INFINITY 33650005Recalls & reported problems

Summary

The FDA's MAUDE database contains 32 adverse event reports that list this exact device (DI 00840420122520), received between May 26, 2021 and Jul 16, 2026 — classified as 32 injuries.

The most frequently reported specific device problem is “Migration” (6 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 32 reports, in the reporter's own words as published by the FDA.

• InjuryJul 16, 2026Unstable

  SUBJECT: (B)(6). UK INFINITY® TOTAL ANKLE SYSTEM STUDY. (B)(6) 2018. INSTABILITY IN RIGHT ANKLE WITH ONGOING PAIN. VERY POOR BONE QUALITY. LACK OF BONE INTEGRATION INTO PRODENSE GRAFTING IN THE RIGHT ANKLE. STRONG HISTORY OF INFECTION IN KNEE. PATIENT WAS DUE TO BE ADMITTED TO RULE OUT POOR BONE INTEGRATION VERSUS INFECTION IN THE ANKLE, HOWEVER PATIENT DID NOT WISH TO PROCEED.

  Patient problems: Joint Laxity; Pain; Unspecified Infection

  MAUDE report 25841018 ↗
• 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  THE MANUFACTURER RECEIVED A REPORT FROM THE NATIONAL JOINT REGISTRY THAT CONTAINS UNPUBLISHED COLLECTED DATA ON THE USAGE AND THE OUTCOMES OF THE ANKLE JOINT REPLACEMENT.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 ON 2025. DURING THE REVIEW OF THE REPORT, IT WAS IDENTIFIED THAT ON (B)(6) 2025 A PATIENT REQUIRED REVISION SURGERY DUE TO INFECTION ACTIVE, WHICH WAS NOT PREVIOUSLY REPORTED TO THE MANUFACTURER.

  Patient problems: Unspecified Infection

  MAUDE report 23957563 ↗
• InjuryDec 1, 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  THE MANUFACTURER RECEIVED A REPORT FROM THE NATIONAL JOINT REGISTRY THAT CONTAINS UNPUBLISHED COLLECTED DATA ON THE USAGE AND THE OUTCOMES OF THE ANKLE JOINT REPLACEMENT.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 UNEXPLAINED PAIN, WHICH WAS NOT PREVIOUSLY REPORTED TO THE MANUFACTURER.

  Patient problems: Pain

  MAUDE report 23686999 ↗
• InjuryOct 22, 2025Osseointegration Problem; Osseointegration Problem

  THE DIGITAL STRYKER PROPHECY TEAM RECEIVED A CT SCAN INDICATING THAT THE PATIENT MAY REQUIRE A REVISION SURGERY DUE TO ASEPTIC LOOSENING.

  Patient problems: Inadequate Osseointegration

  MAUDE report 23361333 ↗
• InjurySep 4, 2025Loss of Osseointegration; Loss of Osseointegration

  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) 2025. DURING THE REVIEW OF THE REPORT, IT WAS IDENTIFIED THAT ON (B)(6) 2025 A PATIENT REQUIRED REVISION SURGERY DUE TO ASEPTIC LOOSENING AND LYSIS OF TIBIAL AND TALAR COMPONENTS, WHICH WAS NOT PREVIOUSLY REPORTED TO THE MANUFACTURER.

  Patient problems: Osteolysis

  MAUDE report 22963641 ↗
• InjuryMay 27, 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) 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 22091840 ↗
• InjuryMay 26, 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. WOUND HEALING PROBLEMS PATIENT WAS GETTING SOME BLISTERING AROUND THE PROXIMAL EDGE OF THE WOUND WITH DISCHARGE, NO OVERT INFECTION. FLUCLOXACILLIN WAS PRESCRIBED. ATTENDED A CLINIC ON (B)(6) 2019, THE WOUND SEEMED CLEAN AND DRY, NO SIGNS OF INFECTION, WAS TAKEN OFF ANTI-BIOTICS."

