Triathlon 5532-G-513-ERecalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 07613327337914), received between Jun 25, 2020 and Jul 31, 2023 — classified as 2 injuries.

The most frequently reported specific device problem is “Insufficient Device Problem Information” (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 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.

• InjuryJul 31, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE FOLLOWING WAS REPORTED: "LEFT TOTAL KNEE POLY SWAP, DUE TO JOINT LAXITY . CONVERTED EXISTING POLY LINER TO A THICKER, MORE CONSTRAINED POLY LINER."

  Patient problems: Joint Laxity

  MAUDE report 17422734 ↗
• InjuryJun 25, 2020Insufficient Device Problem Information; Insufficient Device Problem Information

  THIS PI IS FOR THE PATIENT'S LEFT KNEE. IT WAS REPORTED THROUGH THE SUBMISSION OF CURRENT AND PREVIOUS REVISION USAGE SHEETS THAT THE PATIENT'S LEFT AND RIGHT KNEES WERE REVISED. A NOTE ON THE CURRENT REVISION USAGE SHEET STATES: "I&D BILATERAL KNEES." 5X13 PS INSERTS WERE SWAPPED FOR ANOTHER PAIR OF 5X13 PS INSERTS UPDATE PER RESPONSE: "ASKED TO BE SEEN BY ORTHO AND HAVE POLYETHYLENES EXCHANGED ONCE AGAIN TO AID IN THE BATTLE OF MRSA ETC. PATIENT CANNOT SPEAK DUE TO BEING IN A VENTILATOR BUT WE KNOW HIS KNEES WERE DONE IN (B)(6). NOTHING FURTHER TO REPORT PER HOSPITAL POLICY. "

  Patient problems: Injury

  MAUDE report 10193614 ↗

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-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-1262-2024 · Feb 6, 2024 · Open, Classified
  X3 TRIATHLON CS INSERT NO 7 9 MM
• 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-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