BEUDAMED
    FDA Adverse Event Injury Summary report: N

    G7 NEUTRAL ARCOMXL LNR 36MM H

    MDR report key: 8086651 · Received November 19, 2018

    Report

    Report Number
    0001825034-2018-10779
    Event Type
    Injury
    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

    (B)(4). COMPLAINT SAMPLE WAS EVALUATED AND THE REPORTED EVENT WAS CONFIRMED. VISUAL INSPECTION FOUND THE RIM TO BE GOUGED AND A SCREW HOLE PRESENT. THE SCREW HOLE EXTENDS INTO THE OUTER RADIUS. PITTING AND SCRATCHING WAS ALSO OBSERVED ON THE OUTER RADIUS. THE BARB IS SCRAPED SUCH THAT A STRAND OF POLY PROTRUDES FROM THE LINER. NO DIMENSIONAL ANALYSIS WILL BE PERFORMED DUE TO THE IMPLANTATION AND REMOVAL OF THE LINER. DEVICE HISTORY RECORD (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). 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. CONCOMITANT MEDICAL PRODUCTS: ITEM # 010000668, G7 PPS LTD ACET SHELL, LOT # 6081830 ITEM # 010000743, G7 NEUTRAL ARCOMXL LNR , LOT # 3517308, ITEM # 010000743, G7 NEUTRAL ARCOMXL LNR , LOT # 3575886. MULTIPLE REPORTS HAVE BEEN SUBMITTED FOR THIS EVENT. PLEASE SEE ASSOCIATED REPORTS: 0001825034-2018-10777, 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
    923734 G7 NEUTRAL ARCOMXL LNR 36MM H HIP PROSTHESIS PBI ZIMMER BIOMET, INC. N/A 3822583

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R