BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ARCOS CON SZ B STD 70MM

    MDR report key: 7067776 · Received November 29, 2017

    Report

    Report Number
    0001825034-2017-09280
    Event Type
    Injury
    Date Received
    November 29, 2017
    Date of Event
    February 23, 2017
    Report Date
    October 19, 2017
    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
    GA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). MULTIPLE MDR'S WERE SUBMITTED FOR THIS EVENT. PLEASE SEE REPORTS: 0001825034 - 2017 - 09280, 0001825034 - 2017 - 09281, 0001825034 - 2017 - 09282. (B)(4. CONCOMITANT PRODUCTS: XL-200150 ACT ARTIC HD ARCOM XL 28X44MM 815090. 163660 28MM DIA COCR MOD HD -6MM NK 806980. 430052 THIN OSTEOTOME BLADE 8MM 435582. 11-300912 ARCOS 12X190MM SPL TPR DIST 303710. REPORTED EVENT WAS UNABLE TO BE CONFIRMED DUE TO LIMITED INFORMATION RECEIVED FROM THE CUSTOMER. DHR WAS REVIEWED AND NO DISCREPANCIES WERE FOUND. REVIEW OF THE COMPLAINT HISTORY DETERMINED THAT NO FURTHER ACTION IS REQUIRED. SECONDARY REVISION OP NOTES INDICATES PATIENT UNDERWENT UNCOMPLICATED TOTAL HIP ARTHOPLASTY OBSERVED GENTLE RANGE OF MOTION WITHOUT CREPITUS. 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.

    Description of Event or Problem · 1

    IT WAS REPORTED THE PATIENT WAS REVISED DUE TO PAIN. NO FURTHER INFORMATION HAS BEEN MADE AVAILABLE AT THIS TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    846217 ARCOS CON SZ B STD 70MM PROSTHESIS, HIP KWA ZIMMER BIOMET, INC. N/A 769440

    Patients

    Seq Age Sex Outcome Treatment
    1 68 YR Hospitalization| R