INBONE 200347901Recalls & reported problems

Summary

The FDA's MAUDE database contains 46 adverse event reports that list this exact device (DI 00889797030830), received between May 5, 2022 and Feb 21, 2026 — classified as 45 injuries, 1 malfunction.

The most frequently reported specific device problem is “Osseointegration Problem” (18 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

Recent adverse event reports

The 25 most recent of 46 reports, in the reporter's own words as published by the FDA.

• InjuryFeb 21, 2026Insufficient Device Problem Information

  THE DIGITAL STRYKER PROPHECY TEAM RECEIVED A CT SCAN INDICATING THAT THE PATIENT MAY REQUIRE A REVISION SURGERY OF THE TALAR COMPONENTS FOR REASONS THAT ARE NOT AVAILABLE AT THE TIME OF THIS REPORT.

  Patient problems: Insufficient Information

  MAUDE report 24410324 ↗
• 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 24390638 ↗
• InjuryFeb 9, 2026Osseointegration Problem

  THE DIGITAL STRYKER PROPHECY TEAM RECEIVED A CT SCAN INDICATING THAT THE PATIENT MAY REQUIRE A REVISION SURGERY DUE TO ASEPTIC LOOSENING OF INBONE TALUS COMPONENT. THE INFINITY TIBIA IS WELL FIXED. I NEED TO REVISE TO AN INVISION TALUS FOR SCREW OPTIONS IN PLATE SO MY UNDERSTANDING IS I WILL NEED TO REMOVE THE WELL FIXED INFINITY TIBIAL COMPONENT AS THE POLY WON'T MATCH THE INVISION TALUS.

  Patient problems: Inadequate Osseointegration

  MAUDE report 24299341 ↗
• 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 23973744 ↗
• InjuryNov 24, 2025Loss 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 DUE TO "ASEPTIC LOOSENING. FOLLOWING IMPLANTATION, LUCENCY RAPIDLY DEVELOPED UNDER THE TALAR IMPLANT. LUCENCY ABOUT THE TIBIAL IMPLANT APPEARED LATER. I SUSPECT THAT NEITHER IMPLANT WAS EVER INGROWN. BOTH TALAR AND TIBIAL COMPONENTS NEED TO BE REVISED. THE TALUS IS A LITTLE THIN AND THE EXISTING CENTRAL PEG ABUTS THE SUBCHONDRAL BONE OF THE SUBTALAR JOINT POSTERIOR FACET."

  Patient problems: Inadequate Osseointegration

  MAUDE report 23632764 ↗
• InjuryNov 24, 2025Loss 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 DUE TO "ASEPTIC LOOSENING. FOLLOWING IMPLANTATION, LUCENCY RAPIDLY DEVELOPED UNDER THE TALAR IMPLANT. LUCENCY ABOUT THE TIBIAL IMPLANT APPEARED LATER. I SUSPECT THAT NEITHER IMPLANT WAS EVER INGROWN. BOTH TALAR AND TIBIAL COMPONENTS NEED TO BE REVISED. THE TALUS IS A LITTLE THIN AND THE EXISTING CENTRAL PEG ABUTS THE SUBCHONDRAL BONE OF THE SUBTALAR JOINT POSTERIOR FACET."

  Patient problems: Inadequate Osseointegration

  MAUDE report 23632756 ↗
• 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 23596207 ↗
• 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 23525662 ↗
• InjuryNov 11, 2025Insufficient Device Problem Information; Insufficient Device Problem Information

  THE DIGITAL STRYKER PROPHECY TEAM RECEIVED A CT SCAN INDICATING THAT THE PATIENT MAY REQUIRE A REVISION SURGERY FOR REASONS CURRENTLY UNKNOWN.

  Patient problems: Insufficient Information

  MAUDE report 23524850 ↗
• InjuryNov 5, 2025Insufficient Device Problem Information; Insufficient Device Problem Information

  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 23479530 ↗
• InjurySep 15, 2025Osseointegration Problem; Osseointegration 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 DUE TO POSSIBLE LOOSENING.

  Patient problems: Cyst(s); Inadequate Osseointegration

  MAUDE report 23057108 ↗
• MalfunctionMay 15, 2025Material Erosion; Material Erosion

  IT WAS REPORTED BY THE CUSTOMER THAT "WHEN DR. (B)(6) WAS IMPLANTING 200347901 (10MM TALAR STEM), SHE NOTICED THAT METAL WAS COMING OFF OF THE STEM AND INTO THE PATIENT'S BONE BEFORE IMPACTING". THERE WAS A 10-MINUTE DELAY WHILE A NEW IMPLANT WAS OPENED AND ASSEMBLED. THE CASE WAS COMPLETED SUCCESSFULLY. ONCE THE STEM INSIDE THE ANKLE, THERE WAS A METAL RESIDUE THAT WAS LEFT INSIDE THE ANKLE IMMEDIATELY.

  Patient problems: Foreign Body In Patient

  MAUDE report 22028600 ↗
• 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 21927938 ↗
• InjuryMar 26, 2025Insufficient Device Problem Information; Insufficient Device Problem Information

  THE DIGITAL STRYKER PROPHECY TEAM RECEIVED A CT SCAN INDICATING THAT THE PATIENT WAS EXPERIENCING PAIN AND MAY REQUIRE A REVISION SURGERY FOR REASONS THAT ARE NOT AVAILABLE AT THE TIME OF THIS REPORT.

  Patient problems: Implant Pain; Pain

  MAUDE report 21701855 ↗
• InjuryFeb 18, 2025Biocompatibility; Biocompatibility

  THE PATIENT REPORTED EXPERIENCING A SEVERE ALLERGIC REACTION AND INFECTION RELATED TO THE METAL COMPONENTS IN A STRYKER PRODUCT. THEY ALSO ALLEGE CHRONIC FOOT PAIN CAUSED BY THE IMPLANTS AND HAVE REQUESTED AN ANKLE AMPUTATION, STATING THEY DO NOT BELIEVE THEY ARE A SUITABLE CANDIDATE FOR AN ANKLE PROSTHESIS. POSTOPERATIVELY, THE PATIENT¿S PRIMARY CARE PHYSICIAN EXAMINED THE ANKLE AND NOTED SIGNS CONSISTENT WITH INFECTION. THE PATIENT WAS SUBSEQUENTLY PRESCRIBED ANTIBIOTICS. DURING A FOLLOW-UP WITH THE SURGEON, THEY WERE ADVISED TO USE NUMBER TWO COMPRESSION SOCKS. THE PATIENT IS CURRENTLY SEEKING ADDITIONAL MEDICAL OPINIONS REGARDING NEXT STEPS AND HAS MENTIONED IDENTIFYING A SURGEON WHO MAY BE ABLE TO PERFORM THE ANKLE AMPUTATION.

  Patient problems: Ambulation or Postural Difficulties; Discomfort; Fever; Implant Pain; Unspecified Infection; Wound Dehiscence; Wound Odor

  MAUDE report 21399962 ↗
• InjuryFeb 18, 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 DUE TO INFECTION.

  Patient problems: Unspecified Infection

  MAUDE report 21392541 ↗
• 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 21248810 ↗
• InjuryOct 28, 2024Osseointegration Problem; Unintended Movement; Osseointegration Problem; Unintended Movement

  THE DIGITAL STRYKER PROPHECY TEAM RECEIVED A CT SCAN INDICATING THAT THE PATIENT WILL UNDERGO A REVISION SURGERY DUE TO SEVERE LATERAL GUTTER IMPINGEMENT AS WELL AS THE ANTERIOR POSITIONING OF THE TALAR COMPONENT.

  Patient problems: Inadequate Osseointegration; Pain

  MAUDE report 20546249 ↗
• InjuryJul 10, 2024Osseointegration Problem; Insufficient Device Problem Information; Migration; Osseointegration Problem; Insufficient Device Problem Information; Migration

  THE DIGITAL STRYKER PROPHECY TEAM RECEIVED A CT SCAN INDICATING THAT THE PATIENT MAY REQUIRE A REVISION SURGERY OF THE TALAR COMPONENT BECAUSE THE TALAR COLLAPSED. IT WAS DUE TO THE SCREW REMOVE HOLE AND A CYST IN THE ORIGINAL SURGERY.

  Patient problems: Cyst(s); Inadequate Osseointegration; Insufficient Information

  MAUDE report 19715155 ↗
• InjuryJun 13, 2024Osseointegration Problem; Migration; Osseointegration Problem; Migration

  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 19533070 ↗
• InjuryMar 6, 2024Insufficient Device Problem Information; Insufficient Device Problem Information

  THE DIGITAL STRYKER PROPHECY TEAM RECEIVED A CT SCAN INDICATING THAT THE PATIENT MAY REQUIRE A REVISION SURGERY OF BOTH SIDES OF THE IMPLANT USING INVISION IMPLANTS. PATIENT HAD CONTINUED PAIN AND CT SCAN SUGGESTS SOME LOOSENING OF AT LEAST THE TIBIAL COMPONENT.

  Patient problems: Implant Pain

  MAUDE report 18852031 ↗
• 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 18803131 ↗
• 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 18783214 ↗
• 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 18716990 ↗
• 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 18322867 ↗