Triathlon 5530-G-209-ERecalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 07613327382990), received between Apr 13, 2023 and May 18, 2026 — classified as 3 injuries.

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

10 other recalls cover devices cleared under the same FDA submission (K172634, 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 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• InjuryMay 18, 2026Unstable; Adverse Event Without Identified Device or Use Problem

  THE FOLLOWING INFORMATION WAS PROVIDED: LEFT-KNEE-REVISION. PT. PRESENTED WITH "GLOBAL INSTABILITY" FOLLOWING A TKA. SURGEON SUSPECTED A FAILURE OF THE PT'S PCL WHICH WAS SPARED/RETAINED DURING HER TKA IN 2022. SURGEON OPTED TO SWAP THE X3 INSERT FROM A CR 2 X 9 MM TO A CS 2 X 11 MM. SUFFICIENT STABILITY WAS REESTABLISHED. NO COMPLAINTS FILED AGAINST THE COMPONENTS THEMSELVES, NO FURTHER INFO.

  Patient problems: Joint Laxity

  MAUDE report 25202372 ↗
• InjuryApr 22, 2026Degraded

  THE FOLLOWING INFORMATION WAS PROVIDED: THIS PI IS FOR ONE SIDE KNEE. POLY WEAR IN THE TRIATHLON KNEE IMPLANT SYSTEM. PATIENT GOT THE BILATERAL KNEE REPLACEMENT SURGERY DONE IN THE YEAR 2022, AS PER SURGEON THE RECENT X-RAY REPORTS SHOWED POLY WEAR ON BOTH SIDES. SINCE THE IMPLANTS ARE NOT YET TAKEN OUT, THE ADVERSE CONSEQUENCES, IF ANY, ARE YET TO BE KNOWN WITH THE DOCTOR'S DECISION ON FURTHER COURSE OF MEDICAL TREATMENT FOR THE PATIENT.

  Patient problems: Insufficient Information

  MAUDE report 24953587 ↗
• InjuryApr 13, 2023Use of Device Problem; Use of Device Problem

  AS REPORTED BY MPS, TKA CASE WAS COMPLETED ROBOTICALLY. I REALIZED AFTER THE CASE THAT I SELECTED THE WRONG SIZE CR INSERT. I HAD SHOWN THE SURGEON THE BOX AND HE APPROVED IT TO BE OPEN. HOWEVER, THE INSERT WAS A SIZE 2X9MM CR INSERT, AND HE HAD ALREADY IMPLANTED A SIZE 3 TRITANIUM TIBIAL BASEPLATE.THE SURGEON HAD IMPACTED THE INSERT, THOUGHT NOTHING WAS WRONG AND FINISHED THE PROCEDURE. APPROXIMATELY 2 HOURS LATER, I DISCOVERED THE ERROR IN SIZE CONGRUENCY. I NOTIFIED THE SURGEON AND HOSPITAL STAFF IMMEDIATELY. THE PATIENT WAS STILL IN THE FACILITY, SO SHORTLY THEREAFTER, THE PATIENT WAS BROUGHT BACK TO THE OR. THE SURGEON RE-EXPOSED THE KNEE AND EXCHANGED THE SIZE 2 INSERT FOR THE APPROPRIATE SIZE 3X9MM CR INSERT.

  Patient problems: Insufficient Information

  MAUDE report 16729906 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K172634, K173849. 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-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-1265-2024 · Feb 6, 2024 · Open, Classified
  NO 4 TRIATHLON TS PLUS TIB INS X3 POLY 16 MM
• Z-1259-2024 · Feb 6, 2024 · Open, Classified
  X3 TRIATHLON CS INSERT NO 3 10 MM
• Z-1260-2024 · Feb 6, 2024 · Open, Classified
  X3 TRIATHLON CS INSERT NO 6 10 MM
• Z-1264-2024 · Feb 6, 2024 · Open, Classified
  NO 4 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
• 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