INFINITY 33650002Recalls & reported problems

Summary

The FDA's MAUDE database contains 30 adverse event reports that list this exact device (DI 00840420122490), received between Nov 23, 2021 and Jul 8, 2026 — classified as 30 injuries.

The most frequently reported specific device problem is “Osseointegration Problem” (7 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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 25 most recent of 30 reports, in the reporter's own words as published by the FDA.

• InjuryJul 8, 2026Adverse Event Without Identified Device or Use Problem

  SUBJECT: (B)(6) UK INFINITY TOTAL ANKLE SYSTEM STUDY. DISCOMFORT/TENDERNESS MEDICAL ASPECT OF ANKLE (RIGHT). PATIENT EXPERIENCING DISCOMFORT/TENDERNESS, INFORMED BY HER PHYSIOTHERAPIST THAT IT COULD BE TENDON RELATED. USING CRUTCHES TO MOBILIZE AND FINDING IT UNCOMFORTABLE TO GET UP FROM SITTING. PATIENT DISCUSSING WITH HER CONSULTANT. PROCEDURE RELATED: YES.

  Patient problems: Discomfort; Pain

  MAUDE report 25746047 ↗
• InjuryJun 8, 2026Adverse 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  THE MANUFACTURER RECEIVED A REPORT FROM THE NATIONAL JOINT REGISTRY THAT CONTAINS UNPUBLISHED COLLECTED DATA ON THE USAGE AND THE OUTCOMES OF THE ANKLE JOINT REPLACEMENT.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) 2026 DURING THE REVIEW OF THE REPORT, IT WAS IDENTIFIED THAT A PATIENT REQUIRED REVISION SURGERY DUE TO MALALIGNMENT WHICH WAS NOT PREVIOUSLY REPORTED TO THE MANUFACTURER.

  Patient problems: Subluxation

  MAUDE report 25426583 ↗
• InjuryMar 9, 2026Adverse 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  THE MANUFACTURER RECEIVED A REPORT FROM THE NATIONAL JOINT REGISTRY THAT CONTAINS UNPUBLISHED COLLECTED DATA ON THE USAGE AND THE OUTCOMES OF THE ANKLE JOINT REPLACEMENT.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 JANUARY 2026. DURING THE REVIEW OF THE REPORT, IT WAS IDENTIFIED THAT A PATIENT REQUIRED REVISION SURGERY DUE TO UNEXPLAINED PAIN WHICH WAS NOT PREVIOUSLY REPORTED TO THE MANUFACTURER.

  Patient problems: Pain

  MAUDE report 24543934 ↗
• InjuryJan 5, 2026Adverse 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 BETWEEN 2022-2025. DURING THE REVIEW OF THE REPORT, IT WAS IDENTIFIED THAT ON (B)(6) 2025 A PATIENT REQUIRED REVISION SURGERY DUE TO UNEXPLAINED PAIN, WHICH WAS NOT PREVIOUSLY REPORTED TO THE MANUFACTURER.

  Patient problems: Pain

  MAUDE report 23957571 ↗
• InjuryOct 20, 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 BETWEEN 2016 TO 2025. DURING THE REVIEW OF THE REPORT, IT WAS IDENTIFIED THAT ON (B)(6) 2025 A PATIENT REQUIRED REVISION SURGERY DUE TO LYSIS IN TIBIA AND LYSIS IN TALUS, WHICH WAS NOT PREVIOUSLY REPORTED TO THE MANUFACTURER.

  Patient problems: Osteolysis

  MAUDE report 23335170 ↗
• InjuryOct 20, 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 BETWEEN 2016 TO 2025. DURING THE REVIEW OF THE REPORT, IT WAS IDENTIFIED THAT ON (B)(6) 2025, A PATIENT REQUIRED REVISION SURGERY DUE TO MALALIGNMENT, WHICH WAS NOT PREVIOUSLY REPORTED TO THE MANUFACTURER.

  Patient problems: Subluxation

  MAUDE report 23335081 ↗
• InjuryAug 14, 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 BETWEEN 2016 TO 2025. DURING THE REVIEW OF THE REPORT, IT WAS IDENTIFIED THAT ON (B)(6) 2025 A PATIENT REQUIRED REVISION SURGERY DUE TO MALALIGNMENT/STIFFNESS, WHICH WAS NOT PREVIOUSLY REPORTED TO THE MANUFACTURER.

  Patient problems: Loss of Range of Motion; Subluxation

  MAUDE report 22804439 ↗
• InjuryMay 26, 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) 2025. DURING THE REVIEW OF THE REPORT, IT WAS IDENTIFIED THAT ON (B)(6) 2024, A PATIENT REQUIRED REVISION SURGERY DUE TO ASEPTIC LOOSENING OF TIBIAL COMPONENT AND LYSIS OF TIBIA, WHICH WAS NOT PREVIOUSLY REPORTED TO THE MANUFACTURER.

