INBONE 200010904Recalls & 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 00840420123886), received between Feb 14, 2022 and Mar 10, 2023 — classified as 3 injuries.
The most frequently reported specific device problem is “Migration” (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.
Most reported problems
Device problems
- Migration2
- Osseointegration Problem2
- Adverse Event Without Identified Device or Use Problem1
Patient problems
- Implant Pain2
- Inadequate Osseointegration2
- Bone Fracture(s)1
Recent adverse event reports
The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.
InjuryMar 10, 2023Osseointegration Problem; Migration; Osseointegration Problem; Migration
IT WAS REPORTED THAT THE PATIENT UNDERWENT A TOTAL ANKLE REPLACEMENT. ALLEGEDLY, THE PATIENT MAY NEED TO UNDERGO A REVISION SURGERY DUE TO PAIN AND LOOSENING OF THE TIBIA STEM OF THE PROSTHESIS. NO OPERATING HAS BEEN DONE. THE PATIENT HAS BEEN GOING THROUGH PHYSICAL THERAPY WITH NO POSITIVE RETURNS.
Patient problems: Implant Pain; Inadequate Osseointegration
MAUDE report 16522453 ↗InjuryMar 10, 2023Osseointegration Problem; Migration; Osseointegration Problem; Migration
IT WAS REPORTED THAT THE PATIENT UNDERWENT A TOTAL ANKLE REPLACEMENT. ALLEGEDLY, THE PATIENT MAY NEED TO UNDERGO A REVISION SURGERY DUE TO PAIN AND LOOSENING OF THE TIBIA STEM OF THE PROSTHESIS. NO OPERATING HAS BEEN DONE. THE PATIENT HAS BEEN GOING THROUGH PHYSICAL THERAPY WITH NO POSITIVE RETURNS.
Patient problems: Implant Pain; Inadequate Osseointegration
MAUDE report 16522442 ↗InjuryFeb 14, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT DURING A REVISION SURGERY THE PATIENT SUFFERED AN ANTERIOR MIDLINE FRACTURE OF THE TIBIA UPON IMPLANTATION OF THE TIBIAL STEMS. THE SURGEON USED A PLATE AND SCREWS TO TREAT THE FRACTURE. THE SURGEON EXPECTS THE PATIENT TO RECOVER WELL AND WILL PROCEED WITH NON-WEIGHT BEARING FOR 8 WEEKS.
Patient problems: Bone Fracture(s)
MAUDE report 13524943 ↗
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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