INFINITY 33650001Recalls & reported problems

Summary

The FDA's MAUDE database contains 13 adverse event reports that list this exact device (DI 00840420122483), received between Dec 16, 2021 and Feb 27, 2026 — classified as 13 injuries.

The most frequently reported specific device problem is “Osseointegration Problem” (4 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. 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 13 most recent of 13 reports, in the reporter's own words as published by the FDA.

• 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 24469195 ↗
• InjuryDec 1, 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  THE MANUFACTURER RECEIVED A REPORT FROM THE NATIONAL JOINT REGISTRY THAT CONTAINS UNPUBLISHED COLLECTED DATA ON THE USAGE AND THE OUTCOMES OF THE ANKLE JOINT REPLACEMENT.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 2022 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 OF TIBIAL COMPONENT, WHICH WAS NOT PREVIOUSLY REPORTED TO THE MANUFACTURER.

  Patient problems: Osteolysis

  MAUDE report 23687243 ↗
• InjuryJul 15, 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: Cyst(s); Inadequate Osseointegration

  MAUDE report 22514968 ↗
• 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  THE MANUFACTURER RECEIVED A REPORT FROM THE NATIONAL JOINT REGISTRY THAT CONTAINS UNPUBLISHED COLLECTED DATA ON THE USAGE AND THE OUTCOMES OF THE ANKLE JOINT REPLACEMENT.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 21468940 ↗
• 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) 2019 A PATIENT REQUIRED REVISION DUE TO ASEPTIC LOOSENING - TIBIAL COMPONENT, WHICH WAS NOT PREVIOUSLY REPORTED TO THE MANUFACTURER.

  Patient problems: Inadequate Osseointegration

  MAUDE report 20426340 ↗
• InjuryJun 28, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT MAY NEED TO UNDERGO A REVISION SURGERY DUE TO INCREASED PAIN AND SWELLING 6- 8 MONTHS POST-OP. THE PATIENT'S INFECTION WORK UP HAS BEEN NEGATIVE.

  Patient problems: Cyst(s); Implant Pain; Swelling/ Edema

  MAUDE report 19636342 ↗
• InjuryJun 30, 2023Osseointegration Problem; Osseointegration Problem

  THE PATIENT IS SEEKING COMPENSATION TO ADDRESS THE SURGERY SHE IS GOING TO NEED TO HAVE. PATIENT HAD THIS SURGERY BECAUSE SHE HAD "DEAD BONE" IN HER FOOT. PATIENT NOTICED ISSUES WITH HER ANKLE A COUPLE MONTHS POST THE PROCEDURE. THE PATIENT HAD A WRIGHT MEDICAL ANKLE REPLACEMENT IMPLANTED IN NOVEMBER 2016 AND NOW THE BUSHING IS LOOSE. DOCTOR DID X-RAYS LAST WEEK AND NOTICED THE DIFFERENCE BETWEEN THE POST-OP X-RAYS AND THE X-RAYS THAT WERE TAKEN LAST WEEK. PATIENT REPORTS THAT THE DOCTOR STATES THAT HE HAS "NEVER SEEN THIS HAPPEN BEFORE". PATIENT USES A CANE TO WALK AND IS IN A LOT OF PAIN AND THE ANKLE IS SWOLLEN AND THIS PROCEDURE HAS AFFECTING EVERY ASPECT OF HER LIFE. PATIENT MAINTAINS SHE ADHERED TO ALL MOBILITY INSTRUCTIONS PROVIDED BY THE PHYSICIAN POST OPERATIVELY.

  Patient problems: Ambulation or Postural Difficulties; Extraskeletal ossification; Implant Pain; Inadequate Osseointegration; Swelling/ Edema

  MAUDE report 17238895 ↗
• InjuryAug 30, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PATIENT UNDERWENT A TOTAL ANKLE REPLACEMENT SURGERY. ALLEGEDLY, THE PATIENT MAY NEED TO UNDERGO A REVISION SURGERY DUE TO REASONS THAT WERE NOT AVAILABLE AT THE TIME OF THIS REPORT.

  Patient problems: Insufficient Information

  MAUDE report 15324261 ↗
• InjuryJul 18, 2022Adverse 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 FOR REASON NOT AVAILABLE AT THE TIME OF THIS REPORT.

  Patient problems: Insufficient Information

  MAUDE report 15041222 ↗
• InjuryJul 12, 2022Adverse 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 FOR REASONS THAT ARE NOT AVAILABLE AT THE TIME OF THIS REPORT.

  Patient problems: Insufficient Information

  MAUDE report 14989184 ↗
• InjuryJun 20, 2022Adverse 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 FOR REASONS THAT ARE NOT AVAILABLE AT THE TIME OF THIS REPORT.

  Patient problems: Insufficient Information

  MAUDE report 14745219 ↗
• 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 14465855 ↗
• InjuryDec 16, 2021Adverse Event Without Identified Device or Use Problem; Migration; Adverse Event Without Identified Device or Use Problem; Migration

  PREVIOUS TOTAL ANKLE REPLACEMENT IMPLANTED. THE PATIENT HAS DEVELOP A MEDIAL MALLEOLAR STRESS FRACTURE AND THE TIBIAL IMPLANT HAS SUBSIDED AND IS NOW IN A TILT. THE PATIENT NEEDS TO BE REVISED TO A INVISION REVISION IMPLANT AND THIS IS BOOKED FOR EARLY 2022.

  Patient problems: Bone Fracture(s)

  MAUDE report 13019335 ↗