INBONE 200009902Recalls & reported problems

Summary

The FDA's MAUDE database contains 22 adverse event reports that list this exact device (DI 00840420123848), received between Dec 30, 2021 and Feb 18, 2026 — classified as 18 injuries, 4 malfunctions.

The most frequently reported specific device problem is “Osseointegration Problem” (5 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.

Most reported problems

Recent adverse event reports

The 22 most recent of 22 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 24381552 ↗
• 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 23771736 ↗
• InjuryOct 22, 2024Adverse Event Without Identified Device or Use Problem; Insufficient Device Problem Information; Adverse Event Without Identified Device or Use Problem; Insufficient Device Problem Information

  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; Insufficient Information

  MAUDE report 20510697 ↗
• 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 19820389 ↗
• InjuryApr 12, 2024Loss of Osseointegration; Loss of Osseointegration

  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 19099900 ↗
• InjuryApr 2, 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; Limb Fracture

  MAUDE report 19017714 ↗
• 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 18767003 ↗
• 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 18716200 ↗
• MalfunctionDec 28, 2023Device Difficult to Setup or Prepare; Device Difficult to Setup or Prepare

  DURING AN INBONE TOTAL ANKLE REPLACEMENT PROCEDURE, THE 18MM BASE STEM FAILED TO THREAD INTO THE OTHER IMPLANTS DUE TO IMPERFECTIONS IN ITS THREADS. DESPITE THIS SETBACK, THE SURGERY WAS SUCCESSFUL AS A BACKUP 18MM BASE WAS USED INSTEAD. THE RETURNED PRODUCT WILL UNDERGO EXAMINATION TO IDENTIFY THE FLAW IN THE BASE STEM.

  Patient problems: Insufficient Information; No Clinical Signs, Symptoms or Conditions

  MAUDE report 18411248 ↗
• 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 18322870 ↗
• 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 18242137 ↗
• 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 17712461 ↗
• InjuryAug 31, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE DIGITAL STRYKER PROPHECY TEAM RECEIVED A REPORT INDICATING THE NEED FOR A REVISION DUE TO PAIN, RESULTING IN THE REMOVAL OF ALL PRIMARY TAA IMPLANTS AND THE PLACEMENT OF A CEMENT SPACER.

  Patient problems: Implant Pain

  MAUDE report 17660319 ↗
• 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 16627062 ↗
• 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 16224998 ↗
• 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 16127165 ↗
• InjuryDec 27, 2022Inadequacy of Device Shape and/or Size; Migration; Inadequacy of Device Shape and/or Size; Migration

  IT WAS REPORTED THAT THE PATIENT UNDERWENT A TOTAL ANKLE REPLACEMENT. THE PATIENT COMPLAINED OF PAIN. ALLEGEDLY, THE PATIENT MAY NEED TO UNDERGO A REVISION SURGERY FOR IMPLANT LOOSENING LIKELY CAUSED BY PATIENT ANATOMY.

  Patient problems: Failure of Implant; Implant Pain

  MAUDE report 16057831 ↗
• 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 15843562 ↗
• MalfunctionAug 19, 2022Off-Label Use; Defective Device; Off-Label Use; Defective Device

  IT WAS REPORTED THAT THE BASE STEM DID NOT HAVE THE PLASMA SPRAY COATING. THE SURGEON FELT COMFORTABLE ENOUGH TO USE THE IMPLANT IN THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15260350 ↗
• InjuryMar 15, 2022Appropriate Device Problem Term/Code Not Available; Loosening of Implant Not Related to Bone-Ingrowth; Appropriate Device Problem Term/Code Not Available; Loosening of Implant Not Related to Bone-Ingrowth

  IT WAS REPORTED THAT THE PATIENT UNDERWENT A LEFT ANKLE HARDWARE REMOVAL AND LEFT REVISION TOTAL ANKLE REPLACEMENT WITH POSSIBLE COLLATERAL LIGAMENT REPAIR WITH INTERNAL BRACE AND LEFT ACHILLES TENDON LENGTHENING ALL ON THE LEFT. THE PATIENT IS STATUS POST LEFT ANKLE REPLACEMENT 2019 BUT CONTINUES TO DEVELOP ARTHRITIS CHANGES PARTICULAR ALONG THE MEDIAL AND LATERAL GUTTER ALONG WITH PAIN AND REDUCED RANGE OF MOTION. THE PATIENT ALSO HAS SOME LOOSENING OF IMPLANT ON IMAGING. THE PATIENT ELECTED FOR REVISION REPLACEMENT WITH LARGER IMPLANT AND IS SCHEDULED FOR SURGERY (B)(6) 2021. THE REPORTS OVERALL HE IS DOING OK. HE REMAINS FOLLOWED WITH RHEUMATOLOGY FOR HIS RA WHICH HAS BEEN WELL CONTROLLED ON (B)(6).

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Implant Pain; Loss of Range of Motion; Rheumatoid Arthritis

  MAUDE report 13776079 ↗
• MalfunctionJan 12, 2022Nonstandard Device; Nonstandard Device

  IT WAS REPORTED THAT THE BASE PLATE HAS NO PLASMA SPRAY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13238602 ↗
• MalfunctionDec 30, 2021Nonstandard Device; Nonstandard Device

  IT WAS REPORTED THAT THE SURGEON OPENED THE IMPLANT INTO THE STERILE FIELD AND NOTED THAT IT DID NOT HAVE PLASMA SPRAY COATING ON IT. THE SURGEON DID NOT USE THE IMPLANT AND OPENED UP A BACKUP IMPLANT WHICH HAD THE PLASMA SPRAY COATING AND USED IT INSTEAD.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13118900 ↗