BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ARCOS 18X150MM SPL TPR DIST

    MDR report key: 7530080 · Received May 21, 2018

    Report

    Report Number
    0001825034-2018-01359
    Event Type
    Injury
    Date Received
    May 21, 2018
    Date of Event
    November 6, 2015
    Report Date
    June 15, 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
    UK
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    ZIMMER BIOMET COMPLAINT (B)(4). MULTIPLE MDR REPORTS WERE FILED FOR THIS EVENT, PLEASE SEE ASSOCIATED REPORTS: 0001825034-2018-01358, 0001825034-2018-01360. CONCOMITANT MEDICAL PRODUCTS: CAT 11-301312 ¿ LOT 910870 - ARCOS CON, CAT 163669 ¿ LOT 0000627869 - MOD HD COCR STD. 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. THIS REPORT IS BEING SUBMITTED LATE AS IT HAS BEEN IDENTIFIED IN REMEDIATION. NOT RETURNED TO MANUFACTURER.

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    CLINICAL STUDY 530 REPORTED THAT A PATIENT UNDERWENT REVISION SURGERY FOR RIGHT HIP, AND 3 YEARS POST OP REVISION SURGERY IT WAS REPORTED FOR MODERATE PAIN, TOLERABLE MAKES CONCESSIONS TO PAIN, SOME LIMITATION OF ORDINARY ACTIVITY OR WORK, FOR WALKING MAXIMUM DISTANCE HAVE MODERATE LIMP, NEEDS 2 CANES FOR SUPPORT, UNABLE TO USE PUBLIC TRANSPORTATION AND UNABLE TO TIE SHOES OR WEAR SOCKS. IT WAS ALSO REPORTED THAT WITH EXTREME DIFFICULTY GETTING IN AND OUT OF CAR, MODERATE TROUBLE IN WASHING & DRYING, IMPOSSIBLE TO CLIMB A FLIGHT OF STAIRS, VERY PAINFUL TO STAND UP FROM A CHAIR. ATTEMPTS HAVE BEEN MADE AND NO FURTHER INFORMATION HAS BEEN MADE AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    372183 ARCOS 18X150MM SPL TPR DIST PROSTHESIS - HIP KWA ZIMMER BIOMET, INC. N/A 186230

    Patients

    Seq Age Sex Outcome Treatment
    1 70 YR Other