BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ARCOS 15X190MM SPL TPR DIST

    MDR report key: 7150928 · Received December 28, 2017

    Report

    Report Number
    0001825034-2017-11435
    Event Type
    Injury
    Date Received
    December 28, 2017
    Date of Event
    June 19, 2015
    Report Date
    August 6, 2018
    Manufacturer
    ZIMMER BIOMET, INC.
    Product Code
    KWA
    PMA / PMN Number
    PK090757
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UT, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE FOLLOW UP REPORT IS SUBMITTED TO RELAY ADDITIONAL INFORMATION RECEIVED. THE COMPLAINT IS CONFIRMED BASED ON THE X-RAYS THAT WERE PROVIDED. FEMORAL STEM IS IN PLACE WITH 2 PROXIMAL CERCLAGE WIRES AND SIGNIFICANT RADIOLUCENCY SURROUNDING THE FEMORAL STEM THROUGHOUT ITS COURSE. REVIEW OF THE DEVICE HISTORY RECORDS FOR REPORTED COMPONENTS IDENTIFIED NO DEVIATIONS OR ANOMALIES THAT COULD CONTRIBUTE TO THE REPORTED EVENT. A DEFINITIVE ROOT CAUSE CANNOT BE DETERMINED WITH THE INFORMATION 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.

    Additional Manufacturer Narrative · 1

    THE FOLLOW UP REPORT IS SUBMITTED TO RELAY CORRECTED / ADDITIONAL INFORMATION: CONCOMITANT MEDICAL PRODUCTS: 11-301303, ARCOS CON SZ C STD 60MM, 163470; S001140, SELEX/MAGNUM MOD HD 40MM STD, 626430. A FOLLOW UP REPORT WILL BE SUBMITTED ONCE THE INVESTIGATION IS COMPLETED: 0001825034-2018-00950.

    Additional Manufacturer Narrative · 1

    CMP-(B)(4). DATE OF EVENT - MANUSCRIPT WAS WRITTEN IN 2017. CONCOMITANT MEDICAL PRODUCTS: UNKNOWN, UNKNOWN ARCOS CONE BODY, UNKNOWN. UNKNOWN, UNKNOWN ARCOS PROXIMAL STEM, UNKNOWN. UNKNOWN, UNKNOWN HEAD, UNKNOWN. UNKNOWN, UNKNOWN LINER, UNKNOWN. UNKNOWN, UNKNOWN CUP, UNKNOWN. REPORT SOURCE, LITERATURE - PELT, C.E. ET AL (2017). REVIEW OF A MODERN MODULAR FEMORAL REVISION STEM IN REVISION TOTAL HIP ARTHROPLASTY. UNPUBLISHED MANUSCRIPT, THE UNIVERSITY OF UTAH DEPARTMENT OF ORTHOPAEDICS, SALT LAKE CITY, UT. REPORTED EVENT WAS UNABLE TO BE CONFIRMED DUE TO LIMITED INFORMATION RECEIVED FROM THE CUSTOMER. DEVICE HISTORY RECORD (DHR) REVIEW WAS UNABLE TO BE PERFORMED AS THE LOT NUMBER OF THE DEVICE INVOLVED IN THE EVENT IS UNKNOWN. ROOT CAUSE WAS UNABLE TO 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. PRODUCT LOCATION UNKNOWN.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT FEMORAL RADIOLUCENT LINES WERE FOUND ON THE LEFT HIP AFTER 3 YEARS 4 MONTH OF POST OP REVISION SURGERY. ATTEMPTS WERE MADE TO REQUEST ADDITIONAL INFORMATION, HOWEVER THERE IS NO ADDITIONAL INFORMATION AT THIS TIME.

    Description of Event or Problem · 1

    IT WAS REPORTED IN A JOURNAL ARTICLE THAT ONE HIP DEMONSTRATED RADIOLUCENCY IN GRUEN ZONES TWO, FIVE, AND SIX. ATTEMPTS HAVE BEEN MADE AND ADDITIONAL INFORMATION ON THE REPORTED EVENT IS UNAVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    930392 ARCOS 15X190MM SPL TPR DIST PROSTHEIS,HIP KWA ZIMMER BIOMET, INC. N/A 532700

    Patients

    Seq Age Sex Outcome Treatment
    1 62 YR Hospitalization| O