NA 86-7442Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 10603295217985), received between Aug 2, 2018 and Apr 23, 2026 — classified as 4 injuries.

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.

• InjuryApr 23, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT PATIENT WAS PRESENTED WITH PAIN IN FLEXION. IT WAS FOUND THAT THE HINGE COMPONENT WAS LOOSE. IT WAS REVISED TO A DFR. DOI- (B)(6) 2023. DOR- (B)(6) 2026. AFFECTED SIDE-RIGHT KNEE.

  Patient problems: Joint Laxity; Pain

  MAUDE report 24966486 ↗
• InjurySep 24, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PATIENT WAS REVISED TO ADDRESS INFECTION. DOI: (B)(6) 2020, DOR: (B)(6) 2020, RIGHT KNEE.

  Patient problems: No Code Available; Unspecified Infection

  MAUDE report 10584203 ↗
• InjuryFeb 20, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT WAS REVISED ON (B)(6) 2019 TO ADDRESS PAIN AND LOOSENING OF THE MBT REVISION COMPONENTS AT THE BONE TO CEMENT AND BONE TO IMPLANT INTERFACE IN THE RIGHT KNEE. DEPUY CEMENT WAS USED. ALL COMPONENTS OF TC3 MBT REVISION WERE REMOVED. THE ORIGINAL IMPLANT DATE WAS (B)(6) 2016.

  Patient problems: No Code Available; Pain

  MAUDE report 8353394 ↗
• InjuryAug 2, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  REVISION OF KNEE ARTHROPLASTY. PATIENT CONSEQUENCE? UNKNOWN. PATIENT CONSEQUENCE DESCRIPTION: PAIN AND DIFFICULT TO WALK. ACTION TAKEN FOR PROCEDURE: CULTURES TAKEN. IS THE INFORMATION BEING SUBMITTED FOR THIS COMPLAINT ALL THE DETAILS THAT ARE KNOWN/AVAILABLE REGARDING THIS EVENT? YES.

  Patient problems: Pain

  MAUDE report 7741881 ↗