BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FGT IMPLANT SIZE 20

    MDR report key: 10480223 · Received September 1, 2020

    Report

    Report Number
    1651501-2020-00016
    Event Type
    Malfunction
    Date Received
    September 1, 2020
    Date of Event
    August 5, 2020
    Report Date
    April 21, 2021
    Manufacturer
    ASCENSION ORTHOPEDICS
    Product Code
    KWH
    PMA / PMN Number
    K981194
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    UPDATED FIELDS: D4, D9, G3, G6, H2, H3, H6, H10. THE FOLLOWING WAS NOT INCLUDED IN FOLLOW UP #1: PRODUCT NOT RECEIVED FOR EVALUATION, BUT PHOTOGRAPHS WERE PROVIDED. PHOTOGRAPHS OF THE EXPLANTED DEVICE SHOW CRACKING AT THE DEVICE JOINT WHEN THE DEVICE IS FLEXED. THE FAILURE IS CONFIRMED.

    Additional Manufacturer Narrative · 0

    UPDATED FIELDS - D10, G4, G7, H2, H3, H6, H10. UDI: (B)(4). ADDITIONAL INFORMATION RECEIVED: PATIENT HAD PREVIOUS CHEILECTOMY AND THAT THERE WERE NO TRAUMATIC OR CONTRIBUTING EVENTS PRIOR TO THE DISCOVERY OF THE ISSUE. THE IMPLANT WAS REMOVED BECAUSE IT WAS CRACKED AND DAMAGED, REPLACED BY A NEW FGT IMPLANT. THE PATIENT HAVE EXPERIENCED GENERAL DISCOMFORT DUE TO IMPLANT FAILURE. THE IMPLANT WAS NOT RETURNED FOR EVALUATION AND LOT NUMBER INFORMATION HAS NOT BEEN PROVIDED; THEREFORE, AN EVALUATION OF THE DEVICE COULD NOT BE PERFORMED, AND MANUFACTURING RECORDS COULD NOT BE REVIEWED. THE CAUSE(S) OF THE DIFFICULTY REPORTED BY THE CUSTOMER COULD NOT BE DETERMINED. IF ADDITIONAL RELEVANT INFORMATION BECOMES AVAILABLE IN THE FUTURE, THIS COMPLAINT WILL BE REOPENED, AND THE RESPECTIVE EVALUATION PERFORMED. TRENDS WILL BE MONITORED FOR THIS AND SIMILAR ISSUES. AT PRESENT, WE CONSIDER THIS COMPLAINT TO BE CLOSED.

    Description of Event or Problem · 0

    N/A.

    Description of Event or Problem · 0

    N/A.

    Additional Manufacturer Narrative · 1

    ATTEMPTS ARE BEING MADE TO OBTAIN ADDITIONAL INFORMATION. UPON COMPLETION OF THE INVESTIGATION, A FOLLOW-UP REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 1

    A PHYSICIAN REPORTED A TOE JOINT REPLACEMENT IMPLANT ¿CRACK¿: THE IMPLANT WAS PLACED ON RIGHT GREAT TOE ON (B)(6) 2020. PATIENT HAD A CHEILECTOMY BEFORE THIS SURGERY. THE IMPLANT WAS REMOVED ON (B)(6) 2020 AND IT HAD A CRACK/CUT THROUGH SILICONE PORTION OF FLEXIBLE JOINT. SURGEON BELIEVES REMAINING BONE SPURS DAMAGED THE IMPLANT AND CAUSED IT TO FAIL. HE IS AN EXPERIENCED SURGEON ON THIS PRODUCT AND HAS NEVER SEEN THIS TYPE OF RESULT. HE BELIEVES THE ISSUE WAS BIOLOGIC AND NOT THE RESULT OF A FAULTY IMPLANT. HE HAS NO ISSUES WITH THE IMPLANT¿S PERFORMANCE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    942051 FGT IMPLANT SIZE 20 TOE JOINT REPLACEMENT KWH ASCENSION ORTHOPEDICS CT0115126

    Patients

    Seq Age Sex Outcome Treatment
    1 50 YR