Triathlon 5610-F-601Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 07613327027822), received between Feb 21, 2022 and Feb 21, 2022 — classified as 1 injury.

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 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

• InjuryFeb 21, 2022Fracture; Fracture

  THE PATIENT RECEIVED A REMOVAL OF THE SLED PROSTHESIS DUE TO ASEPTIC LOOSENING ON (B)(6) 2021. DURING REMOVAL OF THE SLED PROSTHESIS, IT WAS NOTICED THAT THE FEMORAL PART WAS BROKEN.

  Patient problems: Ambulation or Postural Difficulties

  MAUDE report 13569308 ↗

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