMOVE. THE SHELL WAS THEN EXPLANTED AND A DIFFERENT SHELL WAS IMPACTED USING A DIFFERENT INSERTER. ATTEMPTS HAVE BEEN MADE AND ADDITIONAL INFORMATION ON THE REPORTED EVENT IS UNAVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    670084 G7 STR MODULAR SHELL INSERTER PROSTHESIS, HIP LXH ZIMMER BIOMET, INC. N/A 423350

    Patients

    Seq Age Sex Outcome Treatment
    1 56 YR Required Intervention