Triathlon 5531-G-410-ERecalls & reported problems

Summary

The FDA's MAUDE database contains 17 adverse event reports that list this exact device (DI 07613327390452), received between Jun 5, 2019 and May 1, 2026 — classified as 17 injuries.

The most frequently reported specific device problem is “Unstable” (3 reports).

3 other recalls cover devices cleared under the same FDA submission (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 18, 2026.

Most reported problems

Recent adverse event reports

The 17 most recent of 17 reports, in the reporter's own words as published by the FDA.

• InjuryMay 1, 2026Adverse Event Without Identified Device or Use Problem

  THE FOLLOWING INFORMATION WAS PROVIDED: REVISED A RIGHT TRIATHLON CR/CS CEMENTLESS KNEE DUE TO INFECTION.

  Patient problems: Unspecified Infection

  MAUDE report 25054627 ↗
• InjuryMar 23, 2026Adverse Event Without Identified Device or Use Problem

  THE FOLLOWING INFORMATION WAS PROVIDED: IT WAS REPORTED THAT THE PATIENT'S RIGHT KNEE WAS REVISED DUE TO HEMATOMA AND POSSIBLE INFECTION. A POLY EXCHANGE OF A 4X10 CS INSERT WAS PERFORMED FOR ANOTHER. REP CONFIRMED THAT NO FURTHER INFORMATION WILL BE RELEASED BY THE HOSPITAL OR SURGEON.

  Patient problems: Unspecified Infection

  MAUDE report 24669056 ↗
• InjuryFeb 3, 2026Mechanical Problem

  THE FOLLOWING INFORMATION WAS PROVIDED: IT WAS REPORTED THAT THE PATIENT'S RIGHT KNEE WAS REVISED DUE TO ROM ISSUES. A DEBRIDEMENT WAS PERFORMED AND A 4X10 CS INSERT WAS REVISED TO A 4X9 CS INSERT. REP CONFIRMED THAT NO FURTHER INFORMATION WILL BE RELEASED BY THE HOSPITAL OR SURGEON.

  Patient problems: Loss of Range of Motion

  MAUDE report 24251651 ↗
• InjuryOct 17, 2025Unstable; Unstable

  LEFT KNEE REVISION, PATIENT COMPLAINED OF INSTABILITY IN THE KNEE. SURGEON SWAPPED THE INSERT, AND ALL OTHER COMPONENTS WERE LEFT IN-SITU AT THIS TIME. NO COMPLAINTS FILED AGAINST THE COMPONENTS THEMSELVES, AND NO FURTHER INFORMATION AVAILABLE.

  Patient problems: Joint Laxity

  MAUDE report 23323773 ↗
• InjuryFeb 13, 2025Adverse 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. AN I&D WITH WASHOUT AND POLY EXCHANGE WAS PERFORMED. REP CONFIRMED THAT NO FURTHER INFORMATION WILL BE RELEASED BY THE HOSPITAL OR SURGEON.

  Patient problems: Unspecified Infection

  MAUDE report 21375954 ↗
• InjuryOct 21, 2024Unstable; Unstable

  THIS PI IS FOR THE REVISION. PT. CALLED AND REPORTED THAT; THEY HAD A TOTAL KNEE REPLACEMENT DONE LAST YEAR, (B)(6) 2023. THEY WOULD LIKE TO KNOW IF THERE'S ANY RECALL ON THE MAKO TRIATHLON USED FOR THEIR PROCEDURE. ADDITIONAL INFO. (B)(6) 2024: PT REPORTED REVISION DUE TO LOOSENING, PAIN, AND SWELLING. INITIAL PROCEDURE - (B)(6) 2023. AS PER MEDICAL REVIEW: THE PREOPERATIVE AND POSTOPERATIVE DIAGNOSES WERE "FAILED LEFT KNEE REPLACEMENT SECONDARY TO INSTABILITY AND RECURRENT EFFUSIONS.".

  Patient problems: Joint Laxity; Pain; Swelling/ Edema

  MAUDE report 20491948 ↗
• InjuryJul 18, 2024Patient Device Interaction Problem; Patient Device Interaction Problem

  IT WAS REPORTED THAT A PATIENT HAD A KNEE REPLACEMENT AND EXPERIENCED AN ALLERGIC REACTION. PATIENT'S SPOUSE IS INQUIRING ABOUT THE SAFETY DATA SHEETS FOR THE PARTS TO IDENTIFY IF ANY MATERIALS CAUSED THE ALLERGIC REACTION.

