Triathlon 5531-G-311-ERecalls & reported problems

Summary

The FDA's MAUDE database contains 11 adverse event reports that list this exact device (DI 07613327337013), received between Sep 30, 2020 and Jul 17, 2026 — classified as 10 injuries, 1 malfunction.

The most frequently reported specific device problem is “Insufficient Device Problem Information” (3 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 11 most recent of 11 reports, in the reporter's own words as published by the FDA.

• InjuryJul 17, 2026Fracture

  THE FOLLOWING INFORMATION WAS PROVIDED: IT WAS REPORTED THAT THE PATIENT'S RIGHT KNEE WAS REVISED DUE TO A POSTERIOR MEDIAL PIECE OF THE CS INSERT BEING BROKEN OFF. NO TRAUMA WAS REPORTED TO THE REP. NO DAMAGE WAS REPORTED TO THE FEMORAL COMPONENT OR THE BASEPLATE. ALL PIECES OF THE INSERT WERE REMOVED, AND THE INSERT WAS REVISED. REP CONFIRMED IMAGES CAN BE PROVIDED. OTHERWISE, REP CONFIRMED THAT NO FURTHER INFORMATION WILL BE RELEASED BY THE HOSPITAL OR SURGEON.

  Patient problems: Insufficient Information

  MAUDE report 25857617 ↗
• MalfunctionJul 1, 2025Detachment of Device or Device Component; Detachment of Device or Device Component

  THE FOLLOWING WAS REPORTED "THERE WAS A 3X11 CS POLY (REF# 5531-G-311-E) OPENED UP, LOT# T01K5R WITH A EXPIRATION DATE OF 9/11/25. AS THE SURGEON GRABBED IT AND WAS ABOUT TO IMPLANT IT IN THE PATIENT, THE SILVER WIRE FELL OFF THE IMPLANT. I HAD TO GO AND GET ANOTHER."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22370308 ↗
• InjuryAug 26, 2024Unstable; Unstable

  IT WAS REPORTED THAT THE PATIENT'S RIGHT KNEE WAS REVISED DUE TO INSTABILITY. A 3X11 CS INSERT WAS REVISED TO A 3X14 CS INSERT. REP CONFIRMED THAT NO FURTHER INFORMATION WILL BE RELEASED BY THE HOSPITAL OR SURGEON.

  Patient problems: Joint Laxity

  MAUDE report 20064295 ↗
• InjuryJul 14, 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 TO PAIN. A PATELLAR COMPONENT AND INSERT WERE REVISED. REP CONFIRMED NO FURTHER INFORMATION IS AVAILABLE DUE TO HOSPITAL POLICY.

  Patient problems: Pain

  MAUDE report 19737583 ↗
• InjuryAug 9, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  "PT. PRESENTED WITH A DRAINING WOUND FOLLOWING A LEFT MAKO-TKA ON (B)(6) 2023. DR. OPTED TO PERFORM AN I&D AND INSERT-SWAP. NO COMPLAINTS FILED AGAINST THE COMPONENTS THEMSELVES, NO FURTHER INFO AVAILABLE." SPOKE TO REP. INFECTION WAS NOT CONFIRMED.

  Patient problems: Unspecified Infection

  MAUDE report 17494353 ↗
• InjuryOct 13, 2022Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IT WAS REPORTED BY THE SALES REP THAT SURGEON NOTIFIED ABOUT THE TKR REVISION IS NEEDED. REASON FOR REVISION DUE TO DISLOCATION

  Patient problems: Joint Dislocation

  MAUDE report 15593204 ↗
• InjuryNov 22, 2021Unstable; Unstable

  IT WAS REPORTED THE PATIENT'S LEFT KNEE WAS REVISED DUE TO INSTABILITY. A 3X11 CS INSERT WAS EXCHANGED FOR A 3X16 CS INSERT. REP CONFIRMED THAT NO FURTHER INFORMATION WILL BE RELEASED BY THE HOSPITAL OR SURGEON.

  Patient problems: Insufficient Information

  MAUDE report 12851862 ↗
• InjuryOct 22, 2021Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED THROUGH THE SUBMISSION OF A REVISION IMPLANT SHEET THAT THE PATIENT'S RIGHT KNEE WAS REVISED. NOTED ON THE FORM: "WASHOUT/ POLY EXCHANGE." SPOKE TO REP. A 3X11 CS INSERT WAS EXCHANGED FOR ANOTHER 3X11 CS INSERT DUE TO SUSPECTED INFECTION. REP PROVIDED THE PRIMARY AND REVISION USAGE SHEETS AND CONFIRMED THAT NO FURTHER INFORMATION WILL BE RELEASED BY THE HOSPITAL OR SURGEON.

  Patient problems: Unspecified Infection

  MAUDE report 12682001 ↗
• InjuryAug 3, 2021Insufficient Device Problem Information; Insufficient Device Problem Information

  DR. REVISED A LEFT TRIATHLON TOTAL KNEE. THE ORIGINAL SURGERY THE PATELLA WAS NOT RESURFACED. THE PATIENT SUBSEQUENTLY FELT A POP WEEKS LATER. SURGEON CONFIRMED THE ARTHROTOMY AND RETINACULUM WERE TORN SO HE REPAIRED THE TISSUE, RESURFACED THE PATELLA AND CHANGED THE TIBIAL INSERT FROM A 3X11 TO A 3X9 TO RELIEVE STRESS ON THE PATELLA DURING FLEXION. NO SIGNS OF INFECTION OR ALLEGATIONS AGAINST THE IMPLANTS.

  Patient problems: Tissue Breakdown

  MAUDE report 12271546 ↗
• InjuryJan 15, 2021Adverse Event Without Identified Device or Use Problem

  POLYETHYLENE SWAP FOR INFECTED KNEE.

  Patient problems: Unspecified Infection

  MAUDE report 11176505 ↗
• InjurySep 30, 2020Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED THAT THE PATIENT'S LEFT KNEE WAS REVISED AFTER THE PATIENT FELL IN PHYSICAL THERAPY AND RE-OPENED HER WOUND. SURGEON SAID THERE WERE NO ALLEGATIONS AGAINST THE IMPLANTS, BUT PROPHYLACTICALLY SWAPPED A 3X11 CS INSERT FOR THE SAME. REP PROVIDED PRIMARY AND REVISION USAGE INFORMATION, AND CONFIRMED THAT NO FURTHER INFORMATION WILL BE RELEASED.

  Patient problems: Insufficient Information

  MAUDE report 10604839 ↗

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-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-1265-2024 · 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-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