Triathlon 5531-G-110-ERecalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 07613327390773), received between Aug 1, 2023 and Jun 29, 2026 — classified as 1 injury, 1 malfunction.

The most frequently reported specific device problem is “Detachment of Device or Device Component” (1 report).

3 other recalls cover devices cleared under the same FDA submission (K173849); 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 16, 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.

• MalfunctionJun 29, 2026Detachment of Device or Device Component

  TIBIAL INSERT PIN LOOSELY ATTACHED DUE TO WHICH UNABLE TO LOCK INSERT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25658638 ↗
• InjuryAug 1, 2023Unintended Movement; Unintended Movement

  THE FOLLOWING WAS REPORTED: "REVISED A LEFT KNEE TRIATHLON CS INSERT FROM A 1X10 TO A 1X12 CS. PATIENT WAS EXPERIENCE PATELLA SUBLUXATION, SO HE DID SOME SOFT TISSUE RELEASES AND DECIDED TO UPSIZE THE POLY."

  Patient problems: Subluxation

  MAUDE report 17438222 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K173849. One submission often covers many models, so check the product and lot details in each record.

• Z-1260-2024 · Feb 6, 2024 · Open, Classified
  X3 TRIATHLON CS INSERT NO 6 10 MM
• Z-1259-2024 · Feb 6, 2024 · Open, Classified
  X3 TRIATHLON CS INSERT NO 3 10 MM
• Z-1653-2023 · Apr 13, 2023 · Open, Classified
  TRIATHLON X3 TIBIAL BEARING INSERT CS #3 12MM-Intended for knee replacement Catalog Number: 5531-G-312-E