BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ARTHROSURFACE TOEMOTION

    MDR report key: 7927315 · Received October 2, 2018

    Report

    Report Number
    3004154314-2018-00017
    Event Type
    Injury
    Date Received
    October 2, 2018
    Report Date
    September 3, 2018
    Manufacturer
    ARTHROSURFACE, INC.
    Product Code
    LZJ
    PMA / PMN Number
    K132496
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 1

    THE PATIENT RECEIVED TOE-MOTION IMPLANT IN (B)(6) 2017. PER THE REP WHO ATTENDED THE REVISION CASE, THE REPORTED PAIN, SWELLING AND LOSS OF RANGE OF MOTION WERE ATTRIBUTED TO THE LOOSENING OF PHALANGEAL COMPONENT. ROOT CAUSE WAS UNABLE TO BE DETERMINED AS THE DEVICE WAS NOT RETURNED. THE DEVICE HISTORY RECORDS (DHRS) OF THE IMPLANT LOTS IN QUESTIONS WERE REVIEWED AND NOTED THAT ALL PARTS WERE BUILT TO SPECIFICATION. NON-CONFORMING PARTS HAVE BEEN PROPERLY IDENTIFIED AND SEGREGATED DURING THE INSPECTION PROCESS. THE INSTRUCTIONS FOR USE (IFU) DOCUMENT STATES THAT REPORTED EVENTS CAN OCCUR, AND ALL RISKS ARE ADDRESSED IN THE RISK DOCUMENTATION AS A APART OF THE DESIGN CONTROL. 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. IF ADDITIONAL RELEVANT INFORMATION IS RECEIVED, INFORMATION WILL BE REVIEWED AND COMPLAINT FILE WILL BE AMENDED ACCORDINGLY. THE PATIENT WAS REVISED TO A FUSION AND ALL ARTHROSURFACE DEVICES HAVE BEEN EXPLANTED. FOLLOWING IS THE INFORMATION OF IMPLANTS IN QUESTION. PART # 9P15-S180-W, LOT # 75AF2810, MFG. DATE: 05/06/2016, EXP. DATE: 05/06/2021. PART # 9P15-PB01-W, LOT # 75CF3110, MFG. DATE: 05/11/2016, EXP. DATE: 05/06/2023.

    Description of Event or Problem · 1

    A TOTAL TOE PATIENT WAS REVISED DUE TO PAIN, SWELLING AND LOSS OF RANGE OF MOTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    768897 ARTHROSURFACE TOEMOTION ARTHROSURFACE® TOTAL TOE - PROXIMAL PHALANX IMPLANT LZJ ARTHROSURFACE, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 Other