BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ARCOS TROCH BUTTON 25MM

    MDR report key: 7267656 · Received February 13, 2018

    Report

    Report Number
    0001825034-2018-00899
    Event Type
    Injury
    Date Received
    February 13, 2018
    Date of Event
    May 26, 2015
    Report Date
    October 29, 2018
    Manufacturer
    ZIMMER BIOMET, INC.
    Product Code
    LPH
    PMA / PMN Number
    PK130063
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UT, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    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.

    Description of Event or Problem · 0

    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.

    Additional Manufacturer Narrative · 1

    (B)(4). 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,  11-302124 ARCOS LATERAL TROCH BOLT 24MM 574800,  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 MDR REPORT WILL BE SUBMITTED ONCE THE INVESTIGATION IS COMPLETED. MULTIPLE MDR REPORTS WERE FILED FOR THIS EVENT, PLEASE SEE ASSOCIATED REPORTS: 0001825034-2017-11405, 0001825034-2017-11404. INVESTIGATION IN PROGRESS.

    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.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    110690 ARCOS TROCH BUTTON 25MM PROSTHESIS, HIP LPH ZIMMER BIOMET, INC. N/A 353420

    Patients

    Seq Age Sex Outcome Treatment
    1 46 YR Hospitalization| R