BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ACT ARTIC HD ARCOM XL 28X46MM

    MDR report key: 8086368 · Received November 19, 2018

    Report

    Report Number
    0001825034-2018-10484
    Event Type
    Injury
    Date Received
    November 19, 2018
    Date of Event
    October 3, 2018
    Report Date
    June 20, 2019
    Manufacturer
    ZIMMER BIOMET, INC.
    Product Code
    KWY
    PMA / PMN Number
    K110555
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(4). REPORTED EVENT WAS UNABLE TO BE CONFIRMED DUE TO LIMITED INFORMATION RECEIVED FROM THE CUSTOMER. DEVICE HISTORY RECORD (DHR) WAS REVIEWED AND NO DISCREPANCIES WERE FOUND. ROOT CAUSE WAS UNABLE TO BE DETERMINED.

    Description of Event or Problem · 0

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

    Additional Manufacturer Narrative · 1

    (B)(4). CONCOMITANT MEDICAL PRODUCTS: G7 OSSEOTI MULTIHOLE 60MM G, PN 110010268, LN 3973559, G7 DUAL MOBILITY LINER 46MM G, PN 110024465, LN 705150, DELTA CERAMIC OPTION HEAD DIA2 8, PN 650-1055, LN 2897826. ASSOCIATED PRODUCTS: CER OPTION TYPE 1 TPR SLEVE +3 PE 1, PN 650-1067, LN 2887164. MULTIPLE MDR REPORTS WERE FILED FOR THIS EVENT. PLEASE SEE REPORTS: 0001825034-2018-10482, 0001825034-2018-10483, 0001825034-2018-10771. CUSTOMER HAS INDICATED THAT THE PRODUCT WILL NOT BE RETURNED TO ZIMMER BIOMET FOR INVESTIGATION. 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 A PATIENT WAS REVISED FOUR MONTHS POST IMPLANTATION DUE TO DISASSOCIATION AND DISLOCATION. ATTEMPTS HAVE BEEN MADE AND ADDITIONAL INFORMATION ON THE REPORTED EVENT IS UNAVAILABLE AT THIS TIME. NO FURTHER INFORMATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    925918 ACT ARTIC HD ARCOM XL 28X46MM PROSTHESIS HIP KWY ZIMMER BIOMET, INC. N/A 648610

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R