Triathlon 5516-F-301Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 07613327041545), received between Jun 27, 2017 and Jan 28, 2022 — classified as 3 injuries, 1 malfunction.

The most frequently reported specific device problem is “Insufficient Device Problem Information” (2 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 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• InjuryJan 28, 2022Loss of Osseointegration; Loss of Osseointegration

  PATIENT REPORTED SHE HAD A LEFT TKA ON (B)(6) 2018. PATIENT STATED THAT SINCE HER SURGERY SHE HAS EXPERIENCED SWELLING AND PAIN. PATIENT HAD X-RAYS DONE AND WAS TOLD BY HER SURGEON THAT HER KNEE WAS LOOSE AND SHE REQUIRES REVISION SURGERY.

  Patient problems: Inadequate Osseointegration; Pain; Swelling/ Edema

  MAUDE report 13382016 ↗
• InjuryDec 26, 2018Insufficient Device Problem Information; Insufficient Device Problem Information

  PERIPROSTHETIC FRACTURE. UPDATE (B)(4) 2018: REP PROVIDED IMPLANT DATE OF (B)(6) 2018 AND EXPLANT DATE OF (B)(6) 2018.

  Patient problems: Bone Fracture(s); Injury

  MAUDE report 8198155 ↗
• MalfunctionMar 8, 2018Device Contamination with Chemical or Other Material; Device Contamination with Chemical or Other Material

  IT WAS REPORTED THAT WHILE PERFORMING A PRIMARY LEFT KNEE PROCEDURE, THE FEMORAL COMPONENT HAD WHAT THE SURGEON REPORTED WAS A HAIR AND WAS LATER IDENTIFIED AS A FIBER ON THE IMPLANT. THE FIBER WAS FOUND AFTER IMPLANTATION. SURGEON REMOVED THE FIBER AND IRRIGATED. REP REPORTED THERE WAS NO SURGICAL DELAY, AND THE SURGEON FEELS THERE WAS NO PATIENT HARM.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7324649 ↗
• InjuryJun 27, 2017Insufficient Device Problem Information; Insufficient Device Problem Information

  SURGEON REVISED PATIENT'S KNEE FOR PAIN. SHE HAD A CEMENTLESS TRIATHLON KNEE. HER FEMORAL COMPONENT WAS REMOVED AND REPLACED WITH A CEMENTED TRIATHLON FEMUR. LEFT KNEE.

  Patient problems: Injury; Pain

  MAUDE report 6672154 ↗