BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ARCOS 17X150MM SPL TPR DIST HA

    MDR report key: 7602871 · Received June 14, 2018

    Report

    Report Number
    0001825034-2018-01349
    Event Type
    Injury
    Date Received
    June 14, 2018
    Date of Event
    January 11, 2016
    Report Date
    February 23, 2018
    Manufacturer
    ZIMMER BIOMET, INC.
    Product Code
    KWA
    PMA / PMN Number
    PN/A
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). MULTIPLE MDR REPORTS WERE FILED FOR THIS EVENT, PLEASE SEE ASSOCIATED REPORTS: 0001825034-2018-01348, 0001825034-2018-01350. CONCOMITANT PRODUCTS: 22-301310, ARCOS CON SZ A HI 50MM HA, 455410, 163669, 32MM MOD HD COCR STD, 00J2915341, 00662406520, BONE SCREW SELF-TAPPING 20 MM LENGTH 6.5 MM DIA., 62161132, 00-7000-054-20, TM REVISION SHELL 54MM, 62473283, 00-7115-054-32, XLPE REV LINER CONST 54X3, 62197940, 00662406550, BONE SCREW SELF-TAPPING 50 MM LENGTH 6.5 MM DIA., 61906700. REPORT SOURCE: FOREIGN. THE EVENT OCCURRED IN (B)(6). THIS REPORT IS BEING SUBMITTED LATE AS IT HAS BEEN IDENTIFIED IN REMEDIATION. 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. REPORTED EVENT WAS UNABLE TO BE CONFIRMED DUE TO LIMITED INFORMATION RECEIVED FROM THE CUSTOMER. X-RAYS WERE REVIEWED. UPON REVIEW, IT WAS NOTED THAT THERE ARE MULTIPLE METALLIC LOOSE BODIES WITHIN THE INFERIOR ASPECT OF THE JOINT SPACE WITH SURROUNDING OSSIFICATION, PRESUMABLY EVIDENCE OF METALLOSIS ALTHOUGH INFECTION CANNOT BE EXCLUDED. DHR WAS REVIEWED AND NO DISCREPANCIES WERE FOUND. REVIEW OF THE COMPLAINT HISTORY DETERMINED THAT NO FURTH ER ACTION IS REQUIRED AS NO WERE TRENDS IDENTIFIED. 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 THAT THE PATIENT REPORTED SEVERE HIP PAIN AND EXTREME DIFFICULTY PERFORMING DAILY ACTIVITIES AT 1-YEAR FOLLOW UP VISIT. PATIENT ALSO REPORTED SEVERE HIP PAIN, DIFFICULTY WALKING AND BEING UNABLE TO PERFORM USUAL ACTIVITIES AT 3-YEAR FOLLOW UP VISIT. ATTEMPTS HAVE BEEN MADE AND ADDITIONAL INFORMATION ON THE REPORTED EVENT IS UNAVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    445612 ARCOS 17X150MM SPL TPR DIST HA PROSTHESIS, HIP KWA ZIMMER BIOMET, INC. N/A 001110

    Patients

    Seq Age Sex Outcome Treatment
    1 58 YR Other