INBONE™ EVERLAST™ 22022208Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00889797074865), received between Nov 4, 2024 and Feb 18, 2025 — classified as 2 injuries, 1 malfunction.

The most frequently reported specific device problem is “Biocompatibility” (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 18, 2026.

Most reported problems

Recent adverse event reports

The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• 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 21400425 ↗
• MalfunctionNov 5, 2024Positioning Failure; Positioning Failure

  IT WAS REPORTED THAT DURING AN INBONE TAR REVISION SURGERY, THE SELECTED REPLACEMENT POLY DID NOT FIT THE INSERTION DEVICE , DESPITE BEING UNDAMAGED AND UNUSED. A SECOND POLY WAS OPENED, FIT PROPERLY, AND WAS SUCCESSFULLY IMPLANTED. THE INCIDENT CAUSED AN APPROXIMATE 10-MINUTE SURGICAL DELAY, WITH NO ADVERSE CONSEQUENCES REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20605939 ↗
• InjuryNov 4, 2024Naturally Worn; Naturally Worn

  IT WAS REPORTED THAT THE PATIENT UNDERWENT A TOTAL ANKLE REVISION SURGERY. THE POLY THAT WAS REMOVED HAD POSTERIOR WEAR ON IT. THE TIBIAL AND TALAR COMPONENTS WERE INTACT SO THEY WERE NOT REPLACED. THE NEW POLY THAT WAS OPENED WOULD NOT FIT INTO THE INSERTER. THE PHYSICIAN ATTEMPTED TO FIT IT INTO BOTH THE LEFT AND RIGHT INSERTERS TO MAKE SURE IT WASN'T AN ISSUE WITH THE POLY INSERTER ITSELF, BUT IT WOULD NOT SLIDE INTO EITHER. ANOTHER POLY OF THE SAME SIZE WAS OPENED, AND IT FIT IN THE INSERTER.

  Patient problems: Insufficient Information

  MAUDE report 20605268 ↗