BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ARTHROSURFACE TOEMOTION

    MDR report key: 12050320 · Received June 23, 2021

    Report

    Report Number
    3004154314-2021-00003
    Event Type
    Malfunction
    Date Received
    June 23, 2021
    Report Date
    May 27, 2021
    Manufacturer
    ARTHROSURFACE, INC.
    Product Code
    LZJ
    PMA / PMN Number
    K132496
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 1

    THE REASON FOR REPORTED PAIN COULD BE DUE TO LOOSENED PHALANGEAL COMPONENT THAT WAS NOTED DURING THE REVISION SURGERY. ROOT CAUSE FOR LOOSENING WAS UNABLE TO BE DETERMINED AS THE DEVICE WAS NOT RETURNED AND NECESSARY INFORMATION TO ADEQUATELY INVESTIGATE THE REPORTED EVENT WAS NOT PROVIDED. SINCE NO PART AND LOT INFORMATION WAS PROVIDED, REVIEW OF THE DEVICE HISTORY RECORDS (DHRS) OF DEVICES IN QUESTION CANNOT BE CONDUCTED. THE INSTRUCTIONS FOR USE (IFU) DOCUMENT STATES THAT THIS TYPE OF EVENT CAN OCCUR, AND ALL RISKS ARE ADDRESSED IN THE RISK DOCUMENTATION. A VALID ROOT CAUSE CANNOT BE ESTABLISHED BASED ON AVAILABLE INFORMATION. SEVERAL FACTORS SUCH AS STRESS/ PHYSICAL LOADS ON THE IMPLANTS, VASCULARITY OF THE IMPLANTATION SITE, SURGICAL TECHNIQUES EMPLOYED DURING IMPLANTATION, PATIENT FACTORS (SUCH AS AGE, CURRENT STATE OF THE IMMUNE SYSTEM, BONE QUALITY, AND SENSITIVITY TO DEVICE MATERIALS), AND PATIENT POST-OP COMPLIANCE TO REHABILITATION PROCEDURES ETC. CAN HAVE IMPACT ON THE FUNCTIONAL EFFECTIVENESS OF THE IMPLANTED DEVICES. THE IMPLANT MATERIALS AND COMBINATIONS HAVE DECADES OF HISTORY FOR USE IN JOINT REPLACEMENT APPLICATIONS. ALSO, THE IMPLANT MATERIALS HAVE BEEN EVALUATED FOR BIOCOMPATIBILITY TO DEMONSTRATE SAFETY FOR INTENDED USE. IF ADDITIONAL RELEVANT INFORMATION IS RECEIVED, A FOLLOW-UP REPORT WILL BE SUBMITTED. THE PATIENT WAS REVISED TO A FUSION AND ALL TOEMOTION COMPONENTS HAVE BEEN EXPLANTED. SHOULD ARTHROSURFACE RECEIVE ANY FURTHER INFORMATION REGARDING THIS EVENT IN FUTURE, IT WILL BE DOCUMENTED AND REPORTED ACCORDINGLY THROUGH A SUPPLEMENTAL MDR.

    Description of Event or Problem · 1

    TOEMOTION PATIENT REVISED DUE TO PAIN. THE REP INDICATED THAT THE PHALANGEAL COMPONENT WAS LOOSE AND A VOID WAS NOTED SURROUNDING THE IMPLANT UNDER X-RAY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    949662 ARTHROSURFACE TOEMOTION ARTHROSURFACE® TOTAL TOE - PROXIMAL PHALANX IMPLANT LZJ ARTHROSURFACE, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 Other