INBONE 220222905Recalls & 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
- 3
- Deaths reported
- 0
- Injuries reported
- 3
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00840420124296), received between Feb 26, 2024 and Dec 30, 2024 — classified as 3 injuries.
The most frequently reported specific device problem is “Osseointegration Problem” (2 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 Problem2
- Osseointegration Problem2
- Loss of Osseointegration1
Patient problems
- Cyst(s)2
- Inadequate Osseointegration2
- Implant Pain1
- Osteolysis1
- Unspecified Infection1
Recent adverse event reports
The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.
InjuryDec 30, 2024Adverse 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THE MANUFACTURER RECEIVED A REPORT FROM THE NATIONAL JOINT REGISTRY THAT CONTAINS UNPUBLISHED COLLECTED DATA ON THE USAGE AND THE OUTCOMES OF THE ANKLE JOINT REPLACEMENT.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 (B)(6) 2018 ¿ (B)(6) 2023. DURING THE REVIEW OF THE REPORT, IT WAS IDENTIFIED THAT ON (B)(6) 2022 A PATIENT REQUIRED REVISION SURGERY DUE TO INFECTION LYSIS OF TALUS, WHICH WAS NOT PREVIOUSLY REPORTED TO THE MANUFACTURER.
Patient problems: Osteolysis; Unspecified Infection
MAUDE report 21035786 ↗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 18800707 ↗InjuryFeb 26, 2024Loss 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 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 18783120 ↗
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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