BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    G7 NEUTRAL ARCOMXL LNR 36MM H

    MDR report key: 8086640 · Received November 19, 2018

    Report

    Report Number
    0001825034-2018-10777
    Event Type
    Malfunction
    Date Received
    November 19, 2018
    Date of Event
    October 23, 2018
    Report Date
    February 5, 2019
    Manufacturer
    ZIMMER BIOMET, INC.
    Product Code
    PBI
    PMA / PMN Number
    K121874
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    UPON RECEIPT OF ADDITIONAL INFORMATION, IT HAS BEEN DETERMINED THAT THIS DEVICE DID NOT CAUSE OR CONTRIBUTE TO THE REPORTED EVENT. THE INITIAL REPORT WAS FORWARDED IN ERROR AND SHOULD BE VOIDED.

    Description of Event or Problem · 0

    UPON RECEIPT OF ADDITIONAL INFORMATION, IT HAS BEEN DETERMINED THAT THIS DEVICE DID NOT CAUSE OR CONTRIBUTE TO THE REPORTED EVENT. THE INITIAL REPORT WAS FORWARDED IN ERROR AND SHOULD BE VOIDED.

    Additional Manufacturer Narrative · 1

    (B)(4). CUSTOMER HAS INDICATED THAT THE PRODUCT WILL NOT BE RETURNED TO ZIMMER BIOMET FOR INVESTIGATION, AS THE DEVICE REMAINS IMPLANTED. THE INVESTIGATION IS IN PROCESS. ONCE THE INVESTIGATION HAS BEEN COMPLETED, A FOLLOW-UP MDR WILL BE SUBMITTED. CONCOMITANT MEDICAL PRODUCTS: ITEM # 010000668, G7 PPS LTD ACET SHELL, LOT # 6081830. ITEM # 010000743, G7 NEUTRAL ARCOMXL LNR , LOT # 3822583. ITEM # 010000743, G7 NEUTRAL ARCOMXL LNR , LOT # 3517308. MULTIPLE REPORTS HAVE BEEN SUBMITTED FOR THIS EVENT. PLEASE SEE ASSOCIATED REPORTS: 0001825034-2018-10778, 0001825034-2018-10779, 0001825034-2018-10780.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT MULTIPLE LINERS WOULD NOT SEAT IN CUP. AFTER THE THIRD LINER, THE SURGEON REMOVED THE CUP, AND IMPLANTED AN ALTERNATE CUP. THE THIRD LINER WAS THEN USED AND SEATED SUCCESSFULLY. THE MALFUNCTION CAUSED A 45 MINUTE SURGICAL DELAY. ATTEMPTS HAVE BEEN MADE, AND NO FURTHER INFORMATION HAS BEEN PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    923471 G7 NEUTRAL ARCOMXL LNR 36MM H HIP PROSTHESIS PBI ZIMMER BIOMET, INC. N/A 3575886

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R