  Patient problems: Inadequate Osseointegration; Osteolysis

  MAUDE report 22083356 ↗
• InjuryMay 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 BETWEEN (B)(6) 2024. DURING THE REVIEW OF THE REPORT, IT WAS IDENTIFIED THAT ON (B)(6) 2024, A PATIENT REQUIRED REVISION SURGERY DUE TO UNEXPLAINED PAIN AND STIFFNESS WHICH WAS NOT PREVIOUSLY REPORTED TO THE MANUFACTURER.

  Patient problems: Loss of Range of Motion; Pain

  MAUDE report 22030160 ↗
• InjuryMay 13, 2025Material Fragmentation; Osseointegration Problem; Migration; Material Fragmentation; Osseointegration Problem; Migration

  THE DIGITAL STRYKER PROPHECY TEAM RECEIVED A CT SCAN INDICATING THAT THE PATIENT MAY REQUIRE A REVISION SURGERY OF TALAR COMPONENTS FOR REASONS OF SUBSIDENCE AND DELAMINATION.

  Patient problems: Inadequate Osseointegration

  MAUDE report 22008607 ↗
• InjuryMay 6, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  AS REPORTED: "STUDY: UK INFINITY® TOTAL ANKLE SYSTEM SUBJECT: 500-071. DISCOMFORT TO ANTEROMEDIAL ASPECT OF RIGHT ANKLE JOINT THAT RADIATES UP THE LEG. X-RAYS SHOW BONE FORMATION AT THE FRONT OF THE JOINT. LISTED FOR EXPLORATION OF THE ANTEROMEDIAL ASPECT OF THE RIGHT ANKLE JOINT AND REMOVAL OF BONY FORMATION."

  Patient problems: Discomfort; Extraskeletal ossification; Pain

  MAUDE report 21966504 ↗
• InjuryMay 6, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  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."

  Patient problems: Swelling/ Edema

  MAUDE report 21966436 ↗
• InjuryFeb 4, 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 BETWEEN (B)(6) 2018 ¿(B)(6) 2023. DURING THE REVIEW OF THE REPORT, IT WAS IDENTIFIED THAT ON (B)(6) 2019 A PATIENT REQUIRED REVISION SURGERY DUE TO UNEXPLAINED PAIN, WHICH WAS NOT PREVIOUSLY REPORTED TO THE MANUFACTURER.

  Patient problems: Implant Pain

  MAUDE report 21303202 ↗
• InjuryDec 11, 2024Adverse 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 BETWEEN JANUARY 2018 ¿ DECEMBER 2023. DURING THE REVIEW OF THE REPORT, IT WAS IDENTIFIED THAT ON (B)(6) 2021 A PATIENT REQUIRED REVISION SURGERY DUE TO INFECTION, LYSIS & PAIN, WHICH WAS NOT PREVIOUSLY REPORTED TO THE MANUFACTURER.

  Patient problems: Implant Pain; Osteolysis; Unspecified Infection

  MAUDE report 20901774 ↗
• InjuryDec 5, 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 INFECTION & ASEPTIC LOOSENING, WHICH WAS NOT PREVIOUSLY REPORTED TO THE MANUFACTURER.

  Patient problems: Inadequate Osseointegration; Unspecified Infection

  MAUDE report 20850857 ↗
• InjuryDec 4, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT AN INFINITY ANKLE REVISION TOOK PLACE. REVISED TO AN INVISION TOTAL ANKLE.

  Patient problems: Insufficient Information

  MAUDE report 20842766 ↗
• InjuryOct 28, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  AS REPORTED: "SUBJECT: 900-025 UK INFINITY® TOTAL ANKLE SYSTEM STUDY. PAINFUL TAR- SPECT CT- ARTHROSCOPIC DEBRIDEMENT OF ANTEROMEDIAL BONE SPUR. PRESENTED WITH PAINFUL TAR (B)(6) 2019. INVESTIGATIONS WERE ARRANGED. SEEN (B)(6) 2019 WIT SPEC CT RESULTS, CONSENTED FOR EUA AND ARTHROSCOPIC EXPLORATION OF TAR. 03 JAN 2-20 ARTHROSCOPIC DEBRIDEMENT, IMPLANT STABLE. NO LOOSENING OF IMPLANT OR INFECTION.".

