Triathlon 5537-G-416-ERecalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 07613327287745), received between Oct 18, 2021 and Oct 21, 2025 — classified as 5 injuries.

The most frequently reported specific device problem is “Device Dislodged or Dislocated” (1 report).

1 FDA recall record name this device's identifier, 1 still open.

6 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.

Recalls naming this device

1. Feb 6, 2024Class IIOpen, Classified

   Potential packaging breaches of inner blister and outer sterile blister.

   Z-1265-2024 · Root cause: Packaging · Recall details · FDA record ↗

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.

• InjuryOct 21, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE FOLLOWING INFORMATION WAS PROVIDED: AS PER PSS IMPLANT REQUEST: OTHER MECHANICAL COMPLICATION OF RIGHT KNEE PROSTHETIC. PATIENT HAS SEVERE ARTHROFIBROSIS, WE WOULD LIKE TO PLACE A SMALLER POLY, BUT IDEALLY ONE WITH SLOPE BUILT IN TO OPEN UP THE FLEXION SPACE MORE THAN THE EXTENSION SPACE AND HOPEFULLY AVOID REVISION OF A WELL-FIXED FEMORAL REVISION. WE WOULD LIKE A 14MM POLY FOR THE REPORTED SIZES WITH 4 DEGREES OF SLOPE BUILT IN TO THE POLY (ESSENTIALLY MAKING THE BACK FLEXION SPACE OF THE POLY APPROXIMATELY 11-12 MM, AND THE FRONT THE STANDARD 14 MM, TS IS PREFERENTIAL, IF POSSIBLE, BUT PS MAY BE ADEQUATE IF NOT POSSIBLE.

  Patient problems: Arthrofibrosis; Insufficient Information

  MAUDE report 23346351 ↗
• InjuryJul 23, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE FOLLOWING INFORMATION WAS PROVIDED: LEFT KNEE REVISION PERFORMED. PT. PRESENTED WITH WOUND DEHISCENCE FOLLOWING A LEFT KNEE REVISION ON 6/4/25 (NOTE: THIS WAS A REMOVAL OF A TEMPORARY SPACER). DR. OPTED TO PERFORM AN EXTENSIVE I&D AND INSERT SWAP. ALL OTHER COMPONENTS WET LEFT IN-SITE. NO COMPLAINTS HAVE BEEN FILED AGAINST THE COMPONENTS THEMSELVES, NO FURTHER INFO AVAILABLE.

  Patient problems: Insufficient Information

  MAUDE report 22584144 ↗
• InjuryMay 9, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT'S LEFT KNEE WAS REVISED DUE TO INFECTION. ALL IMPLANTS WERE REMOVED.

  Patient problems: Unspecified Infection

  MAUDE report 19282418 ↗
• InjuryAug 30, 2023Device Dislodged or Dislocated; Device Dislodged or Dislocated

  THE FOLLOWING WAS REPORTED: REVISION OF A LTK DUE TO DISLOCATION.

  Patient problems: Joint Dislocation

  MAUDE report 17654128 ↗
• InjuryOct 18, 2021Unstable; Unstable

  AS REPORTED: "PATIENT¿S [LEFT] FEMUR, POLY, FEMORAL STEM AND AUGMENTS REVISED DUE TO PAIN AND INSTABILITY. NO OTHER INFORMATION AVAILABLE DUE TO HOSPITAL POLICY."

  Patient problems: Ambulation or Postural Difficulties

  MAUDE report 12647866 ↗

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-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-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-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