  Patient problems: Wound Dehiscence

  MAUDE report 22084169 ↗
• InjuryMay 21, 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) 2023 A PATIENT REQUIRED REVISION SURGERY DUE TO INFECTION, WHICH WAS NOT PREVIOUSLY REPORTED TO THE MANUFACTURER.

  Patient problems: Unspecified Infection

  MAUDE report 22059333 ↗
• 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 INFECTION-ACTIVE WHICH WAS NOT PREVIOUSLY REPORTED TO THE MANUFACTURER.

  Patient problems: Unspecified Infection

  MAUDE report 22030167 ↗
• InjuryApr 16, 2025Osseointegration Problem; Migration; Osseointegration Problem; Migration

  THE DIGITAL STRYKER PROPHECY TEAM RECEIVED A CT SCAN INDICATING THAT THE PATIENT MAY REQUIRE A REVISION SURGERY DUE TO PAIN AND TIBIAL TRAY SUBSIDENCE.

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

  MAUDE report 21849778 ↗
• InjuryMar 19, 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) 2023 A PATIENT REQUIRED REVISION SURGERY DUE TO MALALIGNMENT, WEAR OF POLYETHYLENE COMPONENT AND SOFT TISSUE IMPINGEMENT WHICH WAS NOT PREVIOUSLY REPORTED TO THE MANUFACTURER.

  Patient problems: Joint Impingement; Subluxation

  MAUDE report 21644080 ↗
• 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 APRIL 2024. DURING THE REVIEW OF THE REPORT, IT WAS IDENTIFIED THAT ON (B)(6) 2024 A PATIENT REQUIRED REVISION SURGERY DUE TO INFECTION, WHICH WAS NOT PREVIOUSLY REPORTED TO THE MANUFACTURER.

  Patient problems: Unspecified Infection

  MAUDE report 21535813 ↗
• InjuryDec 23, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  AS REPORTED: "STUDY UK INFINITY TOTAL ANKLE SYSTEM SUBJECT: 100-009 VARUS RELEASE - SUPERFICIAL AND DEEP DELTOID. LATERAL GUTTER OSTEOPHYTE EXCISED. AT THIS POINT AN UNDISPLACED SHEAR FRACTURE MEDIAL MALL WAS NOTED DURING THE ARTHROPLASTY OF THE RIGHT ANKLE THE FOUND FRACTURE WAS FIXED AND STABILIZED."

  Patient problems: Bone Fracture(s)

  MAUDE report 21000887 ↗
• 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) 2018 A PATIENT REQUIRED REVISION SURGERY DUE TO INFECTION & LYSIS, WHICH WAS NOT PREVIOUSLY REPORTED TO THE MANUFACTURER.

  Patient problems: Osteolysis; Unspecified Infection

  MAUDE report 20901543 ↗
• 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) 2019 A PATIENT REQUIRED REVISION SURGERY DUE TO INFECTION & LYSIS, WHICH WAS NOT PREVIOUSLY REPORTED TO THE MANUFACTURER.

  Patient problems: Osteolysis; Unspecified Infection

  MAUDE report 20901530 ↗
• 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 (B)(6) 2018 ¿ (B)(6) 2023. DURING THE REVIEW OF THE REPORT, IT WAS IDENTIFIED THAT ON (B)(6) 2022 A PATIENT REQUIRED REVISION SURGERY DUE TO INFECTION, ASEPTIC LOOSENING & LYSIS, WHICH WAS NOT PREVIOUSLY REPORTED TO THE MANUFACTURER.

  Patient problems: Inadequate Osseointegration; Osteolysis; Unspecified Infection

  MAUDE report 20853359 ↗
• InjuryDec 4, 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, WHICH WAS NOT PREVIOUSLY REPORTED TO THE MANUFACTURER.

