BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ARTHROSURFACE TOEMOTION

    MDR report key: 7112663 · Received December 13, 2017

    Report

    Report Number
    3004154314-2017-00024
    Event Type
    Malfunction
    Date Received
    December 13, 2017
    Report Date
    December 7, 2017
    Manufacturer
    ARTHROSURFACE, INC.
    Product Code
    LZJ
    PMA / PMN Number
    K132496
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Additional Manufacturer Narrative · 1

    THERE WAS NO TRAUMA OR INJURY TO THE PATIENT ACCORDING TO REP WHO ATTENDED THE REVISION CASE. ARTHROSURFACE OBTAINED FEEDBACK FROM VARIOUS SURGEONS REGARDING POST-OP IMAGES OF THE IMPLANT. THE IMMEDIATE POST-OP X-RAY WITH A LINEAR OPACITY AROUND THE IMPLANT SUGGESTS A TECHNICAL ERROR PLACING THE TAP TOO DEEP ON BOTH SIDES OF THE MTP JOINT WHICH COULD RESULT IN POOR FIXATION IMMEDIATELY AND ALLOWS DEBRIS TO GET AROUND THE IMPLANT. APART FROM REVIEW OF THE X-RAYS, DEVICE HISTORY RECORDS (DHRS) OF ALL IMPLANT LOTS IN QUESTION WERE REVIEWED AND NOTED THAT ALL PARTS WERE MANUFACTURED TO SPECIFICATION. ADDITIONALLY, PERFORMANCE HISTORY (NUMBER OF CASES RECORDED) OF THE IMPLANT LOTS IN QUESTION WAS REVIEWED AND NOTED THAT NO ISSUES OR COMPLAINTS WERE REPORTED TILL DATE. THE PATIENT IS CURRENTLY REVISED TO AN IMPLANT OF ANOTHER MANUFACTURER AND ALL ARTHROSURFACE COMPONENTS HAVE BEEN EXPLANTED. ARTHROSURFACE WILL CONTINUE TO MONITOR FOR SIMILAR ISSUES. THE MANUFACTURING AND EXPIRATION DATES OF THE PHALANGEAL COMPONENTS IN QUESTION ARE: PART # 9P15-S180-A, LOT # 75AE3004, MFG. DATE: 2015-03, EXP. DATE: 2020-03. PART # 9P15-PB01-A, LOT # 75AE3014, MFG. DATE: 2015-02, EXP. DATE: 2020-02.

    Description of Event or Problem · 1

    ARTHROSURFACE WAS NOTIFIED OF A REVISION CASE WHERE THE PATIENT WAS REVISED DUE TO LOOSENING OF PHALANGEAL IMPLANT AND BONE LOSS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    891321 ARTHROSURFACE TOEMOTION ARTHROSURFACE® TOTAL TOE - PROXIMAL PHALANX IMPLANT LZJ ARTHROSURFACE, INC. 75AE3004 & 75AE3014

    Patients

    Seq Age Sex Outcome Treatment
    1 Other