INBONE 220220904Recalls & reported problems

Summary

The FDA's MAUDE database contains 14 adverse event reports that list this exact device (DI 00840420124234), received between Dec 27, 2022 and Jul 16, 2026 — classified as 14 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 14 most recent of 14 reports, in the reporter's own words as published by the FDA.

• InjuryJul 16, 2026Unstable

  SUBJECT: (B)(6). UK INFINITY® TOTAL ANKLE SYSTEM STUDY. ON (B)(6) 2018 INSTABILITY IN RIGHT ANKLE WITH ONGOING PAIN VERY POOR BONE QUALITY. LACK OF BONE INTEGRATION INTO PRODENSE GRAFTING IN THE RIGHT ANKLE. STRONG HISTORY OF INFECTION IN KNEE. PATIENT WAS DUE TO BE ADMITTED TO RULE OUT POOR BONE INTEGRATION VERSUS INFECTION IN THE ANKLE, HOWEVER PATIENT DID NOT WISH TO PROCEED.

  Patient problems: Joint Laxity; Pain; Unspecified Infection

  MAUDE report 25841021 ↗
• 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  THE MANUFACTURER RECEIVED A REPORT FROM THE NATIONAL JOINT REGISTRY THAT CONTAINS UNPUBLISHED COLLECTED DATA ON THE USAGE AND THE OUTCOMES OF THE ANKLE JOINT REPLACEMENT.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 TALAR COMPONENT, WHICH WAS NOT PREVIOUSLY REPORTED TO THE MANUFACTURER.

  Patient problems: Osteolysis

  MAUDE report 24543941 ↗
• InjuryJan 15, 2026Osseointegration Problem

  THE DIGITAL STRYKER PROPHECY TEAM RECEIVED A CT SCAN INDICATING THAT THE PATIENT MAY REQUIRE A REVISION SURGERY DUE TO ASEPTIC LOOSENING OF INBONE TALUS COMPONENT. THE INFINITY TIBIA IS WELL FIXED. I NEED TO REVISE TO AN INVISION TALUS FOR SCREW OPTIONS IN PLATE SO MY UNDERSTANDING IS I WILL NEED TO REMOVE THE WELL-FIXED INFINITY TIBIAL COMPONENT AS THE POLY WON¿T MATCH THE INVISION TALUS.

  Patient problems: Inadequate Osseointegration

  MAUDE report 24088983 ↗
• InjuryDec 1, 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 UNEXPLAINED PAIN, WHICH WAS NOT PREVIOUSLY REPORTED TO THE MANUFACTURER.

  Patient problems: Pain

  MAUDE report 23687103 ↗
• 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 23053535 ↗
• 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: (B)(6). PATIENT BLEEDING FROM LEFT ANKLE WOUND. PATIENT BECAME HYPOTENSIVE. 64/47- 1000MLS CRYSTALLOID ADMINISTERED AND BLOOD PRESSURE IMPROVED TO 78/59. PATIENT ALSO POSITIONED HEAD DOWN. PLASTER CUT AND PRESSURE AND COLD COMPRESS APPLIED TO BLEEDING POINT. BLEEDING STOPPED AND BLOOD PRESSURE IMPROVED WITH BLOOD TRANSFUSION AND CRYSTALLOID REPLACEMENT."

  Patient problems: Wound Dehiscence

  MAUDE report 20543319 ↗
• InjuryFeb 28, 2024Adverse 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 MAY REQUIRE A REVISION SURGERY DUE TO INDICATION OF CHRONICALLY PAINFUL TOTAL ANKLE AND PRESUMED ASEPTIC LOOSENING. JOINT ASPIRATION CULTURES NEGATIVE. JOINT FLUID SYNOVASURE NEGATIVE. BASED ON EXAM, SERIAL RADIOGRAPHS OVER THE PAST 18 MONTHS AND SPECT-CT, REASONABLE SUSPICION FOR AT LEAST TALAR COMPONENT LOOSENING. THE PHYSICIAN INTENDS TO REVISE TALUS, AT A MINIMUM, BUT WILL ASSESS TIBIAL COMPONENT STABILITY INTRAOPERATIVELY.

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

  MAUDE report 18800995 ↗
• InjuryFeb 19, 2024Adverse 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 UNDERWENT A REVISION PROCEDURE DUE TO A PERI PROSTHETIC FRACTURE.

  Patient problems: Limb Fracture; Unspecified Infection

  MAUDE report 18735802 ↗
• InjuryDec 13, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT UNDERWENT A RIGHT ANKLE SURGERY ON (B)(6) 2015, AND WAS IMPLANTED WITH WRIGHT INBONE ANKLE SYSTEM. IN THE LAST FOUR YEARS, THE PATIENT HAS ALLEGEDLY BEEN PLAGUED WITH INFECTIONS AT THE SURGICAL SITE IN THE RIGHT ANKLE. THE PATIENT IS SCHEDULED FOR REVISION SURGERY.

  Patient problems: Unspecified Infection

  MAUDE report 18322866 ↗
• InjurySep 29, 2023Insufficient Device Problem Information; Appropriate Device Problem Term/Code Not Available; Insufficient Device Problem Information; Appropriate Device Problem Term/Code Not Available

  THE DIGITAL STRYKER PROPHECY TEAM RECEIVED A CT SCAN INDICATING THAT THE PATIENT MAY REQUIRE A REVISION SURGERY DUE TO PAIN AND POSSIBLE LOOSENING/CYSTIC CHANGES.

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Implant Pain

  MAUDE report 17848118 ↗
• InjurySep 8, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT HAD TO UNDERGO A REVISION SURGERY DUE TO THE INFECTION.

  Patient problems: Limb Fracture; Osteolysis; Unspecified Infection

  MAUDE report 17712623 ↗
• InjuryAug 4, 2023Osseointegration Problem; Osseointegration Problem

  IT WAS REPORTED THAT THE PATIENT UNDERWENT A REVISION SURGERY OF INBONE TALUS DUE TO LOOSENING. THE PATIENT WAS IMPLANTED WITH INVISION TALUS AND LEFT INVISION PEG TALAR PLATE.

  Patient problems: Cyst(s); Inadequate Osseointegration

  MAUDE report 17465817 ↗
• InjuryMar 3, 2023Migration; Migration

  IT WAS REPORTED THAT THE PATIENT UNDERWENT A TOTAL ANKLE REPLACEMENT. UPON A CT SCAN IT WAS NOTED THAT THERE WAS CYSTIC FORMATION AROUND BOTH TIBIAL AND TALUS COMPONENTS. EXPECTED LOOSENING OF BOTH COMPONENTS. NO FOLLOW UP PROCEDURES.

  Patient problems: Bone Fracture(s); Cyst(s); Inadequate Osseointegration

  MAUDE report 16479909 ↗
• InjuryDec 27, 2022Inadequacy of Device Shape and/or Size; Migration; Inadequacy of Device Shape and/or Size; Migration

  IT WAS REPORTED THAT THE PATIENT UNDERWENT A TOTAL ANKLE REPLACEMENT. THE PATIENT COMPLAINED OF PAIN. ALLEGEDLY, THE PATIENT MAY NEED TO UNDERGO A REVISION SURGERY FOR IMPLANT LOOSENING LIKELY CAUSED BY PATIENT ANATOMY.

  Patient problems: Failure of Implant; Implant Pain

  MAUDE report 16057833 ↗