BEUDAMED
    FDA Adverse Event Injury Summary report: N

    G7 OSSEOTI MULTIHOLE 66MM I

    MDR report key: 7806158 · Received August 22, 2018

    Report

    Report Number
    0001825034-2018-08154
    Event Type
    Injury
    Date Received
    August 22, 2018
    Date of Event
    July 10, 2018
    Report Date
    February 18, 2019
    Manufacturer
    ZIMMER BIOMET, INC.
    Product Code
    LPH
    PMA / PMN Number
    PK140669
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. COMPLAINT SAMPLE WAS EVALUATED AND THE REPORTED EVENT WAS CONFIRMED. VISUAL INSPECTION FOUND THE RIM OF THE SHELL TO BE SLIGHTLY SCUFFED, SCRATCHED, AND DINGED. SCRATCHING WAS ALSO FOUND NEAR THE APEX OF THE SHELL'S INNER RADIUS. DAMAGE TO THE BARB AND OUTER RADIUS OF THE LINER WERE FOUND DURING VISUAL INSPECTION OF THE LINERS. THE BARB HAS BEEN ROUGHENED SUCH THAT A POLY STRAND PROTRUDES FROM THE LINER IN 2 LOCATIONS. THE OUTER RADIUS IS PITTED. THE RIM OF THE LINER IS ALSO GOUGED. DHR WAS REVIEWED AND NO DISCREPANCIES 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 · 0

    NO FURTHER EVENT INFORMATION AVAILABLE AT THE TIME OF THIS REPORT.

    Additional Manufacturer Narrative · 1

    (B)(4). ADDITIONAL CONCOMITANT MEDICAL PRODUCTS: 010000750, G7 NEUTRAL ARCOMXL LNR 40MM I, 6155078; 010000828, G7 HI-WALL ARCOMXL LNR 40MM I, 3955787; 010000997, G7 SCREW 6.5MM X 20MM, 6182549; 010001001, G7 SCREW 6.5MM X 40MM, 3879260. MULTIPLE MDR REPORTS WERE FILED FOR THIS EVENT, PLEASE SEE ASSOCIATED REPORTS: 0001825034-2018-08155, 0001825034-2018-08156. PRODUCT HAS BEEN RECEIVED BY ZIMMER BIOMET AND THE INVESTIGATION IS IN PROCESS. ONCE THE INVESTIGATION HAS BEEN COMPLETED, A FOLLOW-UP MDR WILL BE SUBMITTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE TWO G7 40MM LINERS WERE NOT SEATING INTO THE G7 CUP BUT RATHER WOULD TOGGLE BACK AND FORTH. THE SCREWS WERE FULLY SEATED. THE CUP AND SCREWS WERE REMOVED AND THE PROCEDURE WAS COMPLETED WITH OTHER PRODUCTS. ATTEMPTS HAVE BEEN MADE AND ADDITIONAL INFORMATION ON THE REPORTED EVENT IS UNAVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    647808 G7 OSSEOTI MULTIHOLE 66MM I PROSTHESIS, HIP LPH ZIMMER BIOMET, INC. N/A 6002522

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention