BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ARCOS LATERAL TROCH BOLT 24MM

    MDR report key: 7151009 · Received December 28, 2017

    Report

    Report Number
    0001825034-2017-11405
    Event Type
    Injury
    Date Received
    December 28, 2017
    Date of Event
    May 26, 2015
    Report Date
    October 29, 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

    THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. REPORTED EVENT WAS CONFIRMED BY REVIEW OF MEDICAL RECORDS. REVIEW OF THE DEVICE HISTORY RECORDS FOR REPORTED COMPONENTS IDENTIFIED NO DEVIATIONS OR ANOMALIES THAT COULD CONTRIBUTE TO THE REPORTED EVENT. 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.

    Additional Manufacturer Narrative · 1

    THIS FOLLOW UP REPORT IS BEING FILED TO RELAY ADDITIONAL INFORMATION. CONCOMITANT MEDICAL PRODUCTS: 103535,  TI LOW PROFILE SCREW 6.5X40MM, 713220;  11-300912, ARCOS 12X190MM SPL TPR DIST, 864850;  PT-106054, REGEN/RNGLC+ MULTI 54MM SZ 23, 641620;  11-302109, ARCOS TROCH BUTTON 25MM, 353420;  11-302128, ARCOS LATERAL TROCH BOLT, 28MM 138820;  103532 , TI LOW PROFILE SCREW 6.5X25MM, 635030;  EP-108223, E-POLY 36MM +3 MAXROM LNR, SZ23 619300;  11-301341, ARCOS CON SZ A STD 80MM, 476440;  11-363666, 36MM COCR MOD HD +12MM, 192930.  A FOLLOW UP REPORT WILL BE SUBMITTED AFTER INVESTIGATION IS COMPLETED. MULTIPLE MDR REPORTS WERE FILED FOR THIS EVENT, PLEASE SEE ASSOCIATED REPORTS: 0001825034-2017-11404; 0001825034-2018-00899. INVESTIGATION IN PROGRESS.

    Additional Manufacturer Narrative · 1

    (B)(4). DATE OF EVENT - MANUSCRIPT WAS WRITTEN IN 2017. CONCOMITANT PRODUCTS: UNKNOWN, UNKNOWN ARCOS DISTAL 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. MULTIPLE MDR REPORTS WERE FILED FOR THIS EVENT, PLEASE SEE ASSOCIATED REPORTS: 0001825034 - 2017 - 11404. PRODUCT LOCATION UNKNOWN

    Description of Event or Problem · 1

    IT WAS REPORTED PATIENT UNDERWENT A RIGHT HIP REVISION DUE TO NON-UNION OF A PERI-PROSTHETIC FRACTURE APPROXIMATELY ELEVEN (11) MONTHS POST-IMPLANTATION. ABDUCTION WEAKNESS LEADING TO PAIN WAS ALSO REPORTED. DURING THE REVISION, IT WAS NOTED THE TROCHANTER BOLT WAS LOOSE. THE BOLT WAS REMOVED AND PLATE AND SCREWS WERE IMPLANTED TO FIX THE FRACTURE. NO FURTHER INFORMATION HAS BEEN PROVIDED.

    Description of Event or Problem · 1

    IT WAS REPORTED PATIENT UNDERWENT RIGHT HIP REVISION DUE TO NON-UNION OF A PERIPROSTHETIC FRACTURE NINE MONTHS POST-IMPLANTATION. DURING THE REVISION, IT WAS NOTED THE TROCHANTER BOLT WAS LOOSE. THE BOLT WAS REMOVED AND PLATE AND SCREWS WERE IMPLANTED TO FIX THE FRACTURE. NO FURTHER INFORMATION HAS BEEN PROVIDED.

    Description of Event or Problem · 1

    IT WAS REPORTED IN A JOURNAL ARTICLE THAT ONE PATIENT WAS REVISED DUE TO NON-UNION OF A PERIPROSTHETIC FRACTURE. ATTEMPTS HAVE BEEN MADE AND ADDITIONAL INFORMATION ON THE REPORTED EVENT IS UNAVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    931661 ARCOS LATERAL TROCH BOLT 24MM PROSTHESIS, HIP KWA ZIMMER BIOMET, INC. N/A 574800

    Patients

    Seq Age Sex Outcome Treatment
    1 46 YR Hospitalization| R