BEUDAMED
    FDA Adverse Event Injury Summary report: N

    G7 STR MONOBLOCK SHELL INSRTR

    MDR report key: 7419530 · Received April 10, 2018

    Report

    Report Number
    0001825034-2018-02298
    Event Type
    Injury
    Date Received
    April 10, 2018
    Date of Event
    March 14, 2018
    Report Date
    October 2, 2018
    Manufacturer
    ZIMMER BIOMET, INC.
    Product Code
    LXH
    PMA / PMN Number
    PN/A
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). CONCOMITANT MEDICAL PRODUCTS: 010000667, G7 PPS LTD ACET SHELL 60G, 6202636. REPORT SOURCE, FOREIGN - THE EVENT OCCURRED IN (B)(6). CUSTOMER HAS INDICATED THAT THE PRODUCT IS IN PROCESS OF BEING RETURNED TO ZIMMER BIOMET FOR INVESTIGATION. ONCE THE INVESTIGATION HAS BEEN COMPLETED, A FOLLOW-UP MDR WILL BE SUBMITTED. MULTIPLE MDR REPORTS WERE FILED FOR THIS EVENT, PLEASE SEE ASSOCIATED REPORTS: 0001825034 - 2018 - 02297.

    Additional Manufacturer Narrative · 1

    THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL AND CORRECTED INFORMATION. COMPLAINT SAMPLE WAS EVALUATED AND THE REPORTED EVENT WAS NOT CONFIRMED. DHR WAS REVIEWED AND NO DISCREPANCIES RELEVANT TO THE REPORTED EVENT WERE FOUND. ROOT CAUSE WAS UNABLE TO BE DETERMINED. IF ANY FURTHER INFORMATION IS FOUND WHICH WOULD CHANGE OR ALTER ANY CONCLUSIONS OR INFORMATION, A SUPPLEMENTAL WILL BE FILED ACCORDINGLY. ZIMMER BIOMET WILL CONTINUE TO MONITOR FOR TRENDS.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE SURGEON ATTEMPTED TO REMOVE THE INSERTER FROM THE IMPLANTED SHELL BUT QUICKLY DISCOVERED THAT THE INSERTER HANDLE COULD NOT BE UNTHREADED. AFTER FURTHER ATTEMPTS AND NO LONGER WANTING TO DELAY THE SURGERY, THE SURGEON REQUESTED A SECOND IMPLANT TO BE OPENED AND INSERTED. THE SURGEON THEN USED THE SHELL INSERTER TO ATTACH THE SECOND SHELL. THE SURGEON THEN IMPACTED THE SHELL INTO THE ACETABULUM AND SUBSEQUENTLY REMOVED THE CURVED INSERTER HANDLE WITH NO ISSUE. THE SURGERY WAS THEN CARRIED ON WITHOUT FURTHER ISSUE. ATTEMPTS HAVE BEEN MADE AND ADDITIONAL INFORMATION ON THE REPORTED EVENT IS UNAVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    262973 G7 STR MONOBLOCK SHELL INSRTR SURGICAL, INSTRUMENT LXH ZIMMER BIOMET, INC. N/A 395880

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention