Triathlon 5515-F-101Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 07613327040685), received between Feb 4, 2021 and Apr 28, 2023 — classified as 3 injuries.

The most frequently reported specific device problem is “Insufficient Device Problem Information” (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.

• InjuryApr 28, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  JUST AFTER SURGERY WITH TRIATHLON PS, A FRACTURE WAS FOUND AT SUPERIOR LATERAL OF BOX. THE FRACTURE IS STABLE, BUT THE PATIENT HAS UNLOADED FOR 4 WEEKS JUST TO BE SAFE.

  Patient problems: Bone Fracture(s)

  MAUDE report 16831667 ↗
• InjurySep 20, 2021Insufficient Device Problem Information; Insufficient Device Problem Information

  IT HAS BEEN REPORTED "FRACTURES OF BOTH FEMORAL CONDYLE OCCURRED SINCE PS BOX IS HUGE."

  Patient problems: Bone Fracture(s); Limb Fracture

  MAUDE report 12502759 ↗
• InjuryFeb 4, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  AFTER THE LEFT TKA, LATERAL CONDYLE FRACTURED. PATIENT IS IN REHAB. SURGEON ASSUME THAT THIS EVENT OCCURRED BECAUSE OF POOR BONE QUALITY AND TOO MUCH OSTECTOMY. IS THERE ANY PROBLEM IN MAKING THE BOX?

  Patient problems: Bone Fracture(s)

  MAUDE report 11278485 ↗