Triathlon 5530-G-509-ERecalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 07613327382617), received between Apr 9, 2021 and Jul 20, 2025 — classified as 3 injuries, 2 malfunctions.

The most frequently reported specific device problem is “Detachment of Device or Device Component” (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 5 most recent of 5 reports, in the reporter's own words as published by the FDA.

• MalfunctionJul 20, 2025Detachment of Device or Device Component; Detachment of Device or Device Component

  THE FOLLOWING WAS REPORTED "PRODUCT WAS OPENED AND I NOTICED THE LOCKING WIRE LOOSE ON ONE SIDE. IT WASN¿T USED. A NEW ONE WAS OPENED AND WORKED CORRECTLY."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22552247 ↗
• MalfunctionNov 24, 2023Device Damaged Prior to Use; Device Damaged Prior to Use

  IT WAS REPORTED BY THE SALES REP THAT THE TRIATHLON CR INSERT LOCKING WIRE IS LOOSEN WHEN SURGEON IMPACTING THE INSERT INTO THE IMPLANTED TRIATHLON TIBIA BASEPLATE. THE INSERT UNABLE TO LOCK PROPERLY WITHOUT THE LOCKING WIRE. A NEW INSERT WAS USED AS A REPLACEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18204300 ↗
• InjuryNov 7, 2022Fracture; Adverse Event Without Identified Device or Use Problem; Fracture; Adverse Event Without Identified Device or Use Problem

  PATIENT REPORTED PAIN IN KNEE. SURGEON DECIDED TO PERFORM A RESURFACING OF THE PRIMARY PATELLA DUE TO THE PROGRESSION OF THE DISEASE. THE POLY INSERT WAS EXCHANGED WHEN SURGEON WAS PERFORMING A RESURFACING OF PRIMARY PATELLA. THE SURGEON PERFORMED EXCHANGE AS A BEST PRACTICE TO REDUCE INFECTION RISK. WHEN POLY INSERT WAS REMOVED, IT WAS NOTICED THAT THERE WAS A NOTCH/IMPERFECTION ON THE RIM OF THE POLY INSERT. IT IS NOT CLEAR IF THIS WAS CAUSED BY IMPACTION OR BY FRICTION. UPDATE 31 OCTOBER 2022: THE PATIENT HAD A PRIMARY KNEE REPLACEMENT SOME TIME AGO, THE PATELLA WAS NOT DEEMED DISEASED ENOUGH TO RESURFACE AT THAT POINT SO WAS LEFT. THEN AFTER TIME THE PATIENT COMPLAINED OF PAIN AND IT WAS DETERMINED THE PATELLA HAD NOW BECOME AFFECTED BY OSTEOARTHRITIS AND NEEDED RESURFACING.

  Patient problems: Pain

  MAUDE report 15742502 ↗
• InjuryJun 28, 2022Adverse 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 DUE TO WOUND DRAINAGE (IT WAS NOT REPORTED TO THE REP WHETHER INFECTION WAS SUSPECTED OR NOT). AN I&D WAS PERFORMED AND A 5X9 CR INSERT WAS EXCHANGED FOR ANOTHER 5X9 CR INSERT.

  Patient problems: Insufficient Information

  MAUDE report 14839383 ↗
• InjuryApr 9, 2021Naturally Worn; Naturally Worn

  IT WAS REPORTED THAT THE PATIENT'S RIGHT KNEE WAS REVISED DUE TO PAIN. PRE-OPERATIVELY, THE SURGEON SUSPECTED THE CAUSE OF PAIN TO BE FEMORAL LOOSENING AND OSTEOLYSIS DUE TO POLY WEAR, DUE TO LUCENCY SEEN ON X-RAY. INTRA-OPERATIVELY, THOUGH NOTED TO NOT BE GROSSLY LOOSE, THE EXISTENCE OR DEGREE OF LOOSENESS OF THE CEMENTED FEMORAL COMPONENT WAS NOT REPORTED TO THE REP. THE POLY HAD NO VISIBLE WEAR. REP IS REQUESTING INVESTIGATION RESULTS ON THE INSERT, WHICH IS ALLEGEDLY BEING RETURNED. PATIENT WAS REVISED TO A SIZE 4 PS FEMUR WITH A 5X10 INSERT. REP CONFIRMED THAT NO FURTHER INFORMATION WILL BE RELEASED BY THE HOSPITAL OR SURGEON.

  Patient problems: Inadequate Osseointegration; Pain

  MAUDE report 11644025 ↗

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-1263-2024 · Feb 6, 2024 · Open, Classified
  NO 3 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-1264-2024 · Feb 6, 2024 · Open, Classified
  NO 4 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-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