INBONE 200010902Recalls & reported problems
Wright Medical Technology, Inc. · Class 2 · Implant
Data updated Oct 13, 2026 from official FDA records · Editorial policy
Quick summary
This INBONE ankle replacement is an implanted artificial ankle joint. Reports mostly describe loosening or poor bonding to bone, with pain, infection and cysts, often leading to revision or removal surgery. There are 24 reports naming its identifier, with no deaths and 23 injuries. No recalls name this device.
AI-generated from the FDA records on this page and checked automatically against the numbers below. Read the details before relying on it.
- Adverse event reports
- 24
- Deaths reported
- 0
- Injuries reported
- 23
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 24 adverse event reports that list this exact device (DI 00840420123862), received between Nov 22, 2022 and Feb 18, 2026 — classified as 23 injuries, 1 malfunction.
The most frequently reported specific device problem is “Osseointegration Problem” (6 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.
Reports received per month
Most reported problems
Device problems
- Adverse Event Without Identified Device or Use Problem14
- Osseointegration Problem6
- Migration3
- Detachment of Device or Device Component2
- Loss of Osseointegration2
- Appropriate Device Problem Term/Code Not Available1
- Device Difficult to Setup or Prepare1
- Insufficient Device Problem Information1
Patient problems
- Unspecified Infection9
- Inadequate Osseointegration8
- Implant Pain5
- Cyst(s)4
- Insufficient Information4
- Limb Fracture4
- Extraskeletal ossification2
- Failure of Implant2
Recent adverse event reports
The 24 most recent of 24 reports, in the reporter's own words as published by the FDA.
InjuryFeb 18, 2026Insufficient 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: Insufficient Information
MAUDE report 24381532 ↗InjuryNov 20, 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 MAY REQUIRE A REVISION SURGERY DUE TO PAIN.
Patient problems: Implant Pain
MAUDE report 20739548 ↗InjuryNov 20, 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 MAY REQUIRE A REVISION SURGERY DUE TO PAIN.
Patient problems: Implant Pain
MAUDE report 20738427 ↗InjuryJul 24, 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 DEVICE EXPLANT SURGERY DUE TO INFECTION. THE PATIENT RECEIVED A CEMENT SPACER.
Patient problems: Unspecified Infection
MAUDE report 19820210 ↗InjuryJul 24, 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 DEVICE EXPLANT SURGERY DUE TO INFECTION. THE PATIENT RECEIVED A CEMENT SPACER.
Patient problems: Unspecified Infection
MAUDE report 19818495 ↗InjuryApr 26, 2024Osseointegration Problem; Osseointegration Problem
THE DIGITAL STRYKER PROPHECY TEAM RECEIVED A CT SCAN INDICATING THAT THE PATIENT MAY REQUIRE A REVISION SURGERY DUE TO TIBIAL COMPONENT LOOSENING AND POLYETHYLENE DEBRIS. THE LEFT ANKLE WAS ASPIRATED TODAY THROUGH A ANTEROMEDIAL APPROACH AND FLUID WAS SENT FOR TOTAL CELL COUNT, GRAM STAIN, CULTURE AND SENSITIVITY.
Patient problems: Cyst(s); Inadequate Osseointegration
MAUDE report 19195532 ↗InjuryApr 12, 2024Loss of Osseointegration; Loss of Osseointegration
THE DIGITAL STRYKER PROPHECY TEAM RECEIVED A CT SCAN INDICATING THAT THE PATIENT MAY REQUIRE A REVISION SURGERY BECAUSE THE TIBIAL COMPONENT SINCE IT APPEARS LOOSE AND HAS MEDIAL MALLEOLAR CYST FORMATION. THE PHYSICIAN BROUGHT THE PATIENT TO SURGERY TO POSSIBLY REMOVE THE INBONE STEM AND TIBIAL TRAY AND TO REMOVE THE TALAR DOME. THE TIBIAL STEM AND TRAY WERE SOLID. THE PHYSICIAN USED THE INVISION DOME AND PLATE.
Patient problems: Cyst(s); Inadequate Osseointegration
MAUDE report 19101274 ↗InjuryApr 12, 2024Loss of Osseointegration; Loss of Osseointegration
THE DIGITAL STRYKER PROPHECY TEAM RECEIVED A CT SCAN INDICATING THAT THE PATIENT MAY REQUIRE A REVISION SURGERY BECAUSE THE TIBIAL COMPONENT SINCE IT APPEARS LOOSE AND HAS MEDIAL MALLEOLAR CYST FORMATION. THE PHYSICIAN BROUGHT THE PATIENT TO SURGERY TO POSSIBLY REMOVE THE INBONE STEM AND TIBIAL TRAY AND TO REMOVE THE TALAR DOME. THE TIBIAL STEM AND TRAY WERE SOLID. THE PHYSICIAN USED THE INVISION DOME AND PLATE.