  Patient problems: Unspecified Infection

  MAUDE report 20840933 ↗
• InjuryNov 7, 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 (B)(6) 2023. DURING THE REVIEW OF THE REPORT, IT WAS IDENTIFIED THAT ON (B)(6) 2022 A PATIENT REQUIRED REVISION SURGERY DUE TO HIGH SUSPICION (E.G. PUS OR CONFIRMED MICRO), WHICH WAS NOT PREVIOUSLY REPORTED TO THE MANUFACTURER.

  Patient problems: Unspecified Infection

  MAUDE report 20634396 ↗
• InjuryOct 9, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  AS REPORTED: "STUDY: UK INFINITY® TOTAL ANKLE SYSTEM SUBJECT: 700-001. STIFF ANKLE WITH SIGNIFICANT ARTHROFIBROSIS FRONT AND BACK. ANKLE. ARTHROSCOPY RESECTING SCAR TISSUE. NO COMPLICATIONS".

  Patient problems: Fibrosis; Loss of Range of Motion

  MAUDE report 20407842 ↗
• InjurySep 29, 2023Insufficient Device Problem Information; Appropriate Device Problem Term/Code Not Available; Insufficient Device Problem Information; Appropriate Device Problem Term/Code Not Available

  THE DIGITAL STRYKER PROPHECY TEAM RECEIVED A CT SCAN INDICATING THAT THE PATIENT MAY REQUIRE A REVISION SURGERY DUE TO PAIN AND POSSIBLE LOOSENING/CYSTIC CHANGES.

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Implant Pain

  MAUDE report 17848113 ↗
• InjuryJul 28, 2023Migration; Migration

  IT WAS REPORTED THAT PATIENT HAD AN TOTAL ANKLE REPLACEMENT ABOUT 1 YEAR AGO AND SEEMS TO BE EXPERIENCING NON-INTEGRATION OF HIS TIBIAL COMPARTMENT. HE HAS NOTICED SINKING IN THE POSTERIOR PART OF THE TIBIA, AS WELL AS IN THE ANTERIOR PART.

  Patient problems: Inadequate Osseointegration; Osteolysis

  MAUDE report 17415510 ↗
• InjuryJul 28, 2023Osseointegration Problem; Migration; Osseointegration Problem; Migration

  IT WAS REPORTED THAT PATIENT HAD AN TOTAL ANKLE REPLACEMENT ABOUT 1 YEAR AGO AND SEEMS TO BE EXPERIENCING NON-INTEGRATION OF HIS TIBIAL COMPARTMENT. HE HAS NOTICED SINKING IN THE POSTERIOR PART OF THE TIBIA, AS WELL AS IN THE ANTERIOR PART.

  Patient problems: Inadequate Osseointegration; Osteolysis

  MAUDE report 17415508 ↗
• InjuryJun 26, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT UNDERWENT A TOTAL ANKLE REPLACEMENT. ALLEGEDLY, THE PATIENT MAY NEED TO UNDERGO A REVISION SURGERY DUE TO PAIN AND PERHAPS VARUS MALALIGNMENT.

  Patient problems: Implant Pain

  MAUDE report 17200458 ↗
• InjuryMar 6, 2023Migration; Migration

  IT WAS REPORTED THAT THE PATIENT UNDERWENT A TOTAL ANKLE REPLACEMENT. UPON A CT SCAN IT WAS NOTED THAT THERE WAS CYSTIC FORMATION AROUND BOTH TIBIAL AND TALUS COMPONENTS. EXPECTED LOOSENING OF BOTH COMPONENTS. NO FOLLOW UP PROCEDURES.

  Patient problems: Bone Fracture(s); Cyst(s); Inadequate Osseointegration

  MAUDE report 16492006 ↗
• InjuryAug 4, 2022Migration; Migration

  IT WAS REPORTED THAT THE PATIENT WILL NEED TO UNDERGO A REVISION SURGERY DUE TO TIBIAL COMPONENT LOOSENING.

  Patient problems: Cyst(s); Inadequate Osseointegration

  MAUDE report 15169155 ↗