INBONE 220222903Recalls & reported problems

Summary

The FDA's MAUDE database contains 9 adverse event reports that list this exact device (DI 00840420124272), received between Jan 6, 2022 and May 28, 2026 — classified as 8 injuries, 1 malfunction.

The most frequently reported specific device problem is “Loss of Osseointegration” (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.

Most reported problems

Recent adverse event reports

The 9 most recent of 9 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 25319200 ↗
• InjuryMar 30, 2026Adverse 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 FOR REASONS THAT ARE NOT AVAILABLE AT THE TIME OF THIS REPORT. THE PATIENT RECEIVED A CEMENT SPACER.

  Patient problems: Insufficient Information

  MAUDE report 24735398 ↗
• InjuryOct 2, 2025Adverse 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  THE MANUFACTURER RECEIVED A REPORT FROM THE NATIONAL JOINT REGISTRY THAT CONTAINS UNPUBLISHED COLLECTED DATA ON THE USAGE AND THE OUTCOMES OF THE ANKLE JOINT REPLACEMENT.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 UNTIL (B)(6) 2024. DURING THE REVIEW OF THE REPORT, IT WAS IDENTIFIED THAT ON A PATIENT REQUIRED REVISION SURGERY DUE TO ACTIVE INFECTION, WHICH WAS NOT PREVIOUSLY REPORTED TO THE MANUFACTURER.

  Patient problems: Unspecified Infection

  MAUDE report 23199766 ↗
• InjuryMay 20, 2025Osseointegration Problem; Osseointegration Problem

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

  Patient problems: Inadequate Osseointegration; Pain

  MAUDE report 22056655 ↗
• 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 21701321 ↗
• InjuryApr 9, 2024Use of Device Problem; Adverse Event Without Identified Device or Use Problem; Use of Device Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED IT WAS REPORTED THAT TWO IMPLANTS WERE FOUND TO BE DEFECTIVE DURING A PRIMARY PROPHECY INBONE CASE. THE TIBIA FRACTURED AS A RESULT OF THE REPEATED IMPACT TO THE TIBIAL PLATE AND STEM. ARTHREX PLATES AND SCREWS WERE USED TO MANAGE THE FRACTURE AS WELL AS BONE CEMENT TO HELP FIXATE THE INBONE STEM. NEW IMPLANTS WERE USED TO COMPLETE THE CASE SUCCESSFULLY.

  Patient problems: Bone Fracture(s)

  MAUDE report 19071615 ↗
• 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 18069708 ↗
• InjuryAug 18, 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 HAD AN INFECTION, THE TOTAL ANKLE WAS EXPLANTED AND A CEMENT SPACER WAS INSERTED. THE PATIENT WAS WASHED OUT AND A POLY EXCHANGE WAS DONE ALONG WITH ANTIBIOTICS.

  Patient problems: Unspecified Infection

  MAUDE report 17575421 ↗
• MalfunctionJan 6, 2022Detachment of Device or Device Component; Detachment of Device or Device Component

  DURING A REVISION TAR INTERVENTION THERE WAS A DISASSOCIATION BETWEEN THE TIBIAL TRAY AND THE BASE STEM PIECE WHILE TRIALING FOR THE PE INSERT THICKNESS. SURGICAL TECHNIQUE WAS FOLLOWED AS DESCRIBED, MORSE TAPER LOCKING BETWEEN THE 2 COMPONENTS WAS TESTED AS DESCRIBED IN TECHNIQUE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13181786 ↗