BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INFINITY¿ TOTAL ANKLE SYSTEM

    MDR report key: 14848479 · Received June 28, 2022

    Report

    Report Number
    3010667733-2022-00229
    Event Type
    Injury
    Date Received
    June 28, 2022
    Date of Event
    June 1, 2022
    Report Date
    September 12, 2022
    Manufacturer
    WRIGHT MEDICAL TECHNOLOGY INC
    Product Code
    HSN
    UDI-DI
    00840420122049
    PMA / PMN Number
    K123954
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NL
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    ANALYSIS RESULTS ARE NOT AVAILABLE AT THE TIME OF THIS REPORT. A FOLLOW-UP REPORT WILL BE SENT WHEN THE ANALYSIS IS COMPLETE.

    Additional Manufacturer Narrative · 0

    CORRECTION: H6 DEVICE CODE, H6 METHOD CODE AND H6 CLINICAL CODE THE COMPLAINT COULDN'T BE CONFIRMED, SINCE THE RETURNED IMAGE FOR EVALUATION DON'T MATCHES THE ALLEGED FAILURE. MEDICAL PROFESSION REVIEWED THE RECEIVED INFORMATION AND NOTED: THE CLINICAL INFORMATION OF PAIN ON WEIGHTBEARING AND THE 99MTC-HDP BONE SCAN REVEALING HIGH ACTIVITY CAUDAL TO THE TALAR COMPONENT ARE INDEED MOST LIKELY DUE TO ASEPTIC LOOSENING OF THE TALAR COMPONENT. THE IMPLANT AS SUCH LOOKS IN ORDER, AND IT IS WELL IMPLANTED. NO OTHER ABNORMALITIES CAN BE FOUND. 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 AS WELL AS THE AFFECTED DEVICE 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. H3 OTHER TEXT : DEVICE DISPOSITION UNKNOWN.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE PATIENT UNDERWENT A TOTAL ANKLE REPLACEMENT SURGERY. ALLEGEDLY, THE PATIENT MAY NEED TO UNDERGO A REVISION SURGERY FOR REASONS THAT WERE NOT AVAILABLE AT THE TIME OF THIS REPORT.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE PATIENT UNDERWENT A TOTAL ANKLE REPLACEMENT SURGERY. ALLEGEDLY, THE PATIENT MAY NEED TO UNDERGO A REVISION SURGERY DUE TO THE PATIENT HAVING A LOT OF PAIN WHICH PERSISTED DESPITE APPEARANCE OF UNION OF PREVIOUSLY SUSTAINED MEDIAL MALLEOLEAR FRACTURE. ADDITIONAL 531 MBQ 99MTC-HDP BONE SCAN REVEALED HIGH ACTIVITY CAUDAL TO THE TALAR COMPONENT MOST LIKELY DUE TO ASEPTIC LOOSENING

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2017299 INFINITY¿ TOTAL ANKLE SYSTEM PROSTHESIS, ANKLE, SEMI-CONSTRAINED, CEMENTED, METAL/POLYMER HSN WRIGHT MEDICAL TECHNOLOGY INC 33630023 1697704 00840420122049

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Required Intervention| H