BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ARCOS 14X190MM SPL TPR DIST HA

    MDR report key: 9654288 · Received January 31, 2020

    Report

    Report Number
    0001825034-2020-00466
    Event Type
    Malfunction
    Date Received
    January 31, 2020
    Date of Event
    November 20, 2014
    Report Date
    January 31, 2020
    Manufacturer
    ZIMMER BIOMET, INC.
    Product Code
    KWA
    PMA / PMN Number
    N/A
    Removal / Correction Number
    N/A
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SP
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THIS PRODUCT IS NOT CLEARED FOR DISTRIBUTION IN THE U.S. HOWEVER, THIS REPORT IS BEING SUBMITTED AS A SIMILAR DEVICE IS CLEARED FOR DISTRIBUTION UNDER 510K NUMBER K090757 (B)(6). CONCOMITANT MEDICAL PRODUCTS: CATALOG NUMBER: 22-301323, LOT NUMBER:915020, BRAND NAME: ARCOS CON SZ C STD 70MM HA. MULTIPLE MDR REPORTS WERE FILED FOR THIS EVENT, PLEASE SEE ASSOCIATED REPORTS: 0001825034-2017-09926. NO MEDICAL RECORDS RECEIVED. X-RAY REVIEW NOTED THE OVERALL FIT AND ALIGNMENT OF THE IMPLANT IS APPROPRIATE. POSSIBLE OSTEOPENIA. THERE IS SUGGESTION OF POSSIBLE LUCENCY INVOLVING THE MEDIAL CORTEX OF THE LEFT PROXIMAL FEMORAL DIAPHYSIS WHICH MAY REPRESENT AN INCOMPLETE FRACTURE BUT IS POORLY EVALUATED ON THESE IMAGES. 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 NOT RETURNED FOR EVALUATION.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT UNDERWENT A REVISION SURGERY. DURING THE SURGERY, THE SURGEON REPORTED DIFFICULTY IN LOCKING THE SCREW BETWEEN CONE AND DISTAL BODY COMPONENTS. THE SURGEON LEFT IT "UNTIGHT" AND STATED THE PATIENT TOLERATED THIS. NO INJURIES WERE REPORTED. ATTEMPTS HAVE BEEN MADE AND NO FURTHER INFORMATION HAS BEEN PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    117661 ARCOS 14X190MM SPL TPR DIST HA PROSTHESIS, HIP KWA ZIMMER BIOMET, INC. N/A 419040

    Patients

    Seq Age Sex Outcome Treatment
    1 82 YR