INFINITY 33653308Recalls & reported problems

Summary

The FDA's MAUDE database contains 10 adverse event reports that list this exact device (DI 00840420122711), received between Mar 20, 2024 and Dec 15, 2025 — classified as 10 injuries.

The most frequently reported specific device problem is “Osseointegration Problem” (2 reports).

Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. What reports can and can't tell you · How this data works · Data updated Oct 16, 2026.

Most reported problems

Recent adverse event reports

The 10 most recent of 10 reports, in the reporter's own words as published by the FDA.

• InjuryDec 15, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE MANUFACTURER RECEIVED A REPORT FROM THE NATIONAL JOINT REGISTRY THAT CONTAINS UNPUBLISHED COLLECTED DATA ON THE USAGE AND THE OUTCOMES OF THE ANKLE JOINT REPLACEMENT. THE REPORT DETAILS ANALYSIS PROVIDED FOR REVISION PROCEDURES PERFORMED FOR THE MONTHLY REPORT OF (B)(6) 2025. DURING THE REVIEW OF THE REPORT, IT WAS IDENTIFIED THAT A PATIENT REQUIRED REVISION SURGERY DUE TO ACTIVE INFECTION WHICH WAS NOT PREVIOUSLY REPORTED TO THE MANUFACTURER.

  Patient problems: Unspecified Infection

  MAUDE report 23803985 ↗
• InjuryMar 6, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE MANUFACTURER RECEIVED A REPORT FROM THE NATIONAL JOINT REGISTRY THAT CONTAINS UNPUBLISHED COLLECTED DATA ON THE USAGE AND THE OUTCOMES OF THE ANKLE JOINT REPLACEMENT. THE REPORT DETAILS ANALYSIS PROVIDED FOR REVISION PROCEDURES PERFORMED UNTIL (B)(6) 2024. DURING THE REVIEW OF THE REPORT, IT WAS IDENTIFIED THAT ON (B)(6) 2024 A PATIENT REQUIRED REVISION SURGERY DUE TO UNEXPECTED PAIN, WHICH WAS NOT PREVIOUSLY REPORTED TO THE MANUFACTURER.

  Patient problems: Implant Pain

  MAUDE report 21535818 ↗
• InjuryFeb 13, 2025Osseointegration Problem; Osseointegration Problem

  THE MANUFACTURER RECEIVED A REPORT FROM THE NATIONAL JOINT REGISTRY THAT CONTAINS UNPUBLISHED COLLECTED DATA ON THE USAGE AND THE OUTCOMES OF THE ANKLE JOINT REPLACEMENT. THE REPORT DETAILS ANALYSIS PROVIDED FOR REVISION PROCEDURES PERFORMED UNTIL (B)(6) 2024. DURING THE REVIEW OF THE REPORT, IT WAS IDENTIFIED THAT ON (B)(6) 2023 A PATIENT REQUIRED REVISION SURGERY DUE TO ASEPTIC LOOSENING, WHICH WAS NOT PREVIOUSLY REPORTED TO THE MANUFACTURER. REVISION PROCEDURE TYPE: STAGE 1 OF 2 STAGE REVISION.

  Patient problems: Inadequate Osseointegration

  MAUDE report 21381899 ↗
• InjuryDec 19, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  AS REPORTED: "(B)(6). ADVERSE EVENT TERM: LEFT FOOT PAIN IN 1ST TMTJ AND CALCANEOBOID JOINT NO PROBLEMS WITH ANKLE REPLACEMENT JOINT BUT REQUIRES FUSION TO STABILISE 1ST TMT JOINT AND CALCANEOBOID JOINT TO REDUCE PAIN IN LEFT FOOT."

  Patient problems: Implant Pain

  MAUDE report 20976215 ↗
• InjuryOct 11, 2024Osseointegration Problem; Osseointegration Problem

  THE MANUFACTURER RECEIVED A REPORT FROM THE NATIONAL JOINT REGISTRY THAT CONTAINS UNPUBLISHED COLLECTED DATA ON THE USAGE AND THE OUTCOMES OF THE ANKLE JOINT REPLACEMENT. THE REPORT DETAILS ANALYSIS PROVIDED FOR REVISION PROCEDURES PERFORMED BETWEEN JANUARY 2018 ¿ DECEMBER 2023. DURING THE REVIEW OF THE REPORT, IT WAS IDENTIFIED THAT ON (B)(6) 2020 A PATIENT REQUIRED REVISION SURGERY DUE TO ASEPTIC LOOSENING - TIBIAL COMPONENT, WHICH WAS NOT PREVIOUSLY REPORTED TO THE MANUFACTURER.

