BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INFINITY EVERLAST SZ 3 6MM TOTAL ANKLE SYSTEM

    MDR report key: 21572187 · Received March 11, 2025

    Report

    Report Number
    3010667733-2025-00319
    Event Type
    Injury
    Date Received
    March 11, 2025
    Date of Event
    August 25, 2022
    Report Date
    May 21, 2025
    Manufacturer
    WRIGHT MEDICAL TECHNOLOGY INC
    Product Code
    HSN
    UDI-DI
    00889797101547
    PMA / PMN Number
    K193067
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    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 BE CONFIRMED BASED ON THE OPERATIVE NOTES AND THE ADMINISTRATION OF ANTIBIOTICS TO THE PATIENT. A MICROBIOLOGIST REVIEWED THE STERILIZATION PROCEDURES, ENVIRONMENTAL MONITORING, BIOBURDEN DATA AND THE DHR AND NOTED: THE SUBJECT DEVICE WAS PACKAGED ACCORDING TO ESTABLISHED DESIGN AND PROCESS SPECIFICATIONS AND WAS STERILIZED ACCORDING TO PROCEDURE. NO DEVIATIONS OR NON-CONFORMANCES COULD BE FOUND. 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 REASSESSED.

    Description of Event or Problem · 0

    AS REPORTED: "SUBJECT: (B)(6) INFINITY WITH ADAPTIS¿ TECHNOLOGY TOTAL ANKLE REPLACEMENT FOLLOW-UP (ITAR2). ON (B)(6) 2022: ON (B)(6) 2022, A PATIENT WAS PRESENTED WITH LATERAL ANKLE LACERATION FROM A BUSH HOGGING ACCIDENT ON (B)(6) 2022. THEY ORIGINALLY HAD 8 STITCHES BUT CUT THEM AT HOME A WEEK AFTER THAN BEING PLACED WHICH HAS LED TO WOUND DEHISCENCE. IT IS FAIRLY DEEP WITH SEROSANGUINEOUS DRAINAGE. KEFLEX X7 DAYS. DISCUSSED SIGNS AND SYMPTOMS OF INFECTION TO MONITOR FOR AND DRY DRESSING CHANGES EITHER DAILY OR TWICE A DAY DEPENDING ON DRAINAGE TO THE LATERAL LACERATION. UPDATE 24 AUG 2022: WORSENING. PLAN FOR RIGHT ANKLE IRRIGATION AND DEBRIDEMENT, BONE BIOPSY, PARTIAL EXCISION OF FIBULA, WITH POSSIBLE ADJACENT TISSUE TRANSFER. UPDATE 25 AUG 2022: SURGICAL INTERVENTION. MULTIPLE INJURIES TO STUDY ANKLE REQUIRING SURGICAL INTERVENTION. PARTIAL EXCISION OF FIBULA FOR OSTEOMYELITIS TRANSFER OF ADJACENT TISSUE."

    Description of Event or Problem · 0

    AS REPORTED: "SUBJECT: (B)(4) INFINITY WITH ADAPTIS¿ TECHNOLOGY TOTAL ANKLE REPLACEMENT FOLLOW-UP (ITAR2). (B)(6) 2022: ON (B)(6) 2022, A PATIENT WAS PRESENTED WITH LATERAL ANKLE LACERATION FROM A BUSH HOGGING ACCIDENT ON (B)(6) 2022. THEY ORIGINALLY HAD 8 STITCHES BUT CUT THEM AT HOME A WEEK AFTER THAN BEING PLACED WHICH HAS LED TO WOUND DEHISCENCE. IT IS FAIRLY DEEP WITH SEROSANGUINEOUS DRAINAGE. KEFLEX X7 DAYS. DISCUSSED SIGNS AND SYMPTOMS OF INFECTION TO MONITOR FOR AND DRY DRESSING CHANGES EITHER DAILY OR TWICE A DAY DEPENDING ON DRAINAGE TO THE LATERAL LACERATION. UPDATE 24 AUG 2022: WORSENING. PLAN FOR RIGHT ANKLE IRRIGATION AND DEBRIDEMENT, BONE BIOPSY, PARTIAL EXCISION OF FIBULA, WITH POSSIBLE ADJACENT TISSUE TRANSFER. UPDATE 25 AUG 2022: SURGICAL INTERVENTION. MULTIPLE INJURIES TO STUDY ANKLE REQUIRING SURGICAL INTERVENTION. PARTIAL EXCISION OF FIBULA FOR OSTEOMYELITIS TRANSFER OF ADJACENT TISSUE."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    337932 INFINITY EVERLAST SZ 3 6MM TOTAL ANKLE SYSTEM PROSTHESIS, ANKLE, SEMI-CONSTRAINED, CEMENTED, METAL/POLYMER HSN WRIGHT MEDICAL TECHNOLOGY INC 1677392 00889797101547

    Patients

    Seq Age Sex Outcome Treatment
    1 53 YR Male Required Intervention