INFINITY 33630021Recalls & reported problems

Summary

The FDA's MAUDE database contains 10 adverse event reports that list this exact device (DI 00840420122025), received between May 21, 2022 and Jun 8, 2026 — classified as 10 injuries.

The most frequently reported specific device problem is “Osseointegration Problem” (1 report).

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. What reports can and can't tell you · How this data works · Data updated Oct 16, 2026.

Most reported problems

Recent adverse event reports

The 10 most recent of 10 reports, in the reporter's own words as published by the FDA.

• 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  THE MANUFACTURER RECEIVED A REPORT FROM THE NATIONAL JOINT REGISTRY THAT CONTAINS UNPUBLISHED COLLECTED DATA ON THE USAGE AND THE OUTCOMES OF THE ANKLE JOINT REPLACEMENT.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 25426051 ↗
• InjuryFeb 27, 2026Adverse Event Without Identified Device or Use Problem

  SUBJECT: (B)(6). UK INFINITY TOTAL ANKLE SYSTEM STUDY. LUMP AND SWELLING TO ANKLE. CT REQUESTED (B)(6) 2025 DUE TO SYMPTOMS.

  Patient problems: Swelling/ Edema

  MAUDE report 24469197 ↗
• InjuryDec 17, 2025Osseointegration Problem; Osseointegration Problem

  THE DIGITAL STRYKER PROPHECY TEAM RECEIVED A CT SCAN INDICATING THAT THE PATIENT MAY REQUIRE A REVISION SURGERY DUE TO THE TALUS IS CAUSING THE PATIENT A LOT OF PAIN AND APPEARS TO BE LOOSENING.

  Patient problems: Ambulation or Postural Difficulties; Inadequate Osseointegration; Pain

  MAUDE report 23831951 ↗
• 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  THE MANUFACTURER RECEIVED A REPORT FROM THE NATIONAL JOINT REGISTRY THAT CONTAINS UNPUBLISHED COLLECTED DATA ON THE USAGE AND THE OUTCOMES OF THE ANKLE JOINT REPLACEMENT.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 23335083 ↗
• 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 UNEXPLAINED PAIN AND STIFFNESS WHICH WAS NOT PREVIOUSLY REPORTED TO THE MANUFACTURER.

  Patient problems: Loss of Range of Motion; Pain

  MAUDE report 22030164 ↗
• InjuryMay 6, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  AS REPORTED: SUBJECT: 925-005 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 21966439 ↗
• InjuryFeb 26, 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 JANUARY 2025. DURING THE REVIEW OF THE REPORT, IT WAS IDENTIFIED THAT ON (B)(6) 2024 A PATIENT REQUIRED REVISION SURGERY DUE TO STIFFNESS, WHICH WAS NOT PREVIOUSLY REPORTED TO THE MANUFACTURER. REVISION PROCEDURE TYPE: SINGLE STAGE REVISION (INCLUDES DAIR WITH MODULAR EXCHANGE AND MODULAR EXCHANGE FOR INDICATIONS OTHER THAN INFECTION).

  Patient problems: Loss of Range of Motion

  MAUDE report 21468937 ↗
• 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 STIFFNESS, SOFT TISSUE IMPINGEMENT, WHICH WAS NOT PREVIOUSLY REPORTED TO THE MANUFACTURER.

  Patient problems: Joint Impingement; Loss of Range of Motion

  MAUDE report 20854284 ↗
• 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 19404038 ↗
• InjuryMay 21, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT UNDERWENT A PROPHECY INFINITY ANKLE IMPLANT SURGERY. FIVE YEARS LATER, THE PATIENT IS EXPERIENCING PAIN IN THE JOINT AND NEEDING A REVISION.

  Patient problems: Implant Pain

  MAUDE report 14465632 ↗