INBONE 200011902Recalls & reported problems
Wright Medical Technology, Inc. · Class 2 · Implant
All models of INBONE (56)
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 13
- Deaths reported
- 0
- Injuries reported
- 13
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 13 adverse event reports that list this exact device (DI 00840420123909), received between Nov 22, 2022 and Feb 18, 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.
Reports received per month
Most reported problems
Device problems
- Adverse Event Without Identified Device or Use Problem8
- Osseointegration Problem4
- Insufficient Device Problem Information2
- Detachment of Device or Device Component1
- Migration1
Patient problems
- Unspecified Infection6
- Inadequate Osseointegration4
- Cyst(s)2
- Implant Pain2
- Insufficient Information2
- Limb Fracture2
- Extraskeletal ossification1
- Failure of Implant1
Recent adverse event reports
The 13 most recent of 13 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 24381340 ↗InjuryNov 10, 2025Insufficient Device Problem Information; Insufficient Device Problem Information
THE DIGITAL STRYKER PROPHECY TEAM RECEIVED A CT SCAN INDICATING THAT THE PATIENT MAY REQUIRE A REVISION SURGERY FOR REASONS UNKNOWN.
Patient problems: Insufficient Information
MAUDE report 23518684 ↗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 20738408 ↗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 19820206 ↗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 19195728 ↗InjuryFeb 23, 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 18767002 ↗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 18608759 ↗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 18322869 ↗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 17712466 ↗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 16627039 ↗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 16225001 ↗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 16126871 ↗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 15843571 ↗
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
- Vantage 350-22-02Exactech, Inc. · Prosthesis, Ankle, Semi-Constrained, Cemented, Metal/Polymer1 recall5 reports
- INFINITY 33650003Wright Medical Technology, Inc. · PROSTHESIS, ANKLE, SEMI-CONSTRAINED, CEMENTED, METAL/POLYMER55 reports
- INFINITY 33630022Wright Medical Technology, Inc. · PROSTHESIS, ANKLE, SEMI-CONSTRAINED, CEMENTED, METAL/POLYMER54 reports
- INFINITY 33600030Wright Medical Technology, 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 14, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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