INBONE 220220903Recalls & reported problems

Summary

The FDA's MAUDE database contains 26 adverse event reports that list this exact device (DI 00840420124227), received between May 11, 2022 and Mar 9, 2026 — classified as 26 injuries.

The most frequently reported specific device problem is “Osseointegration Problem” (12 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 25 most recent of 26 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  THE MANUFACTURER RECEIVED A REPORT FROM THE NATIONAL JOINT REGISTRY THAT CONTAINS UNPUBLISHED COLLECTED DATA ON THE USAGE AND THE OUTCOMES OF THE ANKLE JOINT REPLACEMENT.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 24544117 ↗
• InjuryFeb 19, 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 24390630 ↗
• InjuryJan 6, 2026Osseointegration Problem

  THE DIGITAL STRYKER PROPHECY TEAM RECEIVED A CT SCAN INDICATING THAT THE PATIENT MAY REQUIRE A REVISION SURGERY DUE TO WORSENING PAIN AFTER BEING MONITORED FOR CYSTIC CHANGES FOR OVER 1 YEAR. THE LOOSENING OF THE IMPLANTS HAS PROGRESSED.

  Patient problems: Cyst(s); Inadequate Osseointegration; Pain

  MAUDE report 23973746 ↗
• InjuryNov 19, 2025Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED BY THE CUSTOMER THAT THE PATIENT REQUIRED A REVISION SURGERY BECAUSE OF A STAGED REVISION APPROACH, REQUIRING THE IMPLANTING A CEMENT SPACER DUE TO PERITIBIAL CYSTIC LOOSENING WITH INFECTION. THE TIBIAL COMPONENT DEMONSTRATED LOOSENING. WITH THE TALAR COMPONENTS THE MORSE TAPER BETWEEN THE TALAR DOME AND THE TALAR STEM HAD NOT BEEN PROPERLY ENGAGED AND INSPECTION AFTER REMOVAL OF THE TALAR STEM REVEALED DELAMINATION OF THE PLASMA COATING.

  Patient problems: Inadequate Osseointegration; Medical device site infection

  MAUDE report 23596205 ↗
• InjuryNov 12, 2025Osseointegration Problem; Osseointegration Problem

  THE DIGITAL STRYKER PROPHECY TEAM RECEIVED A CT SCAN INDICATING THAT THE PATIENT MAY REQUIRE A REVISION SURGERY. THE PRIMARY IMPLANT CONSISTED OF A TIBIAL TRAY AND TALAR DOME. THE PATIENT LATER REQUIRED REMOVAL OF THE IMPLANT AND PLACEMENT OF AN ANTIBIOTIC CEMENT SPACER DUE TO SUSPECTED INFECTION, ALONG WITH NOTED POOR BONE QUALITY AND A LARGE BONE CYST SUPERIOR TO THE TIBIAL TRAY.

  Patient problems: Arthritis; Cyst(s); Inadequate Osseointegration; Post Operative Wound Infection

  MAUDE report 23538739 ↗
• InjuryNov 11, 2025Adverse 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 ONGOING PAIN WITH WEIGHT BEARING AND THERE IS SOME OSTEOLYSIS BONE CYSTS UNDER THE TALAR COMPONENT.

  Patient problems: Cyst(s); Inadequate Osseointegration; Osteolysis; Pain

  MAUDE report 23525695 ↗
• 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 23095040 ↗
• InjuryMay 27, 2025Osseointegration Problem; Implant subsidence; Osseointegration Problem; Implant subsidence

  THE DIGITAL STRYKER PROPHECY TEAM RECEIVED A CT SCAN INDICATING THAT THE PATIENT MAY REQUIRE A REVISION SURGERY DUE TO SUBSIDENCE OF THE TALAR IMPLANT.

  Patient problems: Inadequate Osseointegration

  MAUDE report 22091850 ↗
• InjuryApr 29, 2025Adverse 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 OF BOTH THE TIBIAL AND TALAR COMPONENTS FOR REASONS OF INFECTION.

  Patient problems: Medical device site infection

  MAUDE report 21927781 ↗
• InjuryApr 23, 2025Osseointegration Problem; Osseointegration 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 UNTIL (B)(6) 2025. DURING THE REVIEW OF THE REPORT, IT WAS IDENTIFIED THAT ON (B)(6) 2025 A PATIENT REQUIRED REVISION SURGERY DUE TO ASEPTIC LOOSENING OF TIBIAL COMPONENT, COMPONENT MIGRATION/DISSOCIATION AND PERIPROSTHETIC FRACTURE, WHICH WAS NOT PREVIOUSLY REPORTED TO THE MANUFACTURER.

  Patient problems: Bone Fracture(s); Inadequate Osseointegration

  MAUDE report 21888317 ↗
• InjuryJan 27, 2025Adverse 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 OF BOTH THE TIBIAL, TALAR COMPONENTS AND POLY INSERT DUE TO INFECTION.

  Patient problems: Unspecified Infection

  MAUDE report 21248812 ↗
• InjuryDec 5, 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 JANUARY 2018 ¿ DECEMBER 2023. DURING THE REVIEW OF THE REPORT, IT WAS IDENTIFIED THAT ON (B)(6) 2021 A PATIENT REQUIRED REVISION SURGERY DUE TO UNEXPLAINED PAIN, STIFFNESS WHICH WAS NOT PREVIOUSLY REPORTED TO THE MANUFACTURER.

