BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ARCOS 17X190MM SPL TPR DIST

    MDR report key: 7757436 · Received August 7, 2018

    Report

    Report Number
    0001825034-2018-06283
    Event Type
    Injury
    Date Received
    August 7, 2018
    Date of Event
    March 21, 2013
    Report Date
    October 17, 2018
    Manufacturer
    ZIMMER BIOMET, INC.
    Product Code
    KWA
    PMA / PMN Number
    PK090757
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(4). THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. REPORTED EVENT WAS UNABLE TO BE CONFIRMED DUE TO LIMITED INFORMATION RECEIVED FROM THE CUSTOMER. NO DEVICES WERE RECEIVED; THEREFORE THE CONDITION OF THE COMPONENTS IS UNKNOWN. DEVICE HISTORY RECORD (DHR) REVIEW WAS UNABLE TO BE PERFORMED AS THE LOT NUMBER OF THE DEVICE INVOLVED IN THE EVENT IS UNKNOWN. 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.

    Additional Manufacturer Narrative · 1

    (B)(4). CONCOMITANT MEDICAL PRODUCTS: BIOMET MODULAR COCR TYPE I TAPER, PN UNKNOWN, LN UNKNOWN; ARCOS CON SZ C STD 70MM, 11-301323, 942640; UNK SHELL, PN UNKNOWN, LN UNKNOWN. MULTIPLE MDR REPORTS WERE FILED FOR THIS EVENT. PLEASE SEE REPORTS: 0001825034-2018-06277, 0001825034-2018-06279, 0001825034-2018-06282. THE DEVICE WILL NOT BE RETURNED FOR ANALYSIS; HOWEVER, AN INVESTIGATION OF THE REPORTED EVENT IS IN PROGRESS. ONCE THE INVESTIGATION IS COMPLETED, A SUPPLEMENTAL MDR WILL BE SUBMITTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT PATIENT UNDERWENT TREATMENT FOR C-DIFF APPROXIMATELY ONE MONTH POST-IMPLANTATION. ATTEMPTS HAVE BEEN MADE AND ADDITIONAL INFORMATION ON THE REPORTED EVENT IS UNAVAILABLE AT THIS TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    601058 ARCOS 17X190MM SPL TPR DIST PROSTHESIS, HIP KWA ZIMMER BIOMET, INC. N/A 216380

    Patients

    Seq Age Sex Outcome Treatment
    1 83 YR Other