INFINITY 33650013Recalls & reported problems

Summary

The FDA's MAUDE database contains 44 adverse event reports that list this exact device (DI 00840420122544), received between Aug 12, 2021 and Aug 18, 2026 — classified as 44 injuries.

The most frequently reported specific device problem is “Osseointegration Problem” (13 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 44 reports, in the reporter's own words as published by the FDA.

• InjuryAug 18, 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  The manufacturer received a report from the National Joint Registry that contains unpublished collected data on the usage and the outcomes of the ankle joint replacement.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 July 2026During 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 50295408 ↗
• InjuryAug 12, 2026Adverse Event Without Identified Device or Use Problem

  Subject: (b)(6).UK INFINITY Total Ankle System Study.Gutter pain:Increased pain reported around the ankle. Plain x rays show some potential gutter impingement. Spect CT scan ordered.

  Patient problems: Joint Impingement; Pain

  MAUDE report 50222419 ↗
• InjuryMar 4, 2026Osseointegration Problem; 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: Cyst(s); Inadequate Osseointegration; Insufficient Information; Pain

  MAUDE report 24513565 ↗
• InjuryDec 30, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  SUBJECT: (B)(6). UK INFINITY TOTAL ANKLE SYSTEM STUDY. ADVERSE EVENT TERM: : NEW PAIN IN ANKLE. NARRATIVE OF ADVERSE EVENT: : PREVIOUSLY PAIN FREE BUT FOR THE LAST COUPLE OF DAYS PATIENT HAS HAD PAIN IN ANKLE WHEN CLIMBING STAIRS. HAS MOVED HOUSE AND FLAT NOW ON THIRD FLOOR. ONCE SETTLED IN, PAIN HAS NOW COMPLETELY RESOLVED. PATIENT THINKS RELATED TO ADJUSTMENT TO INCREASED NUMBER STAIRS TO CLIMB.

  Patient problems: Pain

  MAUDE report 23919869 ↗
• 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 23803984 ↗
• 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 MALALIGNMENT, UNEXPLAINED PAIN AND STIFFNESS, WHICH WAS NOT PREVIOUSLY REPORTED TO THE MANUFACTURER.

  Patient problems: Loss of Range of Motion; Pain; Subluxation

  MAUDE report 23803979 ↗
• InjuryDec 1, 2025Loss of Osseointegration; Adverse Event Without Identified Device or Use Problem; Loss of Osseointegration; 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 2023 TO 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 IN TIBIAL COMPONENT AND LYSIS - TALUS, WHICH WAS NOT PREVIOUSLY REPORTED TO THE MANUFACTURER.

  Patient problems: Osteolysis

  MAUDE report 23687197 ↗
• InjuryNov 6, 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.

  Patient problems: Insufficient Information

  MAUDE report 23487771 ↗
• InjuryOct 28, 2025Adverse Event Without Identified Device or Use Problem; Osseointegration Problem; Adverse Event Without Identified Device or Use Problem; Osseointegration Problem

  THE DIGITAL STRYKER PROPHECY TEAM RECEIVED A CT SCAN INDICATING THAT THE PATIENT REQUIRED A REVISION SURGERY "FOR PAIN AND LUCENCIES AROUND THE IMPLANT ?INFECTION. DONE FOR POST-TRAUMATIC ARTHRITIS, PREVIOUS FRACTURE/ORIF/ROM. NO OBVIOUS PATIENT FACTORS BEYOND BEING A LITTLE OVERWEIGHT. BONE QUALITY WAS REASONABLY GOOD - A FEW CYSTIC AREAS AS PREDICTED. ACTIVITY LEVEL WAS RESTRICTED BY ANKLE SYMPTOMS. I THINK THE PATIENT WAS COMPLIANT WITH INSTRUCTIONS" THE PATIENT IS CURRENTLY IMPLANTED WITH A BONE CEMENT SPACER. IMAGING IDENTIFIED A POSTERIOR LINE FRACTURE PRESENT IN THE TIBIA AND RADIOPAQUE FEATURE IDENTIFIED IN THE TIBIA BONE (SCLEROTIC BONE). ADDITIONAL FEEDBACK FROM THE SURGEON STATED THAT "IT WOULD SEEM INFECTION IS NOT THE ISSUE CAUSING LOOSENING. IT DOESN¿T APPEAR TO BE INFECTION."

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

  MAUDE report 23407351 ↗
• InjuryAug 13, 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 2016 TO 2025. DURING THE REVIEW OF THE REPORT, IT WAS IDENTIFIED THAT ON (B)(6) 2025 A PATIENT REQUIRED REVISION SURGERY DUE TO COMPONENT MIGRATION/DISSOCIATION/STIFFNESS, WHICH WAS NOT PREVIOUSLY REPORTED TO THE MANUFACTURER.

  Patient problems: Inadequate Osseointegration; Loss of Range of Motion

  MAUDE report 22793317 ↗
• InjuryJun 18, 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 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 ASEPTIC LOOSENING OF TIBIAL AND TALAR COMPONENTS, WHICH WAS NOT PREVIOUSLY REPORTED TO THE MANUFACTURER.

