Triathlon 5531-G-411-ERecalls & reported problems

Summary

The FDA's MAUDE database contains 10 adverse event reports that list this exact device (DI 07613327337433), received between Oct 23, 2020 and Jun 24, 2026 — classified as 9 injuries, 1 malfunction.

The most frequently reported specific device problem is “Insufficient Device Problem Information” (2 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 16, 2026.

Most reported problems

Recent adverse event reports

The 10 most recent of 10 reports, in the reporter's own words as published by the FDA.

• InjuryJun 24, 2026Fracture

  THE FOLLOWING INFORMATION WAS PROVIDED: OPERATION WAS REVISION OF PATELLA. WHEN THE SURGEON OPENED UP THE PATIENTS KNEE HE FOUND BROKEN BITS OF POLY IN THE KNEE. PATIENT ALSO COMPLAINED TO SURGEON SHE COULD FEEL LOOSE BITS IN HER KNEE.

  Patient problems: Insufficient Information

  MAUDE report 25610560 ↗
• InjuryOct 3, 2024Unstable; Unstable

  AS REPORTED: "REV LTKA W/ POLY EXCHANGE FOR INSTABILITY AND WENT TO A PS 4X13MM INSERT FROM CS 4X11MM." REP CONFIRMED NO FURTHER INFORMATION IS AVAILABLE FROM THE HOSPITAL OR SURGEON.

  Patient problems: Joint Laxity

  MAUDE report 20365063 ↗
• InjuryOct 30, 2023Unstable; Unstable

  PATIENT REPORTED A ROBOTIC ASSISTED LEFT PKR ON (B)(6) 2022 AND REPORTED EXPERIENCING TIGHTENING, STIFFNESS, INSTABILITY AND DIFFICULTY TO STAND FROM SITTING POSITION. PATIENT REPORTED DOCTOR NOTED FLEXION EXTENSION MISMATCH/GAP. PATIENT WOULD LIKE TO HAVE SESSION FILES. UPDATE PER FB COMMENT RECEIVED: "MY SURGEON SCREWED UP MY KNEE REPLACEMENT. I HAVE WHAT IS KNOW AS AN FELXATION EXTENSION MISMATCH. NOW I HAVE TO HAVE IT TOTALLY REDONE. WORST 2 YEARS OF MY LIFE AND I HAVEN'T EVEN HAD THE SECOND SURGERY YET."

  Patient problems: Ambulation or Postural Difficulties; Joint Laxity; Loss of Range of Motion; Pain

  MAUDE report 18033540 ↗
• InjurySep 20, 2023Adverse 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. A 4X11 CS INSERT WAS EXCHANGED FOR ANOTHER 4X11 CS INSERT. REP CONFIRMED THAT NO FURTHER INFORMATION WILL BE RELEASED BY THE HOSPITAL OR SURGEON.

  Patient problems: Unspecified Infection

  MAUDE report 17786494 ↗
• MalfunctionAug 22, 2023Detachment of Device or Device Component; Detachment of Device or Device Component

  WHILE PUTTING ON THE FINAL LINER, DR. NOTICED AN IMPROPERLY FIXED WIRE BLOCKING THE LINER IN THE TIBIA TRAY. THE PROTRUDING WIRE PREVENTED THE INSERT FROM LATCHING INTO THE IMPLANT. A NEW IMPLANT HAS BEEN OPENED. THE PROCEDURE WAS NOT PROLONGED AND THE PROCEDURE WAS COMPLETED WITH A POSITIVE RESULT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17593343 ↗
• InjuryMar 13, 2023Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED THAT THE PATIENT'S RIGHT KNEE WAS REVISED DUE TO THE JOINT FEELING TIGHT. A DEBRIDEMENT WAS PERFORMED AND A 4X11 CS INSERT WAS REVISED TO A 4X10 CS INSERT. REP CONFIRMED THAT NO FURTHER INFORMATION WILL BE RELEASED BY THE HOSPITAL OR SURGEON.

  Patient problems: Ambulation or Postural Difficulties

  MAUDE report 16535059 ↗
• InjuryNov 15, 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 SUSPECTED INFECTION. A 4X11 CS INSERT WAS EXCHANGED FOR ANOTHER 4X11 CS INSERT. REP CONFIRMED THAT NO FURTHER INFORMATION WILL BE RELEASED BY THE HOSPITAL OR SURGEON.

  Patient problems: Unspecified Infection

  MAUDE report 15802264 ↗
• InjuryJun 27, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT REPORTS PAIN AND CONTINUED LOSS OF MOBILITY AFTER REVISION SURGERY. PATIENT IS INQUIRING IF ANY PARTS WERE SUBJECT TO A RECALL.

  Patient problems: Ambulation or Postural Difficulties; Pain

  MAUDE report 14838350 ↗
• InjuryDec 7, 2021Material Discolored; Adverse Event Without Identified Device or Use Problem; Material Discolored; Adverse Event Without Identified Device or Use Problem

  TRIATHLON INSERT LINER CHANGE. WHEN THE LINER WAS REVISED THERE WAS YELLOW DISCOLORATION ON THE ARTICULAR SURFACE. WHEN SEEING THE YELLOW DISCOLOURATION ON POLY INSERT THAT HAD JUST BEEN TAKEN OUT IT WAS ASKED IF WE COULD DO SOME ANALYSIS ON IT. IN PARTICULAR TO INVESTIGATE OXIDATION.

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

  MAUDE report 12957342 ↗
• InjuryOct 23, 2020Insufficient Device Problem Information; Insufficient Device Problem Information

  THE FOLLOWING WAS REPORTED: POLY INSERT WAS REMOVED DURING I&D.

  Patient problems: Insufficient Information

  MAUDE report 10725039 ↗

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-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-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-1261-2024 · Feb 6, 2024 · Open, Classified
  X3 TRIATHLON CS INSERT NO 6 11 MM
• Z-1266-2024 · Feb 6, 2024 · Open, Classified
  NO 4 TRIATHLON TS PLUS TIB INS X3 POLY 16 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