BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INFINITY EVERLAST SZ 4 10MM TOTAL ANKLE SYSTEM

    MDR report key: 17313125 · Received July 12, 2023

    Report

    Report Number
    3010667733-2023-00382
    Event Type
    Injury
    Date Received
    July 12, 2023
    Date of Event
    February 14, 2023
    Report Date
    September 5, 2023
    Manufacturer
    WRIGHT MEDICAL TECHNOLOGY INC
    Product Code
    HSN
    UDI-DI
    00889797074612
    PMA / PMN Number
    K193067
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE COMPLAINT COULDN'T BE CONFIRMED, SINCE THE DEVICE WAS NOT RETURNED FOR EVALUATION AND NO OTHER EVIDENCES WERE PROVIDED. 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. MORE DETAILED INFORMATION ABOUT THE COMPLAINT EVENT MUST BE AVAILABLE IN ORDER TO DETERMINE THE ROOT CAUSE OF THE COMPLAINT EVENT. IF THE DEVICE IS RETURNED OR IF ANY ADDITIONAL INFORMATION IS PROVIDED, THE INVESTIGATION WILL BE REASSESSED.

    Additional Manufacturer Narrative · 0

    ONCE THE INVESTIGATION HAS BEEN COMPLETED ANY ADDITIONAL INFORMATION WILL BE REPORTED IN A SUPPLEMENTAL REPORT. H3 OTHER TEXT : DEVICE REMAINS IMPLANTED IN PATIENT.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE PATIENT PRESENTED FOR A 6 MONTH POST OP VISIT AND REPORTED CONTINUED RIGHT ANKLE PAIN, MOSTLY ABOUT THE ANTERIOR ANKLE JOINT. PATIENT IS UNABLE TO DORSIFLEX PAST NEUTRAL AND HAS TROUBLE MAINTAINING A NORMAL GAIT PATTERN. ACTIONS TAKEN TO RESOLVE THIS WERE MEDICATION (UNKNOWN), ROCKER-BOTTOM SHOES AND USE OF A COMPRESSION SOCK AT WORK.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE PATIENT PRESENTED FOR A 6 MONTH POST OP VISIT AND REPORTED CONTINUED RIGHT ANKLE PAIN, MOSTLY ABOUT THE ANTERIOR ANKLE JOINT. PATIENT IS UNABLE TO DORSIFLEX PAST NEUTRAL AND HAS TROUBLE MAINTAINING A NORMAL GAIT PATTERN. ACTIONS TAKEN TO RESOLVE THIS WERE MEDICATION (UNKNOWN), ROCKER-BOTTOM SHOES AND USE OF A COMPRESSION SOCK AT WORK.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    333539 INFINITY EVERLAST SZ 4 10MM TOTAL ANKLE SYSTEM PROSTHESIS, ANKLE, SEMI-CONSTRAINED, CEMENTED, METAL/POLYMER HSN WRIGHT MEDICAL TECHNOLOGY INC 33684410 1688788 00889797074612

    Patients

    Seq Age Sex Outcome Treatment
    1 47 YR Male Required Intervention