INBONE 200010901Recalls & reported problems
Wright Medical Technology, Inc. · Class 2 · Implant
Quick summary
This Inbone ankle implant from Wright Medical is a metal-and-polymer replacement for a damaged ankle joint. The 28 reports mostly describe the implant not bonding to the bone, loosening or sinking, and infection, sometimes leading to revision surgery. There are 28 injuries and no deaths. 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
- 28
- Deaths reported
- 0
- Injuries reported
- 28
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 28 adverse event reports that list this exact device (DI 00840420123855), received between Feb 14, 2022 and May 28, 2026 — classified as 28 injuries.
The most frequently reported specific device problem is “Osseointegration Problem” (7 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 Problem19
- Osseointegration Problem7
- Loss of Osseointegration3
- Migration3
- Biocompatibility1
- Implant subsidence1
- Insufficient Device Problem Information1
Patient problems
- Unspecified Infection10
- Inadequate Osseointegration9
- Pain6
- Post Operative Wound Infection5
- Arthritis4
- Implant Pain4
- Ambulation or Postural Difficulties3
- Cyst(s)2
Recent adverse event reports
The 25 most recent of 28 reports, in the reporter's own words as published by the FDA.
InjuryMay 28, 2026Loss of Osseointegration; Adverse Event Without Identified Device or Use Problem
THE STRYKER PROPHECY TEAM RECEIVED A CT SCAN FOR AN UPCOMING REVISION SURGERY. THE TALAR COMPONENT WAS INITIALLY IMPLANTED TOO FAR LATERAL AND WAS IMPINGING ON THE FIBULA. THE TALAR COMPONENT WAS REMOVED. UPON REMOVAL, THE SURGEON DISCOVERED THE TIBIAL COMPONENT WAS LOOSE, IT WAS REMOVED.
Patient problems: Inadequate Osseointegration
MAUDE report 25319198 ↗InjuryMay 28, 2026Loss of Osseointegration; Adverse Event Without Identified Device or Use Problem
THE STRYKER PROPHECY TEAM RECEIVED A CT SCAN FOR AN UPCOMING REVISION SURGERY. THE TALAR COMPONENT WAS INITIALLY IMPLANTED TOO FAR LATERAL AND WAS IMPINGING ON THE FIBULA. THE TALAR COMPONENT WAS REMOVED. UPON REMOVAL, THE SURGEON DISCOVERED THE TIBIAL COMPONENT WAS LOOSE, IT WAS REMOVED.
Patient problems: Inadequate Osseointegration
MAUDE report 25319086 ↗InjuryMar 20, 2026Adverse 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. REVISION PERFORMED DUE TO A POSTOPERATIVE WOUND INFECTION.
Patient problems: Arthritis; Post Operative Wound Infection
MAUDE report 24654551 ↗InjuryMar 20, 2026Adverse 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. REVISION PERFORMED DUE TO A POSTOPERATIVE WOUND INFECTION.
Patient problems: Arthritis; Post Operative Wound Infection
MAUDE report 24654469 ↗InjuryFeb 3, 2026Adverse 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 AN INFECTION.
Patient problems: Unspecified Infection
MAUDE report 24248701 ↗InjuryFeb 3, 2026Adverse 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 AN INFECTION.
Patient problems: Unspecified Infection
MAUDE report 24248700 ↗InjuryDec 10, 2025Osseointegration Problem; Migration; Implant subsidence; Osseointegration Problem; Migration; Implant subsidence
THE DIGITAL STRYKER PROPHECY TEAM RECEIVED A CT SCAN INDICATING THAT THE PATIENT HAS MULTIPLE FRACTURES IN THE TIBIA AND MAY REQUIRE A REVISION SURGERY DUE TO SUBSIDENCE OF THE TIBIAL COMPONENT AND THE IMPLANT TILTING INTO VARUS, CAUSING SIGNIFICANT PAIN.
