Triathlon 5550-G-278-ERecalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 07613327314823), received between Nov 12, 2020 and Mar 28, 2023 — classified as 2 injuries.

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

7 other recalls cover devices cleared under the same FDA submission (K172634); 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.

• InjuryMar 28, 2023Loss of Osseointegration; Noise, Audible; Loss of Osseointegration; Noise, Audible

  PATIENT REPORTED JOINT LOOSENING AND AUDIBLE NOISE FOLLOWING PRIMARY TRIATHLON LEFT KNEE SURGERY. PATIENT STATED THAT SYMPTOMS STARTED "IMMEDIATELY" FOLLOWING THE (B)(6) 2020 SURGERY AND THAT THE KNEE WAS"NEVER GOOD". PATIENT STATED SHE FEELS THE LOOSENING AND DID NOT STATE WHETHER HER SURGEON CONFIRMED THE LOOSENING. PATIENT STATED THAT THE JOINT NOISE IS HEARD WHEN SHE MOVES HER "TOES UP AND DOWN."

  Patient problems: Inadequate Osseointegration

  MAUDE report 16625576 ↗
• InjuryNov 12, 2020Fracture; Adverse Event Without Identified Device or Use Problem; Fracture; Adverse Event Without Identified Device or Use Problem

  PATIENT WHO PREVIOUSLY HAD A MAKO TOTAL KNEE REPLACEMENT HAD A FALL AND FRACTURED PATELLA. REPLACEMENT PATELLA WAS IMPLANTED.

  Patient problems: Fall

  MAUDE report 10828298 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K172634. One submission often covers many models, so check the product and lot details in each record.

• Z-1261-2024 · Feb 6, 2024 · Open, Classified
  X3 TRIATHLON CS INSERT NO 6 11 MM
• Z-1263-2024 · Feb 6, 2024 · Open, Classified
  NO 3 TRIATHLON TS PLUS TIB INS X3 POLY 11 MM
• Z-1262-2024 · Feb 6, 2024 · Open, Classified
  X3 TRIATHLON CS INSERT NO 7 9 MM
• Z-1264-2024 · Feb 6, 2024 · Open, Classified
  NO 4 TRIATHLON TS PLUS TIB INS X3 POLY 11 MM
• Z-1265-2024 · Feb 6, 2024 · Open, Classified
  NO 4 TRIATHLON TS PLUS TIB INS X3 POLY 16 MM
• Z-1266-2024 · Feb 6, 2024 · Open, Classified
  NO 4 TRIATHLON TS PLUS TIB INS X3 POLY 16 MM
• Z-1654-2023 · Apr 13, 2023 · Open, Classified
  TRIATHLON X3 TIBIAL BEARING INSERT PS #4 13MM Intended for knee replacement Catalog Number: 5532-G-413-E