Patient problems: Cyst(s); Inadequate Osseointegration
MAUDE report 19101272 ↗InjuryFeb 22, 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 18763441 ↗InjuryJan 30, 2024Osseointegration Problem; Migration; Osseointegration Problem; Migration
THE DIGITAL STRYKER PROPHECY TEAM RECEIVED A CT SCAN INDICATING THAT THE PATIENT MAY REQUIRE A REVISION SURGERY DUE TO MEDIAL MAL FRACTURE DUE TO POOR ALIGNMENT OF THE IMPLANT AND PATIENT'S CONTINUED WEIGHT BEARING ACTIVITIES.
Patient problems: Inadequate Osseointegration; Limb Fracture
MAUDE report 18608758 ↗MalfunctionDec 28, 2023Device Difficult to Setup or Prepare; Appropriate Device Problem Term/Code Not Available; Device Difficult to Setup or Prepare; Appropriate Device Problem Term/Code Not Available
DURING AN INBONE TOTAL ANKLE REPLACEMENT PROCEDURE, THE 18MM BASE STEM FAILED TO THREAD INTO THE OTHER IMPLANTS DUE TO IMPERFECTIONS IN ITS THREADS. DESPITE THIS SETBACK, THE SURGERY WAS SUCCESSFUL AS A BACKUP 18MM BASE WAS USED INSTEAD.
Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Insufficient Information
MAUDE report 18411255 ↗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 18322759 ↗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 17712465 ↗InjuryAug 31, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
THE DIGITAL STRYKER PROPHECY TEAM RECEIVED A REPORT INDICATING THE NEED FOR A REVISION DUE TO PAIN, RESULTING IN THE REMOVAL OF ALL PRIMARY TAA IMPLANTS AND THE PLACEMENT OF A CEMENT SPACER.
Patient problems: Implant Pain
MAUDE report 17660320 ↗InjuryAug 31, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
THE DIGITAL STRYKER PROPHECY TEAM RECEIVED A REPORT INDICATING THE NEED FOR A REVISION DUE TO PAIN, RESULTING IN THE REMOVAL OF ALL PRIMARY TAA IMPLANTS AND THE PLACEMENT OF A CEMENT SPACER.
Patient problems: Implant Pain
MAUDE report 17660318 ↗InjuryApr 5, 2023Osseointegration Problem; Migration; Osseointegration Problem; Migration
IT WAS REPORTED THAT THE PATIENT UNDERWENT A TOTAL ANKLE REPLACEMENT. ALLEGEDLY, THERE WAS POSTERIOR SUBSIDENCE OF THE TIBIAL IMPLANT. THE PATIENT WILL CONTINUE TO BE MONITORED AND NO FURTHER INTERVENTION WILL BE PERFORMED.
Patient problems: Inadequate Osseointegration; Insufficient Information; Limb Fracture
MAUDE report 16682699 ↗InjuryApr 5, 2023Osseointegration Problem; Migration; Osseointegration Problem; Migration
IT WAS REPORTED THAT THE PATIENT UNDERWENT A TOTAL ANKLE REPLACEMENT. ALLEGEDLY, THERE WAS POSTERIOR SUBSIDENCE OF THE TIBIAL IMPLANT. THE PATIENT WILL CONTINUE TO BE MONITORED AND NO FURTHER INTERVENTION WILL BE PERFORMED.
Patient problems: Inadequate Osseointegration; Insufficient Information; Limb Fracture
MAUDE report 16682689 ↗InjuryMar 28, 2023Adverse Event Without Identified Device or Use Problem; Osseointegration Problem; Adverse Event Without Identified Device or Use Problem; Osseointegration Problem
IT WAS REPORTED THAT THE PATIENT UNDERWENT A TOTAL ANKLE REPLACEMENT. ALLEGEDLY, THE PATIENT UNDERWENT AN EXPLANT SURGERY DUE TO INFECTION. THE PATIENT CURRENTLY HAS A BONE CEMENT SPACER.
Patient problems: Inadequate Osseointegration; Unspecified Infection
MAUDE report 16627041 ↗InjuryJan 23, 2023Adverse 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. THE PATIENT PRESENTED WITH INFECTION BASED ON WOUND ANTERIOR OF TIBIA AT THE INCISION SITE. THE IMPLANT WAS REMOVED AND ANTIBIOTIC CEMENT SPACER WAS INSERTED ANTIBIOTIC COURSE PRESCRIBED BY THE SURGEON. IT WAS NOTED THAT THERE WAS REMARKABLE PATIENT CIRCUMSTANCES/NON-COMPLIANCE.
