INBONE 200011904Recalls & reported problems

Summary

The FDA's MAUDE database contains 7 adverse event reports that list this exact device (DI 00840420123916), received between Feb 14, 2022 and Dec 10, 2025 — classified as 7 injuries.

The most frequently reported specific device problem is “Osseointegration Problem” (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 7 most recent of 7 reports, in the reporter's own words as published by the FDA.

• InjuryDec 10, 2025Osseointegration Problem; Migration; Implant subsidence; Osseointegration Problem; Migration; Implant subsidence

  THE DIGITAL STRYKER PROPHECY TEAM RECEIVED A CT SCAN INDICATING THAT THE PATIENT HAS MULTIPLE FRACTURES IN THE TIBIA AND MAY REQUIRE A REVISION SURGERY DUE TO SUBSIDENCE OF THE TIBIAL COMPONENT AND THE IMPLANT TILTING INTO VARUS, CAUSING SIGNIFICANT PAIN.

  Patient problems: Extraskeletal ossification; Inadequate Osseointegration; Limb Fracture; Pain

  MAUDE report 23771550 ↗
• 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 22056570 ↗
• 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 21393238 ↗
• 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 17575128 ↗
• InjuryMar 10, 2023Osseointegration Problem; Migration; Osseointegration Problem; Migration

  IT WAS REPORTED THAT THE PATIENT UNDERWENT A TOTAL ANKLE REPLACEMENT. ALLEGEDLY, THE PATIENT MAY NEED TO UNDERGO A REVISION SURGERY DUE TO PAIN AND LOOSENING OF THE TIBIA STEM OF THE PROSTHESIS. NO OPERATING HAS BEEN DONE. THE PATIENT HAS BEEN GOING THROUGH PHYSICAL THERAPY WITH NO POSITIVE RETURNS.

  Patient problems: Implant Pain; Inadequate Osseointegration

  MAUDE report 16522467 ↗
• InjuryJun 27, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT HAD AN INFECTION AND UNDERWENT A PROCEDURE TO REMOVE THE IMPLANT. NO ADDITIONAL INFORMATION IS AVAILABLE AT THIS TIME.

  Patient problems: Unspecified Infection

  MAUDE report 14836514 ↗
• InjuryFeb 14, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT DURING A REVISION SURGERY THE PATIENT SUFFERED AN ANTERIOR MIDLINE FRACTURE OF THE TIBIA UPON IMPLANTATION OF THE TIBIAL STEMS. THE SURGEON USED A PLATE AND SCREWS TO TREAT THE FRACTURE. THE SURGEON EXPECTS THE PATIENT TO RECOVER WELL AND WILL PROCEED WITH NON-WEIGHT BEARING FOR 8 WEEKS.

  Patient problems: Bone Fracture(s)

  MAUDE report 13529273 ↗