BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INVISION¿ TOTAL ANKLE SYSTEM

    MDR report key: 15048399 · Received July 18, 2022

    Report

    Report Number
    3010667733-2022-00251
    Event Type
    Injury
    Date Received
    July 18, 2022
    Date of Event
    June 20, 2022
    Report Date
    September 27, 2022
    Manufacturer
    WRIGHT MEDICAL TECHNOLOGY INC
    Product Code
    HSN
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THIS PART IS NOT APPROVED FOR USE IN THE UNITED STATES; HOWEVER A LIKE DEVICE CATALOG 510K # K171067 WAS CLEARED IN THE UNITED STATES. THE REPORTED EVENT COULD NOT BE CONFIRMED SINCE THE DEVICE WAS NOT RETURNED FOR EVALUATION AND NO OTHER EVIDENCES WERE PROVIDED. MORE DETAILED INFORMATION ABOUT THE COMPLAINT EVENT AS WELL AS THE AFFECTED DEVICE MUST BE AVAILABLE IN ORDER TO DETERMINE THE ROOT CAUSE OF THE COMPLAINT EVENT. A REVIEW OF THE DEVICE HISTORY FOR THE REPORTED LOT DID NOT INDICATE ANY ABNORMALITIES. NO CORRECTIVE ACTIONS ARE REQUIRED AT THIS TIME. A REVIEW OF THE LABELING DID NOT INDICATE ANY ABNORMALITIES. NO INDICATIONS OF MATERIAL, MANUFACTURING OR DESIGN RELATED PROBLEMS WERE FOUND DURING THE INVESTIGATION. IF THE DEVICE IS RETURNED OR IF ANY ADDITIONAL INFORMATION IS PROVIDED, THE INVESTIGATION WILL BE REPORTED.

    Additional Manufacturer Narrative · 0

    CORRECTION H6 RESULTS CODE, CONCLUSION CODE. THE REPORTED EVENT COULD BE CONFIRMED SINCE IMAGES OF CT SCANS WERE PROVIDED AND MATCHES THE ALLEGED FAILURE MODE. THERE ARE MANY CLINICAL FACTORS THAT CAN AFFECT THE RESULTS OF ANY SURGERY, SUCH AS SURGICAL TECHNIQUE, PRE-OPERATIVE AND POST-OPERATIVE CARE, THE IMPLANT, PATIENT PATHOLOGY AND DAILY ACTIVITY. A MEDICAL PROFESSIONAL REVIEWED THE RECEIVED INFORMATION AND NOTED THE FOLLOWING: ¿THE BREAKAGE OF A SCREW WAS RELIABLY ASSESSED ON THE MPR OF THE CT-SCAN. POOR BONE QUALITY AND INCOMPLETE SUBTALAR FUSION LED TO LOOSENING AND SUBSIDENCE OF THE TALAR COMPONENT AND UNAVOIDABLE BREAKAGE OF A SCREW. MULTIPLE INTERVENTIONS REFLECTING THE INITIAL COMPLEX HINDFOOT PATHOLOGY RELATE TO THE BONE QUALITY.¿ BASED ON INVESTIGATION, THE ROOT CAUSE WAS ATTRIBUTED TO A PATIENT FACTOR RELATED ISSUE. AS NOTED BY A MEDICAL PROFESSIONAL, THE FAILURE WAS CAUSED BY POOR BONE QUALITY AND INCOMPLETE SUBTALAR FUSION. A REVIEW OF THE DEVICE HISTORY FOR THE REPORTED LOT DID NOT INDICATE ANY ABNORMALITIES. NO CORRECTIVE ACTIONS ARE REQUIRED AT THIS TIME. A REVIEW OF THE LABELING DID NOT INDICATE ANY ABNORMALITIES. NO INDICATIONS OF MATERIAL, MANUFACTURING OR DESIGN RELATED PROBLEMS WERE FOUND DURING THE INVESTIGATION. IF THE DEVICE IS RETURNED OR IF ANY ADDITIONAL INFORMATION IS PROVIDED, THE INVESTIGATION WILL BE REASSESSED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE TALAR COMPONENTS ARE LOOSE. HAS CAUSED SIGNIFICANT METALLOSIS IN SURROUNDING TISSUES. AT LEAST ONE OF THE SCREWS THROUGH THE PLATE BROKE TOO. WILL HAVE TO UNDERGO ANOTHER SURGERY.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE TALAR COMPONENTS ARE LOOSE. HAS CAUSED SIGNIFICANT METALLOSIS IN SURROUNDING TISSUES. AT LEAST ONE OF THE SCREWS THROUGH THE PLATE BROKE TOO. WILL HAVE TO UNDERGO ANOTHER SURGERY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    262251 INVISION¿ TOTAL ANKLE SYSTEM PROSTHESIS, ANKLE, SEMI-CONSTRAINED, CEMENTED, METAL/POLYMER HSN WRIGHT MEDICAL TECHNOLOGY INC 1597240

    Patients

    Seq Age Sex Outcome Treatment
    1 77 YR Female Required Intervention| H