INBONE 200222904Recalls & 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
- 7
- Deaths reported
- 0
- Injuries reported
- 7
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 7 adverse event reports that list this exact device (DI 00840420124104), received between Nov 22, 2022 and Mar 9, 2026 — classified as 7 injuries.
The most frequently reported specific device problem is “Malposition of Device” (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 Problem3
- Malposition of Device2
- Migration2
- Osseointegration Problem2
- Detachment of Device or Device Component1
- Implant subsidence1
Patient problems
- Limb Fracture3
- Inadequate Osseointegration2
- Unspecified Infection2
- Extraskeletal ossification1
- Failure of Implant1
- Implant Pain1
- Muscle/Tendon Damage1
- Pain1
Recent adverse event reports
The 7 most recent of 7 reports, in the reporter's own words as published by the FDA.
InjuryMar 9, 2026Adverse 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THE MANUFACTURER RECEIVED A REPORT FROM THE NATIONAL JOINT REGISTRY THAT CONTAINS UNPUBLISHED COLLECTED DATA ON THE USAGE AND THE OUTCOMES OF THE ANKLE JOINT REPLACEMENT.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 FOR THE MONTHLY REPORT OF (B)(6) 2026. DURING THE REVIEW OF THE REPORT, IT WAS IDENTIFIED THAT A PATIENT REQUIRED REVISION SURGERY DUE TO MALALIGNMENT WHICH WAS NOT PREVIOUSLY REPORTED TO THE MANUFACTURER.
Patient problems: Subluxation
MAUDE report 24544223 ↗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 23771838 ↗InjurySep 19, 2025Malposition of Device; Malposition of Device
THE DIGITAL STRYKER PROPHECY TEAM RECEIVED A CT SCAN INDICATING THAT THE PATIENT MAY REQUIRE A REVISION SURGERY DUE TO MALPOSITION AND CMT.
Patient problems: Muscle/Tendon Damage
MAUDE report 23094741 ↗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 20738575 ↗InjuryFeb 15, 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 REVISION PROCEDURE DUE TO A PERI PROSTHETIC FRACTURE.
Patient problems: Limb Fracture; Unspecified Infection
MAUDE report 18716201 ↗InjuryNov 30, 2023Malposition of Device; Osseointegration Problem; Migration; Malposition of Device; 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 18242148 ↗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: Failure of Implant; Unspecified Infection
MAUDE report 15843454 ↗
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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