  Patient problems: Foreign Body Reaction

  MAUDE report 19779111 ↗
• InjuryMar 14, 2024Detachment of Device or Device Component; Detachment of Device or Device Component

  REVISION OF RIGHT TOTAL KNEE REPLACEMENT. SURGEON NOTED POLY DISSOCIATION. ISSUE NOTICED POST IMPLANTATION.

  Patient problems: Joint Dislocation

  MAUDE report 18907297 ↗
• InjuryMar 6, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT REPORTED A LEFT KNEE PAIN AND MANIPULATION UNDER ANESTHESIA DUE TO LIMITED RANGE OF MOTION. PATIENT WOULD LIKE TO KNOW IF IMPLANTS ARE SUBJECT TO RECALL.

  Patient problems: Loss of Range of Motion; Pain

  MAUDE report 18845765 ↗
• InjuryMar 6, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT REPORTED LEFT KNEE PAIN AND SWELLING AND "KNEE IS OUT OF PLACE" AFTER MUA. PATIENT WOULD LIKE TO KNOW IF IMPLANTS ARE SUBJECT TO RECALL.

  Patient problems: Pain; Swelling/ Edema

  MAUDE report 18845685 ↗
• InjuryNov 16, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  POSTOP LEFT TKA PAIN AND ERYTHEMA. KNEE RED, PAIN, FEELS HOT. PAINFUL CALF, SWOLLEN.

  Patient problems: Erythema; Pain; Swelling/ Edema

  MAUDE report 18147224 ↗
• InjuryMay 1, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PERFORMED AN I&D WITH INSERT SWAP OF A LEFT TKA DUE TO INFECTION.

  Patient problems: Unspecified Infection

  MAUDE report 16850684 ↗
• InjuryFeb 8, 2023Unstable; Adverse Event Without Identified Device or Use Problem; Unstable; Adverse Event Without Identified Device or Use Problem

  PATIENT REPORTED PAIN, SWELLING & A LIMP IN HER RIGHT KNEE. PATIENT WOULD LIKE TO KNOW IF IMPLANTS ARE SUBJECT TO A RECALL.

  Patient problems: Ambulation or Postural Difficulties; Pain; Swelling/ Edema

  MAUDE report 16319034 ↗
• InjurySep 1, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT REPORTED PRIMARY LEFT TKA IN (B)(6) 2021 AND HAS REPORTED "TREMENDOUS" PAIN SINCE. PATIENT HAD A MANIPULATION IN (B)(6) 2021 AND HAS REPORTED CONTINUOUS PAIN. PATIENT WOULD LIKE TO KNOW IF IMPLANTS ARE SUBJECT TO A RECALL. THIS REPORT IS FOR PAIN AFTER MANIPULATION.

  Patient problems: Pain

  MAUDE report 15342535 ↗
• InjurySep 1, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT REPORTED PRIMARY LEFT TKA IN (B)(6) 2021 AND HAS REPORTED "TREMENDOUS" PAIN SINCE. PATIENT HAD A MANIPULATION IN (B)(6) 2021 AND HAS REPORTED CONTINUOUS PAIN. PATIENT WOULD LIKE TO KNOW IF IMPLANTS ARE SUBJECT TO A RECALL. THIS REPORT IS FOR MANIPULATION UNDER ANESTHESIA.

  Patient problems: Ambulation or Postural Difficulties; Pain

  MAUDE report 15342531 ↗
• InjuryFeb 25, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  AS REPORTED: "POLY WAS REVISED DUE TO QUAD TENDON REPAIR. SURGEON DECIDED TO SWAP THE POLY WHILE THEY WERE OPERATING ON KNEE. NO OTHER INFORMATION IS AVAILABLE PER HOSPITAL POLICY." A 4X10 CS INSERT WAS SWAPPED FOR ANOTHER OF THE SAME TYPE AND SIZE. LEFT KNEE.

  Patient problems: Muscle/Tendon Damage

  MAUDE report 13597457 ↗
• InjuryJun 5, 2019Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED THE PATIENT'S RIGHT KNEE WAS REVISED 9 DAYS AFTER IMPLANTATION. THE PATIENT WAS GETTING UP TO GO TO THE RESTROOM AND TORE HER MEDIAL COLLATERAL LIGAMENT. THE PATIENT'S CR/CS KNEE CONSTRUCT WAS REVISED TO A TS CONSTRUCT. THE PATELLA WAS NOT REVISED. REP PROVIDED THE PRIMARY IMPLANT SHEET, SURGEON NOTES, AND AN OPERATIVE REPORT AND REPORTED THAT NO FURTHER INFORMATION WILL BE AVAILABLE.

  Patient problems: Excessive Tear Production; Injury

  MAUDE report 8671777 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K173849. One submission often covers many models, so check the product and lot details in each record.

• 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-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