INFINITY 33650014Recalls & reported problems

Summary

The FDA's MAUDE database contains 41 adverse event reports that list this exact device (DI 00840420122551), received between Jun 11, 2021 and Aug 17, 2026 — classified as 41 injuries.

The most frequently reported specific device problem is “Osseointegration Problem” (8 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 41 reports, in the reporter's own words as published by the FDA.

• InjuryAug 17, 2026Loss 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  The manufacturer received a report from the National Joint Registry that contains unpublished collected data on the usage and the outcomes of the ankle joint replacement.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 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 aseptic loosening of the tibial and talar components, with associated talar osteolysis (lysis of the talus) and fracture of the talar implant component which was not previously reported to the manufacturer.

  Patient problems: Osteolysis

  MAUDE report 50274697 ↗
• InjuryApr 28, 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  THE MANUFACTURER RECEIVED A REPORT FROM THE NATIONAL JOINT REGISTRY THAT CONTAINS UNPUBLISHED COLLECTED DATA ON THE USAGE AND THE OUTCOMES OF THE ANKLE JOINT REPLACEMENT.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 FROM THE MONTHLY REPORT OF FEBRUARY 2026. DURING THE REVIEW OF THE REPORT, IT WAS IDENTIFIED THAT A PATIENT REQUIRED REVISION SURGERY DUE TO LYSIS OF THE TIBIA AND TALUS WITH WEAR OF THE POLYETHYLENE COMPONENT, WHICH WAS NOT PREVIOUSLY REPORTED TO THE MANUFACTURER.

  Patient problems: Osteolysis

  MAUDE report 25015084 ↗
• 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  THE MANUFACTURER RECEIVED A REPORT FROM THE NATIONAL JOINT REGISTRY THAT CONTAINS UNPUBLISHED COLLECTED DATA ON THE USAGE AND THE OUTCOMES OF THE ANKLE JOINT REPLACEMENT.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 (B)(6) 2026. DURING THE REVIEW OF THE REPORT, IT WAS IDENTIFIED THAT A PATIENT REQUIRED REVISION SURGERY DUE TO STIFFNESS AND SOFT TISSUE IMPINGEMENT WHICH WAS NOT PREVIOUSLY REPORTED TO THE MANUFACTURER.

  Patient problems: Capsular Contracture; Joint Impingement

  MAUDE report 24544116 ↗
• InjuryMar 9, 2026Loss 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 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 ASEPTIC LOOSENING OF TIBIAL COMPONENT WHICH WAS NOT PREVIOUSLY REPORTED TO THE MANUFACTURER.

  Patient problems: Osteolysis

  MAUDE report 24543935 ↗
• InjuryJan 5, 2026Osseointegration Problem

  THE DIGITAL STRYKER PROPHECY TEAM RECEIVED A CT SCAN INDICATING THAT THE PATIENT MAY REQUIRE A REVISION SURGERY DUE TO WORSENING PAIN AFTER BEING MONITORED FOR CYSTIC CHANGES FOR OVER 1 YEAR. THE LOOSENING OF THE IMPLANTS HAS PROGRESSED.

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

  MAUDE report 23968586 ↗
• InjuryNov 19, 2025Loss of Osseointegration; Loss of Osseointegration

  IT WAS REPORTED BY THE CUSTOMER THAT THE PATIENT REQUIRED A REVISION SURGERY BECAUSE OF A STAGED REVISION APPROACH, REQUIRING THE IMPLANTING A CEMENT SPACER DUE TO PERITIBIAL CYSTIC LOOSENING WITH INFECTION. THE TIBIAL COMPONENT DEMONSTRATED LOOSENING. WITH THE TALAR COMPONENTS THE MORSE TAPER BETWEEN THE TALAR DOME AND THE TALAR STEM HAD NOT BEEN PROPERLY ENGAGED AND INSPECTION AFTER REMOVAL OF THE TALAR STEM REVEALED DELAMINATION OF THE PLASMA COATING.

  Patient problems: Inadequate Osseointegration; Medical device site infection

  MAUDE report 23596190 ↗
• InjuryNov 5, 2025Insufficient Device Problem Information; Insufficient Device Problem Information

  THE DIGITAL STRYKER PROPHECY TEAM RECEIVED A CT SCAN INDICATING THAT THE PATIENT MAY REQUIRE A REVISION SURGERY. THE PRIMARY IMPLANT CONSISTED OF A TIBIAL TRAY AND TALAR DOME. THE PATIENT LATER REQUIRED REMOVAL OF THE IMPLANT AND PLACEMENT OF AN ANTIBIOTIC CEMENT SPACER DUE TO SUSPECTED INFECTION, ALONG WITH NOTED POOR BONE QUALITY AND A LARGE BONE CYST SUPERIOR TO THE TIBIAL TRAY.

  Patient problems: Arthritis; Cyst(s); Inadequate Osseointegration; Post Operative Wound Infection

  MAUDE report 23480143 ↗
• InjurySep 15, 2025Osseointegration Problem; Osseointegration Problem

  THE DIGITAL STRYKER PROPHECY TEAM RECEIVED A CT SCAN INDICATING THAT THE PATIENT MAY REQUIRE A REVISION SURGERY OF BOTH THE TIBIAL AND TALAR COMPONENTS DUE TO POSSIBLE LOOSENING.