Patient problems: Extraskeletal ossification; Inadequate Osseointegration; Limb Fracture; Pain
MAUDE report 23771852 ↗InjuryNov 24, 2025Loss of Osseointegration; Osseointegration Problem; Loss of Osseointegration; Osseointegration Problem
THE DIGITAL STRYKER PROPHECY TEAM RECEIVED A CT SCAN INDICATING THAT THE PATIENT MAY REQUIRE A REVISION SURGERY DUE TO "ASEPTIC LOOSENING. FOLLOWING IMPLANTATION, LUCENCY RAPIDLY DEVELOPED UNDER THE TALAR IMPLANT. LUCENCY ABOUT THE TIBIAL IMPLANT APPEARED LATER. I SUSPECT THAT NEITHER IMPLANT WAS EVER INGROWN. BOTH TALAR AND TIBIAL COMPONENTS NEED TO BE REVISED. THE TALUS IS A LITTLE THIN AND THE EXISTING CENTRAL PEG ABUTS THE SUBCHONDRAL BONE OF THE SUBTALAR JOINT POSTERIOR FACET."
Patient problems: Inadequate Osseointegration
MAUDE report 23632950 ↗InjuryOct 22, 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. FOLLOWING IMPLANTATION, LUCENCY RAPIDLY DEVELOPED UNDER THE TALAR IMPLANT. LUCENCY ABOUT THE TIBIAL IMPLANT APPEARED LATER. I SUSPECT THAT NEITHER IMPLANT WAS EVER INGROWN. BOTH TALAR AND TIBIAL COMPONENTS NEED TO BE REVISED. THE TALUS IS A LITTLE THIN AND THE EXISTING CENTRAL PEG ABUTS THE SUBCHONDRAL BONE OF THE SUBTALAR JOINT POSTERIOR FACET."
Patient problems: Inadequate Osseointegration
MAUDE report 23361164 ↗InjuryOct 15, 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 PAIN IN JOINTS.
Patient problems: Cyst(s); Pain
MAUDE report 23301445 ↗InjuryOct 15, 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 PAIN IN JOINTS.
Patient problems: Cyst(s); Pain
MAUDE report 23301012 ↗InjuryJun 24, 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 UNDERWENT A DEVICE EXPLANT SURGERY DUE TO INFECTION. THE PATIENT RECEIVED A CEMENT SPACER.
Patient problems: Post Operative Wound Infection
MAUDE report 22319173 ↗InjuryMay 20, 2025Osseointegration Problem; Osseointegration Problem
THE DIGITAL STRYKER PROPHECY TEAM RECEIVED A CT SCAN INDICATING THAT THE PATIENT MAY REQUIRE A REVISION SURGERY DUE TO PAIN AND LOOSENING.
Patient problems: Inadequate Osseointegration; Pain
MAUDE report 22056649 ↗InjuryMay 20, 2025Osseointegration Problem; Osseointegration Problem
THE DIGITAL STRYKER PROPHECY TEAM RECEIVED A CT SCAN INDICATING THAT THE PATIENT MAY REQUIRE A REVISION SURGERY DUE TO PAIN AND LOOSENING.
Patient problems: Inadequate Osseointegration; Pain
MAUDE report 22056571 ↗InjuryMar 26, 2025Insufficient Device Problem Information; Insufficient Device Problem Information
THE DIGITAL STRYKER PROPHECY TEAM RECEIVED A CT SCAN INDICATING THAT THE PATIENT WAS EXPERIENCING PAIN AND MAY REQUIRE A REVISION SURGERY FOR REASONS THAT ARE NOT AVAILABLE AT THE TIME OF THIS REPORT.
Patient problems: Implant Pain; Pain
MAUDE report 21701433 ↗InjuryFeb 18, 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 INFECTION.
Patient problems: Unspecified Infection
MAUDE report 21398166 ↗InjuryFeb 18, 2025Biocompatibility; Biocompatibility
THE PATIENT REPORTED EXPERIENCING A SEVERE ALLERGIC REACTION AND INFECTION RELATED TO THE METAL COMPONENTS IN A STRYKER PRODUCT. THEY ALSO ALLEGE CHRONIC FOOT PAIN CAUSED BY THE IMPLANTS AND HAVE REQUESTED AN ANKLE AMPUTATION, STATING THEY DO NOT BELIEVE THEY ARE A SUITABLE CANDIDATE FOR AN ANKLE PROSTHESIS. POSTOPERATIVELY, THE PATIENT¿S PRIMARY CARE PHYSICIAN EXAMINED THE ANKLE AND NOTED SIGNS CONSISTENT WITH INFECTION. THE PATIENT WAS SUBSEQUENTLY PRESCRIBED ANTIBIOTICS. DURING A FOLLOW-UP WITH THE SURGEON, THEY WERE ADVISED TO USE NUMBER TWO COMPRESSION SOCKS. THE PATIENT IS CURRENTLY SEEKING ADDITIONAL MEDICAL OPINIONS REGARDING NEXT STEPS AND HAS MENTIONED IDENTIFYING A SURGEON WHO MAY BE ABLE TO PERFORM THE ANKLE AMPUTATION.