Patient problems: Post Operative Wound Infection
MAUDE report 16225035 ↗InjuryJan 23, 2023Adverse 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. THE PATIENT PRESENTED WITH INFECTION BASED ON WOUND ANTERIOR OF TIBIA AT THE INCISION SITE. THE IMPLANT WAS REMOVED AND ANTIBIOTIC CEMENT SPACER WAS INSERTED ANTIBIOTIC COURSE PRESCRIBED BY THE SURGEON. IT WAS NOTED THAT THERE WAS REMARKABLE PATIENT CIRCUMSTANCES/NON-COMPLIANCE.
Patient problems: Post Operative Wound Infection
MAUDE report 16224986 ↗InjuryJan 9, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT THE PATIENT PRESENTED WITH AN UNKNOWN INFECTION. THE PATIENT UNDERWENT A TOTAL ANKLE SYSTEM REMOVAL PROCEDURE. THE INFECTION IS STILL ACTIVE.
Patient problems: Unspecified Infection
MAUDE report 16127305 ↗InjuryJan 9, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT THE PATIENT PRESENTED WITH AN UNKNOWN INFECTION. THE PATIENT UNDERWENT A TOTAL ANKLE SYSTEM REMOVAL PROCEDURE. THE INFECTION IS STILL ACTIVE.
Patient problems: Unspecified Infection
MAUDE report 16127139 ↗InjuryNov 22, 2022Detachment of Device or Device Component; Detachment of Device or Device Component
IT WAS REPORTED THAT THE PHYSICIAN BELIEVED THAT HE DIDN¿T ENGAGE THE TIBIAL STEM TO THE TIBIAL TRAY CORRECTLY. THE TIBIAL TRAY CAME AWAY FROM THE STEM. IT WAS NOTED THAT INFECTION OCCURRED AROUND THE STEM. THE SURGEON EXPLANTED ALL THE COMPONENTS. THE PATIENT IS HEALING IN PREPARATION FOR FUSION.
Patient problems: Extraskeletal ossification; Failure of Implant; Unspecified Infection
MAUDE report 15844302 ↗InjuryNov 22, 2022Detachment of Device or Device Component; Detachment of Device or Device Component
IT WAS REPORTED THAT THE PHYSICIAN BELIEVED THAT HE DIDN¿T ENGAGE THE TIBIAL STEM TO THE TIBIAL TRAY CORRECTLY. THE TIBIAL TRAY CAME AWAY FROM THE STEM. IT WAS NOTED THAT INFECTION OCCURRED AROUND THE STEM. THE SURGEON EXPLANTED ALL THE COMPONENTS. THE PATIENT IS HEALING IN PREPARATION FOR FUSION.
Patient problems: Extraskeletal ossification; Failure of Implant; Unspecified Infection
MAUDE report 15843584 ↗
Other PROSTHESIS, ANKLE, SEMI-CONSTRAINED, CEMENTED, METAL/POLYMER devices
- Vantage 350-22-03Exactech, Inc. · Prosthesis, Ankle, Semi-Constrained, Cemented, Metal/Polymer2 recalls2 reports
- Vantage 350-21-04Exactech, Inc. · Prosthesis, Ankle, Semi-Constrained, Cemented, Metal/Polymer2 recalls0 reports
- INFINITY 33630023Wright Medical Technology, Inc. · PROSTHESIS, ANKLE, SEMI-CONSTRAINED, CEMENTED, METAL/POLYMER60 reports
- INFINITY 33600020Wright Medical Technology, Inc. · PROSTHESIS, ANKLE, SEMI-CONSTRAINED, CEMENTED, METAL/POLYMER1 recall9 reports
- INFINITY 33650003Wright Medical Technology, Inc. · PROSTHESIS, ANKLE, SEMI-CONSTRAINED, CEMENTED, METAL/POLYMER55 reports
- Vantage 350-22-02Exactech, Inc. · Prosthesis, Ankle, Semi-Constrained, Cemented, Metal/Polymer1 recall5 reports
- INFINITY 33630022Wright Medical Technology, Inc. · PROSTHESIS, ANKLE, SEMI-CONSTRAINED, CEMENTED, METAL/POLYMER54 reports
- Vantage 350-21-02Exactech, Inc. · Prosthesis, Ankle, Semi-Constrained, Cemented, Metal/Polymer1 recall4 reports
Sources and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 13, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 13, 2026
- Page last rebuilt: Oct 13, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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