INBONE 220252905Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 00840420124333), received between Mar 15, 2022 and Feb 23, 2026 — classified as 3 injuries, 1 malfunction.

The most frequently reported specific device problem is “Loosening of Implant Not Related to Bone-Ingrowth” (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 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• MalfunctionFeb 23, 2026Positioning Failure

  THE TIBIAL TRAY DID NOT ENGAGE INTO A BASE, MORSE TAPER WAS DEFECTIVE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24421290 ↗
• InjuryAug 31, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE DIGITAL STRYKER PROPHECY TEAM RECEIVED A REPORT INDICATING THE NEED FOR A REVISION DUE TO PAIN, RESULTING IN THE REMOVAL OF ALL PRIMARY TAA IMPLANTS AND THE PLACEMENT OF A CEMENT SPACER.

  Patient problems: Implant Pain; Unspecified Infection

  MAUDE report 17660050 ↗
• InjuryJul 11, 2022Adverse 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. ALLEGEDLY, THE PATIENT MAY NEED TO UNDERGO A REVISION SURGERY FOR REASONS THAT ARE NOT AVAILABLE AT THE TIME OF THIS REPORT.

  Patient problems: Insufficient Information

  MAUDE report 14978050 ↗
• InjuryMar 15, 2022Appropriate Device Problem Term/Code Not Available; Loosening of Implant Not Related to Bone-Ingrowth; Appropriate Device Problem Term/Code Not Available; Loosening of Implant Not Related to Bone-Ingrowth

  IT WAS REPORTED THAT THE PATIENT UNDERWENT A LEFT ANKLE HARDWARE REMOVAL AND LEFT REVISION TOTAL ANKLE REPLACEMENT WITH POSSIBLE COLLATERAL LIGAMENT REPAIR WITH INTERNAL BRACE AND LEFT ACHILLES TENDON LENGTHENING ALL ON THE LEFT. THE PATIENT IS STATUS POST LEFT ANKLE REPLACEMENT 2019 BUT CONTINUES TO DEVELOP ARTHRITIS CHANGES PARTICULAR ALONG THE MEDIAL AND LATERAL GUTTER ALONG WITH PAIN AND REDUCED RANGE OF MOTION. THE PATIENT ALSO HAS SOME LOOSENING OF IMPLANT ON IMAGING. THE PATIENT ELECTED FOR REVISION REPLACEMENT WITH LARGER IMPLANT AND IS SCHEDULED FOR SURGERY (B)(6) 2021. THE REPORTS OVERALL HE IS DOING OK. HE REMAINS FOLLOWED WITH RHEUMATOLOGY FOR HIS RA WHICH HAS BEEN WELL CONTROLLED ON XELJANZ.

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Implant Pain; Loss of Range of Motion; Rheumatoid Arthritis

  MAUDE report 13776080 ↗