BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ARTHROSURFACE TOEMOTION

    MDR report key: 7911839 · Received September 26, 2018

    Report

    Report Number
    3004154314-2018-00016
    Event Type
    Malfunction
    Date Received
    September 26, 2018
    Report Date
    August 26, 2018
    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

    FROM THE RADIOGRAPHS PROVIDED BY THE PATIENT, LUCENCY WAS NOTED AROUND THE PHALANGEAL IMPLANT INDICATING LOOSENING. THE CAUSE FOR REPORTED ISSUE IS UNKNOWN. THE DEVICE IS UNABLE TO BE RETURNED FOR INVESTIGATION AS IT REMAINS IMPLANTED IN THE PATIENT. THE DEVICE HISTORY RECORDS OF THE IMPLANT LOTS IN QUESTION WERE REVIEWED AND NOTED THAT EACH LOT WAS BUILT TO ESTABLISHED SPECIFICATIONS. THE NON-CONFORMING PARTS WERE APPROPRIATELY IDENTIFIED AND SEGREGATED ACCORDINGLY. 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. PER INITIAL INFORMATION, THE PATIENT IS CURRENTLY PLANNING ON A REVISION TO A FUSION. THE PATIENT HAS SINCE NOT RESPONDED TO FOLLOW-UP ATTEMPTS. SHOULD ARTHROSURFACE RECEIVE ANY FURTHER INFORMATION REGARDING THIS EVENT IN FUTURE, IT WILL BE DOCUMENTED AND REPORTED ACCORDINGLY THROUGH A SUPPLEMENTAL MDR. BELOW IS THE INFORMATION RELATED TO THE IMPLANTED DEVICE. PART # 9P15-PB01-W , LOT # 75GF0711, MFG. DATE: 08/10/2016, EXP. DATE: 08/10/2023; PART # 9P15-S180-W , LOT # 75HF0209, MFG. DATE: 08/08/2016 , EXP. DATE: 08/08/2021.

    Description of Event or Problem · 1

    AN ARTHROSURFACE REGIONAL MANAGER WAS CONTACTED BY A TOEMOTION PATIENT WHO IS SEEKING REFERRAL SURGEON INFORMATION. IT WAS LEARNED THAT THE PATIENT HAS LUCENCY AROUND THE IMPLANT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    751986 ARTHROSURFACE TOEMOTION ARTHROSURFACE® TOTAL TOE - PROXIMAL PHALANX IMPLANT LZJ ARTHROSURFACE, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 Other