  Patient problems: Implant Pain

  MAUDE report 20543368 ↗
• InjurySep 20, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT EXPERIENCED CONTINUOUS PAIN AFTER SURGERY. THE STRYKER PROPHECY TEAM HAS RECEIVED A CT SCAN FOR UPCOMING REVISION SURGERY WHICH SHOW THAT THE PRIOR TAR IMPLANT IS A WRIGHT MEDICAL/STRYKER DEVICE.

  Patient problems: Implant Pain

  MAUDE report 20272848 ↗
• InjuryAug 27, 2024Osseointegration Problem; Osseointegration Problem

  THE DIGITAL STRYKER PROPHECY TEAM RECEIVED A CT SCAN INDICATING THAT THE PATIENT MAY REQUIRE A REVISION SURGERY. THE REASON OF REVISION WAS PAIN AND RADIOLUCENCY AROUND BOTH IMPLANTS.

  Patient problems: Implant Pain; Inadequate Osseointegration

  MAUDE report 20073897 ↗
• InjuryMay 28, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  AS REPORTED: "HOSPITALIZATION DUE TO PAIN IN RIGHT ANKLE. RIGHT ANKLE PAIN AND INABILITY TO WEIGHT BEAR. RIGHT ANKLE SWOLLEN AND HOT TO TOUCH. DIAGNOSED WITH GOUT ARTHRITIS AND COMMENCED ON COLCHICINE AND ANALGESIA. CONFUSED IN HOSPITAL INR FOUND TO BE ELEVATED AND IN RENAL FAILURE. RIVAROXIBAN SUSPENDED UNTIL RENAL FUNCTION IMPROVES."

  Patient problems: Ambulation or Postural Difficulties; Arthritis; Implant Pain; Renal Impairment; Swelling/ Edema

  MAUDE report 19404037 ↗
• InjuryMar 6, 2024Osseointegration Problem; Osseointegration Problem

  THE DIGITAL STRYKER PROPHECY TEAM RECEIVED A CT SCAN INDICATING THAT THE PATIENT MAY REQUIRE A REVISION SURGERY OF BOTH SIDES OF THE IMPLANT USING INVISION IMPLANTS. PATIENT HAD CONTINUED PAIN AND CT SCAN SUGGESTS SOME LOOSENING OF AT LEAST THE TIBIAL COMPONENT.

  Patient problems: Implant Pain; Inadequate Osseointegration

  MAUDE report 18852001 ↗
• InjuryJul 27, 2023Osseointegration Problem; Insufficient Device Problem Information; Osseointegration Problem; Insufficient Device Problem Information

  THE DIGITAL STRYKER PROPHECY TEAM RECEIVED A CT SCAN INDICATING THAT THE PATIENT MAY REQUIRE A REVISION SURGERY DUE TO LOOSENING OF THE TIBIAL TRAY AND ONGOING PAIN AFTER THE RIGHT TOTAL ANKLE REPLACEMENT.

  Patient problems: Cyst(s); Implant Pain; Inadequate Osseointegration; Insufficient Information

  MAUDE report 17410776 ↗
• InjuryJun 1, 2023Osseointegration Problem; Migration; Osseointegration Problem; Migration

  I WOULD REPORT THE EVENT LIKE THIS: IT WAS REPORTED THAT THE PATIENT WILL NEED TO UNDERGO A REVISION SURGERY DUE TO MOVEMENT OF THE TIBIAL TRAY. THE SURGEON PLANS ON REVISING THE TIBIAL TRAY AND SWITCHING THE POLY. IF THE TALAR IMPLANT NEEDS TO BE REPLACED IT WILL BE SWITCHED BUT AT THIS TIME THE SURGEON IS NOT CLEAR IF THAT WILL BE NECESSARY.

  Patient problems: Cyst(s); Inadequate Osseointegration; Insufficient Information

  MAUDE report 17036969 ↗
• InjuryDec 7, 2022Insufficient Device Problem Information; Migration; Insufficient Device Problem Information; Migration

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

  Patient problems: Cyst(s); Insufficient Information; Osteolysis

  MAUDE report 15933693 ↗
• InjuryAug 30, 2022Adverse Event Without Identified Device or Use Problem; Migration; Adverse Event Without Identified Device or Use Problem; Migration

  THE PATIENT UNDERWENT A TOTAL ANKLE REPLACEMENT SURGERY. ALLEGEDLY, THE PATIENT MAY NEED TO UNDERGO A REVISION SURGERY DUE TO REASONS THAT WERE NOT AVAILABLE AT THE TIME OF THIS REPORT. THE SURGEON IS PLANNING ON REVISING THE TIBIA IMPLANT AND KEEPING THE TALAR IMPLANT UNLESS IT HAS TO BE REMOVED TO REPLACE THE TIBIA.

  Patient problems: Failure of Implant; Insufficient Information

  MAUDE report 15325174 ↗