BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NUGRIP GENERIC

    MDR report key: 8875566 · Received August 8, 2019

    Report

    Report Number
    1651501-2019-00028
    Event Type
    Injury
    Date Received
    August 8, 2019
    Report Date
    July 17, 2019
    Manufacturer
    ASCENSION ORTHOPEDICS
    Product Code
    KYI
    PMA / PMN Number
    K112278
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    THE DEVICE WAS NOT RETURNED FOR EVALUATION THEREFORE THE FAILURE ANALYSIS TO IDENTIFY ROOT CAUSE TO THE END USERS EXPERIENCE COULD NOT BE DETERMINED. THE DHR REVIEW CANNOT BE PERFORM AT THIS TIME.

    Additional Manufacturer Narrative · 1

    THE DEVICE INVOLVED IN THE REPORTED INCIDENT IS NOT AVAILABLE FOR EVALUATION. AN INVESTIGATION HAS BEEN INITIATED BASED ON THE REPORTED INFORMATION. DOI 10.1007/S00256-017-2648-Z.

    Description of Event or Problem · 1

    SKELETAL RADIOL (2017) PUBLISHED: "RADIOGRAPHIC INTERPRETATION OF CARPOMETACARPAL ARTHROPLASTY: CORRELATION BETWEEN RADIOGRAPHIC LOOSENING AND CLINICAL OUTCOME". PURPOSE: THE PURPOSE OF THIS CASE SERIES WAS TO ASSESS THE RADIOGRAPHIC APPEARANCE AND INTERPRETATION OF LOOSENING IN PATIENTS FOLLOWING FIRST CARPOMETACARPAL JOINT PYROHEMISPHERE ARTHROPLASTY. METHODS: A RETROSPECTIVE REVIEW OVER A 6-YEAR PERIOD WAS PERFORMED IDENTIFYING PATIENTS WITH FIRST CARPOMETACARPAL PYROHEMISPHERE IMPLANTS. ALL POSTOPERATIVE RADIOGRAPHS WERE REVIEWED AND COMPARED WITH CLINICAL INFORMATION. LOOSENING WAS DEFINED AS GREATER THAN 1 MM OF PERIPROSTHETIC LUCENCY OR INCREASING LUCENCY ON SERIAL STUDIES. ADVERSE CLINICAL OUTCOME WAS DEFINED AS INFECTION, COMPLEX REGIONAL PAIN SYNDROME, SUBLUXATION OR AN INABILITY TO RETURN TO ACTIVITIES OF DAILY LIVING. STATISTICAL ANALYSIS INCLUDED COHEN¿S KAPPA COEFFICIENT TO MEASURE INTER-READER AGREEMENT FOR RADIOGRAPHIC INTERPRETATION AND THE AGREEMENT BETWEEN RADIOGRAPHIC LOOSENING AND AN UNDESIRED OR ADVERSE CLINICAL OUTCOME. RESULTS: THIRTY-ONE IMPLANTS IN 26 PATIENTS WERE REVIEWED. A TOTAL OF 73 POSTOPERATIVE RADIOGRAPHS WERE REVIEWED. THE MEAN AGE OF THE STUDY SUBJECTS WAS 58 YEARS. THE MEAN RADIOGRAPHIC FOLLOW-UP WAS 13 MONTHS (RANGE: 1¿56). ALL ARTHROPLASTIES WERE PERFORMED FOR OSTEOARTHRITIS. ONLY ONE REPEAT SURGERY WAS PERFORMED. ADVERSE EVENT: FIVE PATIENTS IN THE STUDY, FOR A TOTAL OF 6 IMPLANTS, COMPLAINED OF ADVERSE CLINICAL OUTCOMES: ONE (1) - POSTOPERATIVE INFECTION, ONE (1) - COMPLEX REGIONAL PAIN SYNDROME, TWO (2) - SUBLUXATION - ONE HAD REVISION SURGERY, TWO (2) - UNABLE TO RETURN TO ACTIVITIES OF DAILY LIVING. CONCLUSIONS: ALTHOUGH RADIOGRAPHY MAY BE USEFUL IN THE CORRECT CLINICAL CONTEXT, IT SHOULD NOT BE UTILIZED AS THE SOLE PREDICTOR OF ADVERSE CLINICAL OUTCOMES FOLLOWING CARPOMETACARPAL ARTHROPLASTY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    670642 NUGRIP GENERIC NUGRIP KYI ASCENSION ORTHOPEDICS

    Patients

    Seq Age Sex Outcome Treatment
    1