  Patient problems: Cyst(s); Inadequate Osseointegration

  MAUDE report 23057679 ↗
• InjuryAug 7, 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) 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 22735536 ↗
• 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) 2024 A PATIENT REQUIRED REVISION SURGERY DUE TO INFECTION & PERIPROSTHETIC FRACTURE, WHICH WAS NOT PREVIOUSLY REPORTED TO THE MANUFACTURER. REVISION PROCEDURE TYPE- STAGE 2 OF 2 STAGE REVISION.

  Patient problems: Bone Fracture(s); Unspecified Infection

  MAUDE report 22059332 ↗
• 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 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 INFECTION - ACTIVE WHICH WAS NOT PREVIOUSLY REPORTED TO THE MANUFACTURER.

  Patient problems: Unspecified Infection

  MAUDE report 22029943 ↗
• InjuryMay 7, 2025Break; Fracture; Break; Fracture

  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 IMPLANT FRACTURE OF MENISCAL COMPONENT, WEAR OF POLYETHYLENE COMPONENT, AND SOFT TISSUE IMPINGEMENT WHICH WAS NOT PREVIOUSLY REPORTED TO THE MANUFACTURER. SINGLE STAGE REVISION, INCLUDES DAIR WITH MODULAR EXCHANGE AND MODULAR EXCHANGE FOR INDICATIONS OTHER THAN INFECTION.

  Patient problems: Failure of Implant; Joint Impingement

  MAUDE report 21975715 ↗
• 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) 2024 A PATIENT REQUIRED REVISION SURGERY DUE TO LYSIS OF TIBIA AND INFECTION WHICH WAS NOT PREVIOUSLY REPORTED TO THE MANUFACTURER.

  Patient problems: Osteolysis; Unspecified Infection

  MAUDE report 21644171 ↗
• InjuryMar 14, 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. PATIENT PRESENTED WITH LYMPHOEDEMA FOLLOWING RIGHT TOTAL ANKLE REPLACEMENT AND PREVIOUS HINDFOOT TRIPLE FUSION. CLINICIAN RECOMMENDED THAT PATIENT SHOULD FOCUS ON WEIGHT LOSS AND REDUCE BMI AS THEY WERE WORRIED ABOUT GOING THROUGH A LARGE PROCEDURE LIKE KNEE REPLACEMENT BECAUSE OF THEIR BMI AND REHABILITATION."

  Patient problems: Seroma

  MAUDE report 21606325 ↗
• 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) 2023 A PATIENT REQUIRED REVISION SURGERY DUE TO MALALIGNMENT, WHICH WAS NOT PREVIOUSLY REPORTED TO THE MANUFACTURER.

  Patient problems: Joint Impingement; Subluxation

  MAUDE report 21535808 ↗
• InjuryFeb 12, 2025Migration; Migration

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

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

  MAUDE report 21362490 ↗
• 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) 2020 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 20901651 ↗
• 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 STIFFNESS WHICH WAS NOT PREVIOUSLY REPORTED TO THE MANUFACTURER.

  Patient problems: Loss of Range of Motion

  MAUDE report 20901643 ↗
• 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, MALALIGNMENT & SOFT TISSUE IMPINGEMENT, WHICH WAS NOT PREVIOUSLY REPORTED TO THE MANUFACTURER.

  Patient problems: Joint Impingement; Subluxation; Unspecified Infection

  MAUDE report 20901641 ↗
• InjuryDec 4, 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) 2022 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 20840941 ↗
• InjuryNov 27, 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 UNEXPLAINED PAIN, STIFFNESS, WHICH WAS NOT PREVIOUSLY REPORTED TO THE MANUFACTURER.

  Patient problems: Implant Pain; Loss of Range of Motion

  MAUDE report 20801083 ↗
• InjuryNov 8, 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) 2018 ¿ (B)(6) 2023. DURING THE REVIEW OF THE REPORT, IT WAS IDENTIFIED THAT ON (B)(6)2018 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 20637084 ↗
• InjuryOct 30, 2024Insufficient Device Problem Information; Insufficient Device Problem Information

  THE DIGITAL STRYKER PROPHECY TEAM RECEIVED A CT SCAN INDICATING THAT THE PATIENT MAY REQUIRE A REVISION SURGERY FOR REASONS THAT ARE NOT AVAILABLE AT THE TIME OF THIS REPORT.

  Patient problems: Insufficient Information

  MAUDE report 20572015 ↗
• InjuryOct 28, 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: 200-004. PATIENT HAD NUMBNESS."

  Patient problems: Numbness

  MAUDE report 20543328 ↗
• InjurySep 25, 2024Material Separation; Material Separation

  IT WAS REPORTED THAT THE UPON REMOVING INFINITY ANKLE AND IMPLANTING VALOR NAIL, THE SURGEON NOTICED METALLOSIS IN THE SURROUNDING TISSUE. UPON REMOVAL OF THE TIBIAL TRAY THERE WAS AN AREA OF DELAMINATION VISIBLE.

  Patient problems: Failure of Implant; Impaired Healing; Metal Related Pathology

  MAUDE report 20306096 ↗