BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ARCOS CON SZ E HI 60MM

    MDR report key: 7751336 · Received August 6, 2018

    Report

    Report Number
    0001825034-2018-05530
    Event Type
    Injury
    Date Received
    August 6, 2018
    Date of Event
    December 19, 2011
    Report Date
    September 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 · 1

    (B)(4). CONCOMITANT MEDICAL PRODUCTS: ARCOS 17 X 150 MM SPL TPR DIST, PN 11-300817 LN 660910. REGENEREX RINGLOC + MULTI HOLE, PN UNKNOWN LN UNKNOWN. FREEDOM TYPE I TAPER, PN UNKNOWN LN UNKNOWN. FREEDOM RINGLOC CONSTRAINED, PN UNKNOWN LN UNKNOWN. MULTIPLE MDR REPORTS WERE FILED FOR THIS EVENT. PLEASE SEE REPORTS: 0001825034-2018-05532. 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.

    Additional Manufacturer Narrative · 1

    (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. DEVICE HISTORY RECORD WAS REVIEWED AND NO DISCREPANCIES 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. DEVICE REMAINS IMPLANTED IN PATIENT.

    Description of Event or Problem · 1

    IT WAS REPORTED PATIENT UNDERWENT AN OPEN REDUCTION AND INTERNAL FIXATION (ORIF) DUE TO INTRA-OPERATIVE FEMORAL FRACTURE. ATTEMPTS TO OBTAIN ADDITIONAL INFORMATION HAVE BEEN MADE; HOWEVER, NO MORE IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    596422 ARCOS CON SZ E HI 60MM PROSTHESIS, HIP KWA ZIMMER BIOMET, INC. N/A 391010

    Patients

    Seq Age Sex Outcome Treatment
    1 75 YR Required Intervention