INBONE 220252904Recalls & reported problems

Summary

The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 00840420124326), received between Jan 9, 2023 and Jan 13, 2026 — classified as 6 injuries.

The most frequently reported specific device problem is “Insufficient Device Problem Information” (1 report).

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 6 most recent of 6 reports, in the reporter's own words as published by the FDA.

• InjuryJan 13, 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 24056832 ↗
• InjuryApr 26, 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

  MAUDE report 19195762 ↗
• 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 17712620 ↗
• InjuryMay 24, 2023Material Separation; Material Separation

  IT WAS REPORTED THAT THE X-RAY SHOWED DELAMINATION OF TRAY AND MEDIAL MAL FRACTURE. THE PHYSICIAN DID A POLY SWAP AND TREATED THE MEDIAL MAL FRACTURE.

  Patient problems: Bone Fracture(s); Failure of Implant

  MAUDE report 16996974 ↗
• 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 16225008 ↗
• 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 16126910 ↗