INFINITY 33653306Recalls & reported problems

Summary

The FDA's MAUDE database contains 22 adverse event reports that list this exact device (DI 00840420122704), received between Nov 29, 2021 and Aug 18, 2026 — classified as 22 injuries.

The most frequently reported specific device problem is “Osseointegration Problem” (5 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 22 most recent of 22 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  The manufacturer received a report from the National Joint Registry that contains unpublished collected data on the usage and the outcomes of the ankle joint replacement.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 (b)(6) 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 50295409 ↗
• InjuryNov 11, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE DIGITAL STRYKER PROPHECY TEAM RECEIVED A CT SCAN INDICATING THAT THE PATIENT MAY REQUIRE A REVISION SURGERY DUE TO ONGOING PAIN WITH WEIGHT BEARING AND THERE IS SOME OSTEOLYSIS BONE CYSTS UNDER THE TALAR COMPONENT.

  Patient problems: Cyst(s); Osteolysis; Pain

  MAUDE report 23525687 ↗
• 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  THE MANUFACTURER RECEIVED A REPORT FROM THE NATIONAL JOINT REGISTRY THAT CONTAINS UNPUBLISHED COLLECTED DATA ON THE USAGE AND THE OUTCOMES OF THE ANKLE JOINT REPLACEMENT.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 22029942 ↗
• 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-(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 22025585 ↗
• 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 ON (B)(6) 2025. UPDATE DATED 07 MAY 2025: SURGICAL INTERVENTION OCCURRED ON (B)(6) 2025 AS SCHEDULED. NO IMPLANT REMOVED. "

  Patient problems: Pain

  MAUDE report 22020806 ↗
• 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 21948104 ↗
• InjuryApr 29, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use 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 FOR REASONS OF INFECTION.

  Patient problems: Medical device site infection

  MAUDE report 21927916 ↗
• InjuryApr 3, 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) 2024 A PATIENT REQUIRED REVISION SURGERY DUE TO UNEXPLAINED PAIN, STIFFNESS AND SOFT TISSUE IMPINGEMENT, WHICH WAS NOT PREVIOUSLY REPORTED TO THE MANUFACTURER.

  Patient problems: Capsular Contracture; Joint Impingement; Pain

  MAUDE report 21764862 ↗
• InjuryMar 10, 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 REPORTED IN (B)(6) 2024. DURING THE REVIEW OF THE REPORT, IT WAS IDENTIFIED THAT ON (B)(6) 2024 A PATIENT REQUIRED REVISION SURGERY DUE TO ASEPTIC LOOSENING & LYSIS OF TIBIAL COMPONENTS, WHICH WAS NOT PREVIOUSLY REPORTED TO THE MANUFACTURER. TYPE OF REVISION: STAGE 2 OF 2 STAGE REVISION.

  Patient problems: Inadequate Osseointegration; Osteolysis

  MAUDE report 21566079 ↗
• InjuryJan 27, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

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

  Patient problems: Unspecified Infection

  MAUDE report 21248811 ↗
• InjuryDec 5, 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) 2021 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 20854105 ↗
• 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 20853244 ↗
• 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) 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 20637686 ↗
• 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 (B)(6) 2018 ¿ (B)(6) 2023. DURING THE REVIEW OF THE REPORT, IT WAS IDENTIFIED THAT ON (B)(6) 2020 A PATIENT REQUIRED REVISION SURGERY DUE TO ASEPTIC LOOSENING AND COMPONENT MIGRATION/DISSOCIATION , WHICH WAS NOT PREVIOUSLY REPORTED TO THE MANUFACTURER.

  Patient problems: Inadequate Osseointegration

  MAUDE report 20472707 ↗
• 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)(6) 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 20472615 ↗
• 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 (B)(6) 2018 ¿ (B)(6) 2023. DURING THE REVIEW OF THE REPORT, IT WAS IDENTIFIED THAT ON (B)(6) 2021 A PATIENT REQUIRED REVISION DUE TO ASEPTIC LOOSENING, WHICH WAS NOT PREVIOUSLY REPORTED TO THE MANUFACTURER.

