BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INFINITY TALAR DOME SZ 1 TOTAL ANKLE SYSTEM

    MDR report key: 21966439 · Received May 6, 2025

    Report

    Report Number
    3010667733-2025-00532
    Event Type
    Injury
    Date Received
    May 6, 2025
    Date of Event
    April 29, 2024
    Report Date
    July 7, 2025
    Manufacturer
    WRIGHT MEDICAL TECHNOLOGY INC
    Product Code
    HSN
    UDI-DI
    00840420122025
    PMA / PMN Number
    K123954
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    BASED ON THE AVAILABLE INFORMATION THE DEVICE WILL NOT BE RETURNED THEREFORE AN EVALUATION OF THE DEVICE CANNOT BE PERFORMED. SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE, IT WILL BE PROVIDED IN A SUPPLEMENTAL REPORT.

    Additional Manufacturer Narrative · 0

    THE REPORTED EVENT COULD NOT BE CONFIRMED SINCE THE AFFECTED DEVICE WAS NOT RETURNED FOR EVALUATION AND NO OTHER EVIDENCE WAS PROVIDED. A REVIEW OF THE DEVICE HISTORY FOR THE REPORTED LOT DID NOT INDICATE ANY ABNORMALITIES. NO CORRECTIVE ACTIONS ARE REQUIRED CURRENTLY. NO INDICATIONS OF MATERIAL, MANUFACTURING OR DESIGN-RELATED PROBLEMS WERE FOUND DURING THE INVESTIGATION. MORE DETAILED INFORMATION ABOUT THE COMPLAINT EVENT AS WELL AS THE AFFECTED DEVICE MUST BE AVAILABLE TO DETERMINE THE ROOT CAUSE OF THE COMPLAINT EVENT. IF THE DEVICE IS RETURNED OR ANY FURTHER INFORMATION IS PROVIDED, THE INVESTIGATION REPORT WILL BE REASSESSED.

    Description of Event or Problem · 0

    AS REPORTED: SUBJECT: 925-005 UK INFINITY TOTAL ANKLE SYSTEM STUDY BILATERAL LEG OEDEMA, ONLY MILD ON THE RIGHT SIDE. SUSPECTS CARDIAC CAUSE; THEREFORE REQUESTED CT OF LEFT ANKLE AND IF ALL OK TO REFER TO GP FOR REVIEW."

    Description of Event or Problem · 0

    AS REPORTED: SUBJECT: (B)(6) UK INFINITY TOTAL ANKLE SYSTEM STUDY. BILATERAL LEG OEDEMA, ONLY MILD ON THE RIGHT SIDE. SUSPECTS CARDIAC CAUSE; THEREFORE, REQUESTED CT OF LEFT ANKLE AND IF ALL OK TO REFER TO GP FOR REVIEW."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    66477 INFINITY TALAR DOME SZ 1 TOTAL ANKLE SYSTEM PROSTHESIS, ANKLE, SEMI-CONSTRAINED, CEMENTED, METAL/POLYMER HSN WRIGHT MEDICAL TECHNOLOGY INC 1612760 00840420122025

    Patients

    Seq Age Sex Outcome Treatment
    1 81 YR Female Other