Triathlon 5530-G-609-ERecalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 07613327383133), received between Nov 17, 2021 and Nov 13, 2025 — classified as 3 injuries, 1 malfunction.

The most frequently reported specific device problem is “Difficult to Insert” (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 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• InjuryNov 13, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE FOLLOWING INFORMATION WAS PROVIDED: PATIENT HAD INITIAL RIGHT KNEE REPLACEMENT DONE (B)(6) 2025 AT (B)(6) HOSPITAL BY DR (B)(6) (OA: (B)(4)). PATIENT HAS PRESENTED WITH INFECTION IN KNEE AT (B)(6) HOSPITAL. ON (B)(6) 2025 ALL IMPLANTS IN RIGHT KNEE WERE ALL REMOVED AND A CEMENT SPACER PLACED. THIS IS THE FIRST STAGE OF A 2 STAGE REVISION. NO SURGICAL DELAY, IMPLANTS REMOVED WITHOUT FURTHER DAMAGE TO REMAINING BONE. SWABS, MICRO & HISTOLOGY SAMPLES ALL TAKEN FOR TESTING. PATIENT MALE, 79 YEARS. ADDITIONAL INFORMATION PROVIDED 23/10/2025: THERE WERE NO IMPLANTS IMPLANTED YESTERDAY. ONLY A CEMENT SPACER WITH ANTIBIOTICS, WHICH WILL BE REVISED IN 6-8 WEEKS, PENDING THE RESOLUTION OF THE INFECTION.

  Patient problems: Unspecified Infection

  MAUDE report 23543750 ↗
• InjuryOct 30, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT'S RIGHT KNEE WAS REVISED. THE PATIENT HAD FALLEN 2 DAYS POST-PRIMARY, THE PATIENT FELL AND THE SURGICAL WOUND RE-OPENED. SURGEON DECIDED TO EXCHANGE THE INSERT AS A PROPHYLACTIC MEASURE. REP CONFIRMED THAT NO FURTHER INFORMATION WILL BE RELEASED BY THE HOSPITAL OR SURGEON.

  Patient problems: Fall

  MAUDE report 18033598 ↗
• InjuryMar 3, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A STAGE 1 REVISION WAS PERFORMED ON THE PATIENT'S RIGHT KNEE DUE TO INFECTION. ALL IMPLANTS WERE REMOVED AND AN ANTIBIOTIC SPACER WAS PLACED.

  Patient problems: Unspecified Infection

  MAUDE report 13660955 ↗
• MalfunctionNov 17, 2021Difficult to Insert; Difficult to Insert

  DURING POLY IMPACTION SURGEON COULD NOT LOCK THE POLY TRIATHLON MECHANISM INTO THE TIBIA. THE POLY WAS REMOVED AND INSPECTED AND IMPACTED AGAIN. AT SECOND ATTEMPT POLY APPEARED SEATED AND LOCKED. POST OP X-RAY SHOWED ISSUE WITH LOCKING MECHANISM.

  Patient problems: Insufficient Information; No Clinical Signs, Symptoms or Conditions

  MAUDE report 12827842 ↗

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-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-1263-2024 · Feb 6, 2024 · Open, Classified
  NO 3 TRIATHLON TS PLUS TIB INS X3 POLY 11 MM
• Z-1264-2024 · Feb 6, 2024 · Open, Classified
  NO 4 TRIATHLON TS PLUS TIB INS X3 POLY 11 MM
• Z-1261-2024 · Feb 6, 2024 · Open, Classified
  X3 TRIATHLON CS INSERT NO 6 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