  Patient problems: Osteolysis

  MAUDE report 22282756 ↗
• InjuryMay 16, 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 BETWEEN APRIL 2023 - JULY 2024. DURING THE REVIEW OF THE REPORT, IT WAS IDENTIFIED THAT ON (B)(6) 2024 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 22038951 ↗
• 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 MALALIGNMENT AND SOFT TISSUE IMPINGEMENT WHICH WAS NOT PREVIOUSLY REPORTED TO THE MANUFACTURER.

  Patient problems: Joint Impingement; Subluxation

  MAUDE report 22029939 ↗
• InjuryMay 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 STUDY. INCREASED PAIN AROUND MEDIAL SIDE OF ANKLE PARTICIPANT JUMPED TO AVOID STRAY GOLF BALL LAST MONTH AND LANDED AWKWARDLY ON ANKLE. INTERMITTENT PAIN HAS BECOME REGULAR AROUND MEDIAL ANKLE AND INCREASED SWELLING. X-RAY SHOWS 'NOTHING UNTOWARD' WITH IMPLANT AND PARTICIPANT LISTED FOR CLEARING MEDIAL GUTTER OF BONE DUE (B)(6) 2025. UPDATE DATED (B)(6) 2025: SURGICAL INTERVENTION OCCURRED ON (B)(6) 2025 AS SCHEDULED. NO IMPLANT REMOVED. "

  Patient problems: Pain

  MAUDE report 22020805 ↗
• InjuryMay 2, 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: (B)(6). EXCESSIVE PAIN & SWELLING LEFT ANKLE. SLIGHT ERYTHEMA IN THE ANTERIOR ASPECT OF LEFT LOWER LEG WITH SLIGHT TENDERNESS ON PALPITATION. INFECTION. PERSISTENT SWELLING. PATIENT REQUIRED MEDICATION AND SURGERY."

  Patient problems: Bacterial Infection; Implant Pain; Swelling/ Edema

  MAUDE report 21948100 ↗
• InjuryApr 25, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PATIENT NEEDED TO USE PROSTHESIS DURING THE ANKLE REPLACEMENT, AND THE TIBIAL PAD WAS USED DURING THE PROCEDURE, AND THE REPLACEMENT RESULTS WERE GOOD. LATER AFTER 1 MONTH THE INCISION WAS PERMEATED AND THE HEALING WAS POOR. RE-ADMITTED TO HOSPITAL FOR DEBRIDEMENT, ANTIBIOTIC BONE CEMENT PLACEMENT, VSD ASPIRATION. POSTOPERATIVE WOUND RECOVERY WAS OK.

  Patient problems: Impaired Healing; Post Operative Wound Infection

  MAUDE report 21911991 ↗
• InjuryApr 7, 2025Osseointegration Problem; Osseointegration Problem

  THE DIGITAL STRYKER PROPHECY TEAM RECEIVED A CT SCAN INDICATING THAT THE PATIENT MAY REQUIRE A REVISION SURGERY OF TIBIAL COMPONENT FOR REASON OF ASEPTIC LOOSENING.

  Patient problems: Inadequate Osseointegration

  MAUDE report 21786709 ↗
• 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 UNEXPECTED PAIN, WHICH WAS NOT PREVIOUSLY REPORTED TO THE MANUFACTURER.

  Patient problems: Implant Pain

  MAUDE report 21535814 ↗
• InjuryMar 5, 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 REPORTED IN MARCH 2024. DURING THE REVIEW OF THE REPORT, IT WAS IDENTIFIED THAT ON (B)(6) 2024 A PATIENT REQUIRED REVISION SURGERY DUE TO MALALIGNMENT, WHICH WAS NOT PREVIOUSLY REPORTED TO THE MANUFACTURER. TYPE OF REVISION: SINGLE STAGE REVISION.

  Patient problems: Joint Impingement; Subluxation

  MAUDE report 21525016 ↗
• InjuryFeb 21, 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 ASEPTIC LOOSENING OF TALAR COMPONENT , WHICH WAS NOT PREVIOUSLY REPORTED TO THE MANUFACTURER. REVISION PROCEDURE TYPE: ANKLE FUSION (SUBTALAR JOINT NOT FUSED AT THIS SITTING).

  Patient problems: Inadequate Osseointegration

  MAUDE report 21432333 ↗
• 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 20853226 ↗
• 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) 2018 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 20853100 ↗
• 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) 2023 A PATIENT REQUIRED REVISION SURGERY DUE TO INFECTION, WHICH WAS NOT PREVIOUSLY REPORTED TO THE MANUFACTURER.

  Patient problems: Unspecified Infection

  MAUDE report 20840938 ↗
• InjuryOct 17, 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)(4) 2021 A PATIENT REQUIRED REVISION SURGERY DUE TO ASEPTIC LOOSENING & COMPONENT MIGRATION/ DISSOCIATION, WHICH WAS NOT PREVIOUSLY REPORTED TO THE MANUFACTURER.

  Patient problems: Inadequate Osseointegration; Joint Impingement; Osteolysis; Subluxation

  MAUDE report 20472420 ↗
• 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 20426262 ↗