Triathlon 5516-F-302Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 07613327040791), received between Jul 9, 2018 and Feb 19, 2020 — classified as 2 injuries, 1 malfunction.

The most frequently reported specific device problem is “Migration” (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 19, 2020Unstable; Unstable

  IT WAS REPORTED THAT THE PATIENT'S RIGHT KNEE WAS REVISED DUE TO INSTABILITY. THE PATIENT'S PS KNEE CONSTRUCT WAS REVISED TO A TS KNEE CONSTRUCT. REP REPORTED THAT NO FURTHER INFORMATION WILL BE AVAILABLE.

  Patient problems: Injury

  MAUDE report 9728335 ↗
• InjuryOct 18, 2019Migration; Migration

  THE PATIENT UNDERWENT RIGHT TOTAL KNEE REPLACEMENT (B)(6) 2019. IMAGING REVEALS PERIPROSTHETIC FRACTURE OF THE FEMUR (B2) OF KNEE WITH SUBSIDENCE AND MIGRATION OF THE IMPLANTS. THE PATIENT UNDERWENT KNEE REVISION OF FEMORAL LATERAL CONDYLE COMPONENT PATELLAR IMPLANT WAS RETAINED (B)(6) 2019.

  Patient problems: Bone Fracture(s); Injury

  MAUDE report 9211145 ↗
• MalfunctionJul 9, 2018Packaging Problem; Packaging Problem

  MR. (B)(6) FROM THE HOSPITAL REPORTED TO THE ANSM THE FOLLOWING EVENT: "TRANSPARENT PLASTIC CONTAINER BROKEN INSIDE THE CARTON (IMPLANT). ACTIONS TAKEN IN THE CARE FACILITY FOR PATIENT CARE: IMPLANT CHANGE."

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7669736 ↗