BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ARCOS 14X150MM SPL TPR DIST HA X 150MM

    MDR report key: 11384871 · Received February 26, 2021

    Report

    Report Number
    0001825034-2021-00574
    Event Type
    Injury
    Date Received
    February 26, 2021
    Date of Event
    February 18, 2021
    Report Date
    April 15, 2021
    Manufacturer
    ZIMMER BIOMET, INC.
    Product Code
    KWA
    PMA / PMN Number
    NOT CLEARED
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NL
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    THE EVENT WAS CONFIRMED WITH PRODUCT AND RADIOGRAPHS RECEIVED. VISUAL INSPECTION CONFIRMED THE STEM HAS FRACTURED. THE RIBS OF THE STEM HAVE BEEN SCRAPED AND FLATTENED. THE POROUS COATING IS COVERED IN FOREIGN MATERIAL. THE DISTAL FRACTURE SURFACE WAS TOO DAMAGED FOR OPTICAL ANALYSIS. THE PROXIMAL FRACTURE SURFACE SUGGESTS A FATIGUE FRACTURE CULMINATING IN OVERLOAD AS EVIDENCED BY THE PRESENCE OF BEACH MARKS FOLLOWED BY RIVER LINES (INDICATING THE CRACK EXIT SIDE). THE FRACTURE INITIATED ON THE LATERAL SIDE OF THE STEM. HANDHELD XRF ANALYSIS COULD NOT BE PERFORMED ON THIS DEVICE DUE TO NO FLAT SURFACE LARGE ENOUGH TO COVER THE APERTURE. THEREFORE, MATERIAL COMPOSITION COULD NOT BE CONFIRMED. REVIEW OF THE RADIOGRAPHS IDENTIFIED A FRACTURE OF THE RIGHT HIP ARTHROPLASTY STEM WHICH IS DISPLACED AND OVERRIDING WITH FRACTURE OF THE PROXIMAL FEMORAL DIAPHYSIS. THERE IS NO DISLOCATION. REVIEW OF THE DEVICE HISTORY RECORD IDENTIFIED NO DEVIATIONS OR ANOMALIES DURING MANUFACTURING. A DEFINITIVE ROOT CAUSE CANNOT BE DETERMINED. 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 · 0

    NO FURTHER EVENT INFORMATION AVAILABLE AT THE TIME OF THIS REPORT.

    Additional Manufacturer Narrative · 1

    (B)(4). UNKNOWN DAY IN (B)(6) 2014. CONCOMITANT MEDICAL DEVICES: CATALOG#: 22-301300 ARCOS CON SZ A STD 50MM HA 0MM SZ A LOT#: 210390. FOREIGN: (B)(6). 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. CUSTOMER HAS INDICATED THAT THE PRODUCT IS IN PROCESS OF BEING RETURNED TO ZIMMER BIOMET FOR INVESTIGATION. ONCE THE INVESTIGATION HAS BEEN COMPLETED, A FOLLOW-UP MDR WILL BE SUBMITTED. MULTIPLE MDR REPORTS WERE FILED FOR THIS EVENT, PLEASE SEE ASSOCIATED REPORTS: 0001825034-2021-00576.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT UNDERWENT A REVISION PROCEDURE APPROXIMATELY 6 YEARS AND 3 MONTHS POST IMPLANTATION DUE TO FRACTURE OF THE ARCOS STEM. ATTEMPTS HAVE BEEN MADE AND ADDITIONAL INFORMATION ON THE REPORTED EVENT IS UNAVAILABLE AT THIS TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    283520 ARCOS 14X150MM SPL TPR DIST HA X 150MM PROSTHESIS, HIP KWA ZIMMER BIOMET, INC. N/A 737850

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R