Triathlon 5530-G-309-ERecalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 07613327382716), received between Oct 21, 2020 and Oct 9, 2024 — classified as 4 injuries.

The most frequently reported specific device problem is “Unstable” (2 reports).

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 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• InjuryOct 9, 2024Material Erosion; Fracture; Material Erosion; Fracture

  THE INSERT HAS FRACTURED NECESSITATING A REVISION AND REPLACEMENT OF THE INSERT.

  Patient problems: Insufficient Information

  MAUDE report 20409068 ↗
• InjuryFeb 20, 2023Unstable; Unstable

  IT WAS REPORTED THAT THE PATIENT'S LEFT KNEE WAS REVISED DUE TO PAIN AND INSTABILITY. SURGEON ORIGINALLY PLANNED TO REVISE A 3X9 CS INSERT WITH A 3X12 CS INSERT. HOWEVER, INTRA-OPERATIVELY THE SURGEON DECIDED TO CONVERT THE PATIENT TO A PS CONSTRUCT AND REVISED THE FEMUR AS WELL.

  Patient problems: Joint Laxity; Pain

  MAUDE report 16403316 ↗
• InjuryFeb 20, 2023Unstable; Adverse Event Without Identified Device or Use Problem; Unstable; Adverse Event Without Identified Device or Use Problem

  THIS PI IS FOR THE MANIPULATION UNDER ANESTHESIA (MUA) ON (B)(6) 2021. RECORDS PROVIDED BY THE REP FOR REVISION OF PATIENT'S LEFT KNEE ON (B)(6) 2021 INCLUDE AN OPERATIVE REPORT FOR AN MUA PERFORMED ON (B)(6) 2021 DUE TO PERSISTENT SCARRING AND 'TROUBLE REGAINING HER MOTION.' REP PROVIDED A 'PATIENT PACKET' AND CONFIRMED THAT NO FURTHER INFORMATION WILL BE RELEASED BY THE HOSPITAL OR SURGEON.

  Patient problems: Loss of Range of Motion

  MAUDE report 16402994 ↗
• InjuryOct 21, 2020Insufficient Device Problem Information; Insufficient Device Problem Information

  (B)(4) REFERRED PATIENT BACK TO SURGEON FOR POST OP PAIN THAT HE FELT WAS OUT OF PROPORTION TO USUAL KNEE SURGERY PAIN. PATIENT ALSO HAD A BRUISE. SURGEON ADDED TO SURGICAL LIST THAT DAY FOR A WASHOUT AND LINER CHANGE. SURGEON ALSO TOOK SAMPLES FOR FURTHER INFORMATION.

  Patient problems: Pain

  MAUDE report 10709900 ↗

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-1262-2024 · Feb 6, 2024 · Open, Classified
  X3 TRIATHLON CS INSERT NO 7 9 MM
• Z-1266-2024 · Feb 6, 2024 · Open, Classified
  NO 4 TRIATHLON TS PLUS TIB INS X3 POLY 16 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