  Patient problems: Implant Pain; Loss of Range of Motion

  MAUDE report 20850916 ↗
• InjuryJun 14, 2024Osseointegration Problem; Osseointegration Problem

  THE DIGITAL STRYKER PROPHECY TEAM RECEIVED A CT SCAN INDICATING THAT THE PATIENT IS EXPERIENCING PAIN AND MAY REQUIRE A REVISION SURGERY DUE TO LOOSE TALAR COMPONENTS.

  Patient problems: Cyst(s); Implant Pain; Inadequate Osseointegration

  MAUDE report 19536532 ↗
• InjuryFeb 26, 2024Osseointegration Problem; Osseointegration Problem

  IT WAS REPORTED THAT THE PATIENT UNDERWENT A DEVICE EXPLANT SURGERY DUE TO TALUS LOSS OF BONE. THE PATIENT RECEIVED A CEMENT SPACER.

  Patient problems: Inadequate Osseointegration

  MAUDE report 18779365 ↗
• InjuryDec 18, 2023Osseointegration Problem; Osseointegration Problem

  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. THE PHYSICIAN NOTED THAT THE TIBIAL COMPONENT HAS SUBSIDED. THE PATIENT HAS CONTINUED PAIN AND LIMITED RANGE OF MOTION.

  Patient problems: Cyst(s); Implant Pain; Inadequate Osseointegration; Loss of Range of Motion

  MAUDE report 18347810 ↗
• InjuryJun 16, 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 FOR SUBSIDENCE IN BOTH TIBIA AND TALAR COMPONENT. PATIENT ANKLE PROGRESSIVELY DEFORMING INTO VALGUS. GIVEN THE STJ FUSION, THE TALAR/CALC BLOCK IS EVERTING AT THE ANKLE JOINT. THE PHYSICIAN IS ALSO PLANNING ON STABILIZING MEDIAL ANKLE WITH SOME SORT OF DELTOID REPAIR/AUGMENTATION.

  Patient problems: Deformity/ Disfigurement; Inadequate Osseointegration

  MAUDE report 17146434 ↗
• InjuryJun 8, 2023Osseointegration Problem; Osseointegration Problem

  THERE IS A REPORTED UPCOMING REVISION SURGERY. THE SURGERY INTENDED TO REVISE BOTH THE TALUS AND TIBIA SINCE THE SURGEON WAS NOT ABLE TO GET TO THE TIBIA FOR INTRAMEDULLARY PREPARATION AND FIXATION WITHOUT REMOVING THE TALUS. THE SURGEON WILL NEED TO USE INVISION TIBIA AND TALUS. THE REASON FOR THE REVISION IS BECAUSE THE TIBIA HAS SUBSIDED LIKELY SECONDARY TO OSTEOLYSIS UNDER COMPONENT AND LOW PROFILE TIBIA COMPONENT IN PATIENT WITH TN ARTHRODESIS.

  Patient problems: Inadequate Osseointegration; Osteolysis

  MAUDE report 17085985 ↗
• InjuryMay 9, 2023Osseointegration Problem; Osseointegration Problem

  IT WAS REPORTED THAT THE PATIENT UNDERWENT A TOTAL ANKLE REPLACEMENT. ALLEGEDLY, THERE WAS POSTERIOR SUBSIDENCE OF THE TIBIAL IMPLANT. THE PATIENT WILL CONTINUE TO BE MONITORED AND NO FURTHER INTERVENTION WILL BE PERFORMED. UPON FURTHER INVESTIGATION OF THE CT SCANS BY HEALTHCARE PROFESSIONALS IT WAS NOTED THAT "THERE IS A CLEAR RADIOLUCENCE AROUND THE TIBIAL COMPONENTS SUGGESTING LOOSENING. THE PE CANNOT BE ASSESSED DIRECTLY, HOWEVER, THERE IS NO SIGN OF LOOSENING OR BREAKAGE OF THE IMPLANT VISIBLE. THE TALAR COMPONENT SHOWS RADIOLUCENCE, SOME CYSTS AND POSTERIORLY FRACTURE LINE IS VISIBLE. LOOSENING AND A PERIPROSTHETIC FRACTURE CAN BE ASSUMED."

  Patient problems: Bone Fracture(s); Cyst(s); Inadequate Osseointegration; Limb Fracture

  MAUDE report 16899027 ↗
• 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 16627139 ↗
• 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 16224988 ↗
• InjuryJan 17, 2023Migration; Migration

  IT WAS REPORTED THAT THE PATIENT UNDERWENT A TOTAL ANKLE REPLACEMENT. THE PATIENT PRESENTED WITH PAIN. UPON CT SCAN, IT WAS NOTED THAT THE TALAR COMPONENT APPEARS TO HAVE SUBSIDED. THE PATIENT MAY NEED TO UNDERGO A REVISION SURGERY FOR THE TALAR COMPONENT AND POLY EXTRACTION.

  Patient problems: Bone Fracture(s); Cyst(s); Implant Pain

  MAUDE report 16188753 ↗
• 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 16126361 ↗
• InjuryNov 22, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  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; Unspecified Infection

  MAUDE report 15843470 ↗
• InjurySep 24, 2022Adverse 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. ALLEGEDLY, THE PATIENT MAY NEED TO UNDERGO A REVISION SURGERY FOR REASONS THAT ARE NOT AVAILABLE AT THE TIME OF THIS REPORT.

  Patient problems: Cyst(s); Insufficient Information

  MAUDE report 15480597 ↗
• InjuryJun 9, 2022Loss of Osseointegration; Loss of Osseointegration

  IT WAS REPORTED THAT THE IMPLANT IS LOOSE AND THE PATIENT WILL UNDERGO A REVISION SURGERY.

  Patient problems: Failure of Implant; Insufficient Information

  MAUDE report 14649916 ↗