  Patient problems: Inadequate Osseointegration

  MAUDE report 20426061 ↗
• InjurySep 11, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  AS REPORTED: MEDIAL ANKLE PAIN, IMPINGEMENT. (B)(6) 2021: POSSIBLE BONE IMPINGEMENT TO MEDIAL GUTTER TAR SHOWED NO SIGN OF INFECTION OR LUCENCY. NO IMPLANTS REMOVED. MEDIAL GUTTER SCOPE + OPEN DEBRIDEMENT. (B)(6) 2021: IMPROVING. FURTHER FOLLOW UP PENDING. (B)(6) 2023: RESOLVED."

  Patient problems: Implant Pain; Joint Impingement

  MAUDE report 20188477 ↗
• InjuryAug 15, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  SUBJECT: (B)(6). STUDY: UK INFINITY TOTAL ANKLE SYSTEM. ADVERSE EVENT TERM: FRACTURE MEDIAL MALLEOLUS - HEALED. NARRATIVE OF ADVERSE EVENT: FRACTURE SEEN ON 6 MONTH POST OP X-RAY, PATIENT ASYMPTOMATIC.

  Patient problems: Bone Fracture(s)

  MAUDE report 19993275 ↗
• InjuryJun 5, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  AS REPORTED: "PATIENT FOUND TO BE STIFF IN DORSIFLEXION WITH ANTERIOR PAIN AND LIMITED ROM ON FLUOROSCOPY (TO LESS THAN PLANTIGRADE). PERCUTANEOUS ACHILLES TENOTOMY PERFORMED AND DORSIFLEXION IMPROVED TO 10 DEGREES".

  Patient problems: Implant Pain; Loss of Range of Motion

  MAUDE report 19467881 ↗
• InjuryAug 1, 2023Adverse Event Without Identified Device or Use Problem; Insufficient Device Problem Information; Adverse Event Without Identified Device or Use Problem; Insufficient Device Problem Information

  THE DIGITAL STRYKER PROPHECY TEAM RECEIVED A CT SCAN INDICATING THAT THE PATIENT PRESENTED WITH GASTRIC RECESSION AND GUTTER DEBRIDEMENT. THE REASON FOR REVISION IS GASTRIC RECESSION AND GUTTER DEBRIDEMENT. THE SURGEON DOES NOT SUSPECT ANY IMPLANT LOOSENING.

  Patient problems: Insufficient Information

  MAUDE report 17432313 ↗
• InjuryDec 2, 2022Adverse Event Without Identified Device or Use Problem; Insufficient Device Problem Information; Adverse Event Without Identified Device or Use Problem; Insufficient Device Problem Information

  IT WAS REPORTED THAT THE PATIENT UNDERWENT A TOTAL ANKLE REPLACEMENT. THE PHYSICIAN PLANS ON CLEANING OUT THE GUTTERS AND SWAPPING OUT THE POLY. ALLEGEDLY, THE PATIENT MAY NEED TO UNDERGO A REVISION SURGERY FOR REASONS THAT ARE NOT AVAILABLE AT THE TIME OF THIS REPORT.

  Patient problems: Insufficient Information

  MAUDE report 15911300 ↗
• InjuryNov 29, 2021Adverse 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 SURGERY. APPROXIMATELY 6 MONTHS POST-OP THE PATIENT EXPERIENCED PAIN AND WAS EVALUATED FOR INFECTION AND STABILIZED AT 1 YEAR POST-OP. APPROXIMATELY 2 YEARS POST-OP HAD SWELLING AND PAIN. THE SURGEON STATED THAT HE HAD RECOMMENDED SURGERY BEFORE BUT DUE TO THE PATIENTS UNSTABLE MENTAL STATUS THE PATIENT ELECTED NOT TO AGREE TO THE SURGERY. 32 MONTHS POST-OP THE PATIENT UNDERWENT A REVISION IN WHICH THE IMPLANTS WERE REMOVED AND A FUSION PROCEDURE WAS PERFORMED. SURGEON REPORTED ISOLATED STAPH CAPITUS FROM SEVERAL SAMPLES TAKEN AT THE TIME OF REVISION.

  Patient problems: Bacterial Infection; Pain; Swelling/ Edema

  MAUDE report 12883155 ↗