INBONE 220224312ERecalls & reported problems

Summary

The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 00840420125132), received between Jan 9, 2023 and Mar 9, 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.

• 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  THE MANUFACTURER RECEIVED A REPORT FROM THE NATIONAL JOINT REGISTRY THAT CONTAINS UNPUBLISHED COLLECTED DATA ON THE USAGE AND THE OUTCOMES OF THE ANKLE JOINT REPLACEMENT.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 24544225 ↗
• 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 24390795 ↗
• InjuryNov 14, 2023Positioning Failure; Positioning Failure

  IT WAS REPORTED THAT THE ANTERIOR OF THE POLY WAS NOT FULLY SEATING AND WAS PULLING THE TIBIAL TRAY PORTION DOWNWARDS. THE SURGEON STATED THAT THE ANTERIOR LIP SEEMED LARGER THAN NORMAL.

  Patient problems: Insufficient Information

  MAUDE report 18130090 ↗
• 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 16627142 ↗
• 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 16224962 ↗
• 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 16126542 ↗