BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ARTHROSURFACE TOEMOTION

    MDR report key: 11759824 · Received May 3, 2021

    Report

    Report Number
    3004154314-2021-00002
    Event Type
    Injury
    Date Received
    May 3, 2021
    Report Date
    April 13, 2021
    Manufacturer
    ARTHROSURFACE, INC.
    Product Code
    LZJ
    PMA / PMN Number
    K132496
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 1

    THE ROOT CAUSE WAS UNABLE TO BE DETERMINED AS 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. 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 PURPOSES. ARTHROSURFACE REACHED OUT TO THE PATIENT AND PROVIDED REFERRAL SURGEONS THAT HAVE EXPERIENCE WITH TOEMOTION IMPLANTS FOR FURTHER EVALUATION OF HER TOE JOINT. IF ADDITIONAL RELEVANT INFORMATION IS RECEIVED, INFORMATION WILL BE REVIEWED, AND COMPLAINT FILE WILL BE AMENDED ACCORDINGLY.

    Description of Event or Problem · 1

    PATIENT REACHED OUT TO ARTHROSURFACE VIA WEBSITE TO REPORT JOINT PAIN AND STIFFNESS SHE IS EXPERIENCING SINCE RECEIVING THE TOEMOTION IMPLANT IN (B)(6) 2019. THERE WAS RANGE OF MOTION INITIALLY BUT THE JOINT REMAINED STIFF MOST OF THE TIME. PHYSICAL THERAPY AND BENDING OF THE JOINT OF THE DID NOT HELP. PATIENT WAS TOLD BY HER CURRENT PODIATRIST THAT THE JOINT FAILED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    658331 ARTHROSURFACE TOEMOTION ARTHROSURFACE® TOTAL TOE - PROXIMAL PHALANX IMPLANT LZJ ARTHROSURFACE, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 59 YR Other