Patient problems: Ambulation or Postural Difficulties; Discomfort; Fever; Implant Pain; Unspecified Infection; Wound Dehiscence; Wound Odor
MAUDE report 21396147 ↗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 DEVICE EXPLANT SURGERY DUE TO INFECTION CAUSED BY SEPTIC ARTHRITIS FROM THE SPINE THAT TRAVELED THROUGHOUT THE LOWER EXTREMITIES OF HER BODY. THE PATIENT RECEIVED A CEMENT SPACER. THE INFECTION WAS DISCOVERED DURING THE PURULENT DRAINAGE FROM THE LATERAL ASPECT OF THE ANKLE.
Patient problems: Arthritis; Post Operative Wound Infection; Unspecified Infection
MAUDE report 18731490 ↗InjuryFeb 16, 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 CAUSED BY SEPTIC ARTHRITIS FROM THE SPINE THAT TRAVELED THROUGHOUT THE LOWER EXTREMITIES OF HER BODY. THE PATIENT RECEIVED A CEMENT SPACER. THE INFECTION WAS DISCOVERED DURING THE PURULENT DRAINAGE FROM THE LATERAL ASPECT OF THE ANKLE.
Patient problems: Arthritis; Post Operative Wound Infection; Unspecified Infection
MAUDE report 18727666 ↗InjuryFeb 16, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT THE PATIENT WAS WALKING WITH A LIMP, HAS PAIN, SWELLING IN ANKLE AND IN UNABLE TO WALK. THE PATIENT TOLD THE DOCTOR AND WAS PROVIDED SUPPORT HOSE AND THOSE DIDN'T MAKE A DIFFERENCE. PATIENT REQUIRES A WHEELCHAIR AT TIMES TO MOVE AROUND.
Patient problems: Ambulation or Postural Difficulties; Implant Pain; Swelling/ Edema
MAUDE report 18721297 ↗InjuryFeb 16, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT THE PATIENT WAS WALKING WITH A LIMP, HAS PAIN, SWELLING IN ANKLE AND IN UNABLE TO WALK. THE PATIENT TOLD THE DOCTOR AND WAS PROVIDED SUPPORT HOSE AND THOSE DIDN'T MAKE A DIFFERENCE. PATIENT REQUIRES A WHEELCHAIR AT TIMES TO MOVE AROUND.
Patient problems: Ambulation or Postural Difficulties; Implant Pain; Swelling/ Edema
MAUDE report 18721292 ↗InjurySep 19, 2023Osseointegration 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 LOOSENING OF THE TIBIA.
Patient problems: Inadequate Osseointegration
MAUDE report 17772848 ↗InjurySep 18, 2023Osseointegration 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 LOOSENING OF THE TIBIA.
Patient problems: Inadequate Osseointegration
MAUDE report 17770291 ↗InjuryAug 18, 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 HAD AN INFECTION, THE TOTAL ANKLE WAS EXPLANTED AND A CEMENT SPACER WAS INSERTED. THE PATIENT WAS WASHED OUT AND A POLY EXCHANGE WAS DONE ALONG WITH ANTIBIOTICS.
Patient problems: Unspecified Infection
MAUDE report 17575124 ↗InjuryAug 18, 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 HAD AN INFECTION, THE TOTAL ANKLE WAS EXPLANTED AND A CEMENT SPACER WAS INSERTED. THE PATIENT WAS WASHED OUT AND A POLY EXCHANGE WAS DONE ALONG WITH ANTIBIOTICS.
Patient problems: Unspecified Infection
MAUDE report 17575098 ↗
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: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.