BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ARCOS 20X190MM SPL TPR DIST HA

    MDR report key: 7352549 · Received March 20, 2018

    Report

    Report Number
    0001825034-2018-02049
    Event Type
    Injury
    Date Received
    March 20, 2018
    Date of Event
    August 13, 2014
    Report Date
    March 20, 2018
    Manufacturer
    ZIMMER BIOMET, INC.
    Product Code
    JDI
    PMA / PMN Number
    PN/A
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SP
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). MULTIPLE MDR'S WERE SUBMITTED FOR THIS EVENT. PLEASE SEE REPORTS: 0001825034 - 2018 - 02048, 0001825034 - 2018 - 02050, 0001825034 - 2018 - 02051. CONCOMITANT MEDICAL PRODUCTS: 22-301355 ARCOS CON SZ E HI 80MM HA, LOT 766400, PT-106056 REGEN/RNGLC+ MULTI 56MM SZ 24, LOT 187210, EP-105894 EPOLY RLC 36MM 10DEG SZ24, LOT 251340, 650-0843 36MM COCR BIOMET FEM HD +6 NK, LOT 3229357. REPORT SOURCE: FOREIGN. THE EVENT OCCURRED IN (B)(6). THIS REPORT IS BEING SUBMITTED LATE AS IT HAS BEEN IDENTIFIED IN REMEDIATION. REPORTED EVENT WAS UNABLE TO BE CONFIRMED DUE TO LIMITED INFORMATION RECEIVED FROM THE CUSTOMER. DHR 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.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT UNDERWENT A TOTAL LEFT HIP ARTHROPLASTY. SUBSEQUENTLY, THE PATIENT DEVELOPED A URINARY TRACT INFECTION POST-IMPLANTATION. ATTEMPTS HAVE BEEN MADE AND NO FURTHER INFORMATION HAS BEEN MADE AVAILABLE AT THIS TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    198945 ARCOS 20X190MM SPL TPR DIST HA PROSTHESIS, HIP JDI ZIMMER BIOMET, INC. N/A 530270

    Patients

    Seq Age Sex Outcome Treatment
    1 65 YR Other