BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ARCOS CON SZ B STD 60MM

    MDR report key: 7273773 · Received February 15, 2018

    Report

    Report Number
    0001825034-2018-00998
    Event Type
    Malfunction
    Date Received
    February 15, 2018
    Date of Event
    September 7, 2016
    Report Date
    April 20, 2018
    Manufacturer
    ZIMMER BIOMET, INC.
    Product Code
    KWA
    PMA / PMN Number
    PK090757
    Removal / Correction Number
    N/A
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UT, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    REPORTED EVENT WAS CONFIRMED BY REVIEW OF X-RAYS PROVIDED WHICH INDICATED POSSIBLE LUCENCY ALONG THE ENTIRE FEMORAL COMPONENT AT THE BONE CEMENT INTERFACE AS WELL AS SURROUNDING THE ACETABULAR CUP. DHR WAS REVIEWED AND NO DISCREPANCIES WERE FOUND. REVIEW OF THE COMPLAINT HISTORY DETERMINED THAT NO FURTHER ACTION IS REQUIRED. ROOT CAUSE WAS UNABLE TO BE DETERMINED AS THE NECESSARY INFORMATION TO ADEQUATELY INVESTIGATE THE REPORTED EVENT WAS NOT PROVIDED. STRYKER CUP USED WITH BIOMET STEM, HEAD AND TAPER SLEEVE. ZIMMER-BIOMET HAS NOT ASSESSED OR CONFIRMED THE COMPATIBILITY OF THIS COMBINATION OF DEVICES, AND THIS WOULD BE CONSIDERED AN OFF-LABEL USE OF THESE DEVICES. HOWEVER, IT CANNOT BE CONFIRMED THAT THIS INCOMPATIBILITY HAS ANY DEFINITIVE RELATIONSHIP TO THE REPORTED EVENT. A SUMMARY OF THE INVESTIGATION WAS SENT TO THE COMPLAINANT CONVEYING PROPER SURGICAL TECHNIQUE AND USE OF THE DEVICE. 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.

    Additional Manufacturer Narrative · 1

    (B)(6). CONCOMITANT: 11-300815 ARCOS 15X150MM SPL TPR DIST 011370;  650-1055 CER BIOLOXD OPTION HD 28MM 759280;  650-1064 CER OPTION TYPE 1 TPR SLEVE -6 854580.  A FOLLOW UP REPORT WILL BE SUBMITTED ONCE THE INVESTIGATION IS COMPLETED, MULTIPLE MDR REPORTS WERE FILED FOR THIS EVENT, PLEASE SEE ASSOCIATED REPORTS: 0001825034-2018-00999

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE RADIOLUCENCY LINES WERE SEE ON RIGHT HIP AFTER 2 YEARS 1 MONTHS POST REVISION SURGERY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    118274 ARCOS CON SZ B STD 60MM PROSTHESIS, HIP KWA ZIMMER BIOMET, INC. N/A 519670

    Patients

    Seq Age Sex Outcome Treatment
    1 48 YR