BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    G7 HI-WALL ARCOMXL LNR 36MM E

    MDR report key: 8366461 · Received February 25, 2019

    Report

    Report Number
    0001825034-2019-00768
    Event Type
    Malfunction
    Date Received
    February 25, 2019
    Date of Event
    January 17, 2019
    Report Date
    June 5, 2019
    Manufacturer
    ZIMMER BIOMET, INC.
    Product Code
    JDI
    PMA / PMN Number
    K121874
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. UNIQUE IDENTIFIER (UDI) #: (B)(4). 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.

    Additional Manufacturer Narrative · 0

    THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. COMPLAINT SAMPLE WAS EVALUATED AND THE REPORTED EVENT WAS NOT CONFIRMED. VISUAL INSPECTION FOUND THE LINER TO BE IN GOOD OVERALL CONDITION. DEVICE HISTORY RECORD (DHR) WAS REVIEWED AND NO DISCREPANCIES RELEVANT TO THE REPORTED EVENT WERE FOUND. ROOT CAUSE WAS UNABLE TO BE DETERMINED AS THE NECESSARY INFORMATION TO ADEQUATELY INVESTIGATE THE REPORTED EVENT WAS NOT PROVIDED. 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.

    Description of Event or Problem · 0

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

    Additional Manufacturer Narrative · 1

    (B)(4). 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. (B)(4). ADDITIONAL CONCOMITANT MEDICAL PRODUCTS: 010000663, G7 PPS LTD ACET SHELL 52E, LOT 6405875; 010000999, G7 SCREW 6.5MM X 30MM, LOT 6223766; 010000818, G7 HI-WALL ARCOMXL LNR 36MM E, LOT 6411615; 11-363660, 36MM COCR MOD HD -6MM, LOT 542770; 11-104111, MLRY-HD POR FMRL 11X160MM, LOT 563320.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A RIGHT TOTAL HIP ARTHROPLASTY, THE LINER WOULD NOT SEAT INTO THE SHELL AFTER SEVERAL ATTEMPTS OF IMPACTION. ATTEMPTS HAVE BEEN MADE AND NO FURTHER INFORMATION HAS BEEN PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    160105 G7 HI-WALL ARCOMXL LNR 36MM E PROSTHESIS, HIP JDI ZIMMER BIOMET, INC. N/A 6411615

    Patients

    Seq Age Sex Outcome Treatment
    1