Triathlon 5515-F-201Recalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 07613327040708), received between Mar 9, 2018 and Jul 17, 2026 — classified as 5 injuries.

The most frequently reported specific device problem is “Insufficient Device Problem Information” (3 reports).

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 5 most recent of 5 reports, in the reporter's own words as published by the FDA.

• InjuryJul 17, 2026Loss of Osseointegration

  THE FOLLOWING INFORMATION WAS PROVIDED: REVISION OF PS FEMUR AND POLY DUE TO LOOSENING. REVISION TO TS FEMUR WITH CONE.

  Patient problems: Inadequate Osseointegration

  MAUDE report 25858075 ↗
• InjuryJul 29, 2019Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED BY SALES REPRESENTATIVE THAT PATIENT WAS OPERATED ON (B)(6) 2019 USING TKA TRIATHLON CEMENTED PROCEDURE. PATIENT EXPERIENCED PAIN AFTER THE OPERATION AND THE DOCTOR PERFORMED AN X- RAY. THE X-RAY RESULTS REVEALED A DISTAL FEMORAL FRACTURE, WHICH WAS CORRECTED BY REVISION SURGERY ON (B)(6) 2019 , THE REVISION SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: Bone Fracture(s); Injury; Pain

  MAUDE report 8837165 ↗
• InjuryMay 1, 2019Insufficient Device Problem Information; Insufficient Device Problem Information

  POSTOPERATIVE DIAGNOSIS: THE PATIENT UNDERWENT LEFT TOTAL KNEE REPLACEMENT (B)(6) 2018. PATIENT GOT LEFT DISTAL FEMORAL PERIPROSTHETIC FRACTURE. PATIENT UNDERWENT LEFT TOTAL KNEE REVISION OF ALL COMPONENTS (B)(6) 2018.

  Patient problems: Bone Fracture(s); Injury

  MAUDE report 8569580 ↗
• InjurySep 18, 2018Use of Device Problem; Use of Device Problem

  IT WAS REPORTED THAT WHEN RIGHT TKA SURGERY, THE SURGEON INCORRECTLY IMPLANTED THE LEFT FEMORAL IMPLANT. THIS EVENT WAS CONFIRMED XP AFTER SURGERY. IT IS NOT SCHEDULED TO REPLACE AT THIS TIME.

  Patient problems: Ambulation or Postural Difficulties

  MAUDE report 7887366 ↗
• InjuryMar 9, 2018Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED THAT AFTER IMPLANTATION, PATIENT COMPLAINED OF PAIN. A CT SCAN REVEALED A CONDYLAR FRACTURE TO FEMORAL PIN SIDE. SURGEON HAS NOT DETERMINED A METHOD OF RESOLUTION AS OF THE TIME OF REPORT

  Patient problems: Bone Fracture(s); Pain

  MAUDE report 7326511 ↗