Triathlon 5610-F-502Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 07613327027815), received between Jan 31, 2018 and Feb 6, 2025 — classified as 2 injuries.

The most frequently reported specific device problem is “Fracture” (1 report).

1 other recall cover devices cleared under the same FDA submission (K071881, K082567, K203099); they may or may not involve this specific model.

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 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• InjuryFeb 6, 2025Fracture; Fracture

  IT WAS REPORTED BY THE CUSTOMER THAT "REVISION FROM A UNI KNEE TO A TOTAL KNEE DUE TO WEAR ON THE UNI POLYETHYLENE AND PROGRESSION OF DISEASE - UPON SURGICAL APPROACH NOTICED THAT THE FEMORAL COMPONENT WAS BROKEN".

  Patient problems: Insufficient Information

  MAUDE report 21323340 ↗
• InjuryJan 31, 2018Insufficient Device Problem Information; Insufficient Device Problem Information

  PATIENT CALLED AND STATED THAT SHE HAD A RIGHT KNEE IMPLANT ON (B)(6) 2016. SHE STATED THAT SHE EXPERIENCED COMPLICATIONS, PAIN AND SWELLING RIGHT FROM THE START AND IT NEVER WENT AWAY. SHE STATED THAT SHE HAD A REVISION ON (B)(6) 2017. THE PATIENT'S REVISION DOCTOR SAID THAT WHEN HE WENT IN THAT THE IMPLANT WAS "DANGLING".

  Patient problems: Injury; Pain; Swelling

  MAUDE report 7232078 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K071881, K082567, K203099. One submission often covers many models, so check the product and lot details in each record.

• Z-0869-2009 · Nov 25, 2008 · Terminated
  Triathlon PKR Insert X3 #1 LM/RL - 8mm, 5630-G-108, Lot code NXDMEE Triathlon PKR Insert X3 #1 RM/LL - 12mm, 5630-G-122, Lot Code M8JMEE Intended Use: - Moderately disabling