  Patient problems: Inadequate Osseointegration

  MAUDE report 20426325 ↗
• InjurySep 11, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  AS REPORTED: "PROGRESSIVE TIBIAL CYST ON X-RAY. (B)(6) 2023: ATTENDED FOR ROUTINE REVIEW, RELATIVELY ASYMPTOMATIC WITH GOOD FUNCTION AT THE ANKLE. ROUTINE X-RAY REVEALED TIBIAL CYST. REVIEWED BY SURGEON AND A CT SCAN HAS BEEN REQUESTED TO GAIN MORE INFORMATION. (B)(6) 2023: NO CHANGE. MONITOR SET UP. REPEAT CT AND REVIEW IN (B)(6)."

  Patient problems: Cyst(s)

  MAUDE report 20188466 ↗
• InjurySep 11, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  AS REPORTED: "BIG CYSTIC CHANGES FOUND IN THE RIGHT MEDIAL MALLEOLUS. (B)(6) 2022: BIG CYSTIC CHANGES NOTED IN THE MEDIAL MALLEOLUS DURING A ROUTINE X-RAY IN CLINIC. PATIENT NOT COMPLAINING OF ANY SEVERE PAIN/DISCOMFORT OR PROBLEMS WITH THEIR RIGHT ANKLE. FURTHER INVESTIGATION SHOW LESION TO BE A GEODE TYPE LESION NEXT TO THE RIGHT TOTAL ANKLE REPLACEMENT. (B)(6) 2022: DEBRIDEMENT OF LARGE INTRAOSSEOUS GANGLION/GEODE. (B)(6) 2023: WOUND FULLY HEALED".

  Patient problems: Cyst(s); Wound Dehiscence

  MAUDE report 20188394 ↗
• InjurySep 11, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  AS REPORTED: "PAIN IN LEFT ANKLE JOINT. PATIENT STARTED NOTICING PAIN IN THEIR LEFT ANKLE JOINT PREDOMINANTLY ANTERO-LATERAL, ANTERO-MEDIAL AND ANTERIOR. X-RAYS SHOW NO CHANGE WITH LEFT ANKLE, TAKEN (B)(6) 2023. TO BE LISTED FOR DIAGNOSTIC/THERAPEUTIC INJECTION AS A DAY CASE."

  Patient problems: Implant Pain

  MAUDE report 20188345 ↗
• InjuryJun 28, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  AS REPORTED: MEDIAL MALLEOLUS FRACTURE. UNDISPLACED DURING INDEX PROCEDURE. OSTEOPOROTIC BASE PREVIOUS FIBULAR STRESS FRACTURE. FRACTURE AS DORSIFLEXED ANKLE WITH IMPLANT IN. WAS TREATMENT REQUIRED FOR THIS ADVERSE EVENT? YES. ACTION TAKEN: INTRAOPERATIVE REPAIR PERFORMED DURING INDEX SURGERY."

  Patient problems: Bone Fracture(s)

  MAUDE report 19634706 ↗
• InjuryMar 20, 2024Loss of Osseointegration; Adverse Event Without Identified Device or Use Problem; Loss of Osseointegration; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT HAS NOTICED PAIN AND SWELLING OF THE ANKLE, 6 YEARS POST-OP OF A TOTAL ANKLE REPLACEMENT. CT SCANS SHOW CYSTIC CHANGES IN THE TIBIA AND TALUS WITH LOSS OF BONE DENSITY. IT IS POSSIBLE THAT THE PATIENT MAY UNDERGO A REVISION WITH REMOVAL OF IMPLANTS AND CHANGING TO A ANKLE FUSION WITH CADAVER BONE. CURRENTLY, THE PATIENT CAN WALK ON THE ANKLE BUT WEARS A BOOT TO LIMIT THE "SHEARING" ACTION TO THE ANKLE.

  Patient problems: Cyst(s); Implant Pain; Osteopenia/ Osteoporosis; Swelling/ Edema

  MAUDE report 18942709 ↗