BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKN FREEDOM IMPL

    MDR report key: 16889120 · Received May 8, 2023

    Report

    Report Number
    3002788818-2023-00034
    Event Type
    Injury
    Date Received
    May 8, 2023
    Date of Event
    April 11, 2023
    Report Date
    June 12, 2023
    Manufacturer
    ASCENSION ORTHOPEDICS, INC.
    Product Code
    KWM
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    SECTION H10: THE PRODUCT HAS NOT BEEN RETURNED TO THE AUS SITE FOR EVALUATION AND PHOTOGRAPHS WERE NOT PROVIDED, SO THE REPORTED EVENT COULD NOT BE CONFIRMED. THE FOLLOWING INVESTIGATIVE ACTIONS WERE PERFORMED: COMPLAINT HISTORY REVIEW: THE COMPLAINT HISTORY REVIEW IDENTIFIED NO SIMILAR REPORTED EVENTS FOR THIS DEVICE. NO ADVERSE TREND WAS IDENTIFIED. FUTURE COMPLAINTS FOR THIS FAILURE MODE WILL CONTINUE TO BE MONITORED AND INVESTIGATED AS REQUIRED. RISK MANAGEMENT REVIEW (DEVICE): IDENTIFIED NO ISSUES WHICH COULD HAVE CAUSED OR CONTRIBUTED TO THE REPORTED EVENT. THE FAILURE MODE WAS PREVIOUSLY IDENTIFIED BY THE RISK MANAGEMENT FILE AND THE ANTICIPATED RISK LEVEL IS ACCEPTABLE. CAPA/NC/PRA/HHE/FIELD ACTION REVIEW: IDENTIFIED NO PREVIOUS EVENTS OR ISSUES WHICH COULD HAVE CAUSED OR CONTRIBUTED TO THE REPORTED EVENT. ASSESSMENT OF HISTORICAL ESCALATED CASES CONCLUDED THAT THERE ARE NO PRIOR ACTIONS RELATED TO THIS DEVICE AND FAILURE MODE. DEVICE LABELING/IFU REVIEW: IDENTIFIED NO ISSUES WHICH COULD HAVE CAUSED OR CONTRIBUTED TO THE REPORTED EVENT. THIS REVIEW DETERMINED THAT THE DEVICE MET LABELING REQUIREMENTS UPON RELEASE FOR DISTRIBUTION. PRODUCT PRINTS/SPECIFICATIONS/PROCEDURE REVIEW: IDENTIFIED NO ISSUES WHICH COULD HAVE CAUSED OR CONTRIBUTED TO THE REPORTED EVENT. THIS REVIEW DETERMINED THAT THE DEVICE MET PRODUCT SPECIFICATIONS UPON RELEASE FOR DISTRIBUTION. CLINICAL/MEDICAL EVALUATION: THE REQUESTED CLINICAL DOCUMENTATION HAS NOT BEEN PROVIDED FOR EVALUATION. THEREFORE, THERE WERE NO CLINICAL FACTORS FOUND WHICH WOULD HAVE CAUSED OR CONTRIBUTED TO THE REPORTED EVENT. THE PATIENT IMPACT BEYOND THAT WHICH HAS BEEN ALREADY REPORTED COULD NOT BE CONFIRMED NOR CONCLUDED. DHR/BATCH RECORD REVIEW: AS THE PRODUCT LOT NUMBER WAS NOT REPORTED, THE DHR/BATCH RECORD REVIEW COULD NOT BE COMPLETED. VISUAL INSPECTION: VISUAL INSPECTION WAS UNABLE TO BE PERFORMED BECAUSE THE DEVICE HAS NOT BEEN RECEIVED FOR EVALUATION. THE COMPLAINT ALLEGES THAT REVISION SURGERY WAS REQUIRED. AS THE DEVICE WAS NOT RETURNED FOR EVALUATION, A DETERMINATION OF WHETHER THE DEVICE CONTRIBUTED TO THE REPORTED EVENT COULD NOT BE MADE. AS THE PRODUCT LOT NUMBER WAS NOT REPORTED, A DETERMINATION OF WHETHER THE DEVICE MET MANUFACTURING SPECIFICATIONS COULD NOT BE MADE. AS THE DEVICE HAS NOT BEEN RETURNED FOR EVALUATION, A DEFINITIVE ROOT CAUSE FOR THE REPORTED EVENT COULD NOT BE DETERMINED. THE FREEDOM WRIST TOTAL WRIST ARTHROPLASTY SYSTEM CONSISTS OF THREE STERILE IMPLANTABLE COMPONENTS: THE RADIAL IMPLANT, THE CARPAL PLATE, AND THE CARPAL POLY. THE RADIAL IMPLANT AND THE CARPAL PLATE METAL IMPLANTS ARE SECURED IN PLACE WITH SCREWS. THE COMPLAINT DESCRIPTION DOES NOT PROVIDE ENOUGH INFORMATION TO DETERMINE THE MANNER IN WHICH THE DEVICE FAILED AND REQUIRED REVISION SURGERY. THEREFORE, NO CONCLUSIONS ABOUT PROBABLE OR CONTRIBUTING CAUSES COULD BE MADE. BASED ON THIS INVESTIGATION, THE NEED FOR CORRECTIVE ACTION IS NOT INDICATED AS NO NON-CONFORMANCES NOR MANUFACTURING DEFICIENCIES WERE IDENTIFIED AND THE RISK LEVEL IS ACCEPTABLE. IF ADDITIONAL INFORMATION IS LATER RECEIVED, THE COMPLAINT MAY BE REOPENED. NO FURTHER INVESTIGATION IS WARRANTED FOR THIS COMPLAINT, THOUGH FUTURE COMPLAINTS WILL BE MONITORED AND INVESTIGATED AS REQUIRED. INTERNAL COMPLAINT REFERENCE NUMBER: (B)(4).

    Additional Manufacturer Narrative · 0

    INTERNAL COMPLAINT REFERENCE: (B)(4).

    Description of Event or Problem · 0

    IT WAS REPORTED THAT, AFTER UNKNOWN SURGERY HAD BEEN PERFORMED, THE PATIENT EXPERIENCED AN UNKNOWN FAILURE. THIS ADVERSE EVENT WILL BE SOLVED THROUGH A REVISION SURGERY. PATIENT STATUS IS UNKNOWN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1902420 UNKN FREEDOM IMPL PROSTHESIS, WRIST, SEMI-CONSTRAINED KWM ASCENSION ORTHOPEDICS, INC. UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown