INBONE 200011901Recalls & reported problems

Summary

The FDA's MAUDE database contains 15 adverse event reports that list this exact device (DI 00840420123893), received between Dec 27, 2022 and May 28, 2026 — classified as 15 injuries.

The most frequently reported specific device problem is “Loss of Osseointegration” (3 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 15 most recent of 15 reports, in the reporter's own words as published by the FDA.

• InjuryMay 28, 2026Loss of Osseointegration

  THE STRYKER PROPHECY TEAM RECEIVED A CT SCAN FOR AN UPCOMING REVISION SURGERY. THE TALAR COMPONENT WAS INITIALLY IMPLANTED TOO FAR LATERAL AND WAS IMPINGING ON THE FIBULA. THE TALAR COMPONENT WAS REMOVED. UPON REMOVAL, THE SURGEON DISCOVERED THE TIBIAL COMPONENT WAS LOOSE, IT WAS REMOVED.

  Patient problems: Inadequate Osseointegration

  MAUDE report 25319078 ↗
• InjuryDec 23, 2025Adverse 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 FOR REASONS THAT ARE NOT AVAILABLE AT THE TIME OF THIS REPORT.

  Patient problems: Insufficient Information; Post Operative Wound Infection

  MAUDE report 23876694 ↗
• InjuryOct 22, 2025Osseointegration Problem; 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 23361336 ↗
• InjuryOct 15, 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 PAIN IN JOINTS.

  Patient problems: Cyst(s); Pain

  MAUDE report 23301392 ↗
• InjuryJun 24, 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 UNDERWENT A DEVICE EXPLANT SURGERY DUE TO INFECTION. THE PATIENT RECEIVED A CEMENT SPACER.

  Patient problems: Post Operative Wound Infection

  MAUDE report 22319175 ↗
• 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 21701439 ↗
• 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 21400562 ↗
• 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 19101285 ↗
• InjuryFeb 16, 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 CAUSED BY SEPTIC ARTHRITIS FROM THE SPINE THAT TRAVELED THROUGHOUT THE LOWER EXTREMITIES OF HER BODY. THE PATIENT RECEIVED A CEMENT SPACER. THE INFECTION WAS DISCOVERED DURING THE PURULENT DRAINAGE FROM THE LATERAL ASPECT OF THE ANKLE.

  Patient problems: Arthritis; Post Operative Wound Infection; Unspecified Infection

  MAUDE report 18727664 ↗
• InjuryFeb 16, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT WAS WALKING WITH A LIMP, HAS PAIN, SWELLING IN ANKLE AND IN UNABLE TO WALK. THE PATIENT TOLD THE DOCTOR AND WAS PROVIDED SUPPORT HOSE AND THOSE DIDN'T MAKE A DIFFERENCE. PATIENT REQUIRES A WHEELCHAIR AT TIMES TO MOVE AROUND.

  Patient problems: Ambulation or Postural Difficulties; Implant Pain; Swelling/ Edema

  MAUDE report 18721293 ↗
• InjuryNov 3, 2023Loss of Osseointegration; Adverse Event Without Identified Device or Use Problem; Loss of Osseointegration; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT HAD POST TRAUMATIC ARTHRITIS FROM A PRIOR PILON FRACTURE. THE DISTAL TIBIAL BONE WAS RATHER SOFT AT THE TIME OF SURGERY- THE TALAR COMPONENT COLLAPSED INTO SOME VALGUS. THE PATIENT HAD A TIBIAL PERIPROSTHETIC FRACTURE THAT REQUIRED SURGERY. THE PATIENT CONTINUES TO HAVE DISCOMFORT. THE PHYSICIAN IS PLANNING TO REVISE THE PATIENT WITH LONGER TIBIAL STEM FOR ADDED STABILITY. THE PHYSICIAN PLANS TO HAVE A NAIL BACK UP IN CASE THE BONE IS TOO SOFT AND UNABLE TO REVISE. DURING A LATER CONVERSATION THE PHYSICIAN REPORTED THAT THE IMPLANT COMPONENTS WERE NOT THE CAUSE OF THE FAILURE, IT WAS THE PATIENT'S POOR QUALITY OF BONE. THEY PLAN ON REVISING IN THE NEAR FUTURE BUT THE PATIENT IS CURRENTLY HAVING CARDIAC ISSUES AND HAS NOT BEEN CLEARED BY CARDIOLOGY.

  Patient problems: Bone Fracture(s); Discomfort; Inadequate Osseointegration

  MAUDE report 18070168 ↗
• InjurySep 18, 2023Osseointegration Problem; Migration; Osseointegration Problem; Migration

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

  Patient problems: Inadequate Osseointegration

  MAUDE report 17770289 ↗
• 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 17660105 ↗
• InjuryApr 5, 2023Osseointegration Problem; Migration; Osseointegration Problem; Migration

  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.

  Patient problems: Inadequate Osseointegration; Insufficient Information; Limb Fracture

  MAUDE report 16682694 ↗
• 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 16057832 ↗