BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ARTHROSURFACE TOEMOTION

    MDR report key: 8002702 · Received October 24, 2018

    Report

    Report Number
    3004154314-2018-00019
    Event Type
    Malfunction
    Date Received
    October 24, 2018
    Report Date
    September 25, 2018
    Manufacturer
    ARTHROSURFACE, INC.
    Product Code
    LZJ
    PMA / PMN Number
    K132496
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 1

    THE PATIENT RECEIVED TOEMOTION IMPLANT IN (B)(6) 2015 AND WAS REVISED TO A FUSION IN (B)(6) 2018. THE REASON FOR REPORTED SUBSIDENCE IS UNKNOWN. ACCORDING TO THE REP WHO ATTENDED THE CASE, AN UNKNOWN ORANGE RESIDUE WAS NOTED IN THE PHALANGEAL VOID. RESULTS OF THE CULTURE ARE AWAITED AND THIS REPORT WILL BE SUPPLEMENTED IF THE RESULTS ARE POSITIVE. THE ROOT CAUSE WAS UNABLE TO BE DETERMINED AS THE DEVICE WAS NOT RETURNED. THE DEVICE HISTORY RECORDS (DHRS) OF THE IMPLANT LOTS IN QUESTION 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-A LOT # 75GD0122 MFG. DATE: 07/2014 EXP. DATE: 07/2019, PART # 9P15-PB01-W LOT # 75ID0208 MFG. DATE: 10/2014 EXP. DATE: 10/2019.

    Description of Event or Problem · 1

    ARTHROSURFACE WAS NOTIFIED OF A TOEMOTION REVISION CASE WHERE SUBSIDENCE WAS NOTED SURROUNDING THE PHALANGEAL COMPONENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    840628 ARTHROSURFACE TOEMOTION ARTHROSURFACE® TOTAL TOE - PROXIMAL PHALANX IMPLANT LZJ ARTHROSURFACE, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 Other