Triathlon 5531-G-309-ERecalls & reported problems

Summary

The FDA's MAUDE database contains 33 adverse event reports that list this exact device (DI 07613327336955), received between Sep 4, 2020 and Jul 13, 2026 — classified as 33 injuries.

The most frequently reported specific device problem is “Degraded” (4 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 25 most recent of 33 reports, in the reporter's own words as published by the FDA.

• InjuryJul 13, 2026Degraded

  THE FOLLOWING INFORMATION WAS PROVIDED: IT WAS REPORTED THAT THE PATIENT'S RIGHT KNEE WAS REVISED DUE TO POLY WEAR AND (PER SURGEON) 'SOME' PAIN. A 3X9 CS INSERT WAS REVISED TO A 3X11 CS INSERT. SURGEON WOULD LIKE THE EXPLANT INVESTIGATED, AND WOULD LIKE THE INVESTIGATION RESULTS.

  Patient problems: Insufficient Information

  MAUDE report 25804136 ↗
• InjuryMay 28, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT'S RIGHT KNEE WAS REVISED DUE TO INFECTION. A WASH-OUT AND POLY EXCHANGE OF A 3X9 CS INSERT WAS PERFORMED. REP CONFIRMED THAT NO FURTHER INFORMATION WILL BE RELEASED BY THE HOSPITAL OR SURGEON.

  Patient problems: Unspecified Infection

  MAUDE report 25317025 ↗
• InjuryMay 28, 2026Adverse Event Without Identified Device or Use Problem

  THE FOLLOWING INFORMATION WAS PROVIDED: REVISED A RIGHT TRIATHLON CEMENTLESS KNEE DUE TO INFECTION. THE PATIENT HAD AN INSERT EXCHANGE BY ON (B)(6) 2025. DR. CEMENTED A TS FEMUR WITH AN ALL-POLY TIBIA AS A 1ST STAGE REVISION.

  Patient problems: Unspecified Infection

  MAUDE report 25315023 ↗
• InjuryApr 30, 2026Degraded; Fracture; Noise, Audible

  No new information.

  Patient problems: Ambulation or Postural Difficulties; Hyperextension; Joint Laxity; Pain

  MAUDE report 25044851 ↗
• InjurySep 8, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT IS S/P RIGHT POLY EXCHANGE DUE TO INFECTION. NO ADDITIONAL DETAILS WERE PROVIDED BY THE FACILITY.

  Patient problems: Unspecified Infection

  MAUDE report 22989894 ↗
• InjuryAug 22, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE FOLLOWING WAS REPORTED "I&D OF A LEFT KNEE TRIATHLON WITH TIBIAL INSERT EXCHANGE DUE TO INFECTION AND DID SOFT TISSUE RELEASING."

  Patient problems: Unspecified Infection

  MAUDE report 22874699 ↗
• InjuryAug 11, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  I&D OF A LEFT TRIATHLON FOR INFECTION WITH TIBIAL INSERT EXCHANGE. ORIGINALLY DONE ON (B)(6) 2024 AS A PRIMARY, THEN AN I&D WITH TIBIAL INSERT DONE ON (B)(6) 2024 FOR INFECTION.

  Patient problems: Unspecified Infection

  MAUDE report 22769579 ↗
• InjuryMar 19, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  RIGHT TOTAL KNEE. THE REVISION TODAY WAS SECONDARY TO INFECTION. THE ORIGINAL IMPLANTS WERE REMOVED, THE JOINT WAS COPIOUSLY WASHED OUT, AND NEW IMPLANTS WERE PLACED. NO FURTHER INFORMATION IS AVAILABLE FROM THE DOCTOR OR HOSPITAL.

  Patient problems: Unspecified Infection

  MAUDE report 21642868 ↗
• InjuryFeb 28, 2025Degraded; Naturally Worn; Degraded; Naturally Worn

  NO NEW INFORMATION.

  Patient problems: Insufficient Information

  MAUDE report 21496558 ↗
• InjuryFeb 24, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  I&D WITH A TIBIAL INSERT EXCHANGE OF A LEFT KNEE DUE TO INFECTION.

  Patient problems: Unspecified Infection

  MAUDE report 21444860 ↗
• InjuryNov 25, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT DEVELOPED INFECTION AT SOME POINT AFTER TOTAL KNEE REPLACEMENT. PATIENT CAME BACK IN FOR I&D AND POLY SWAP.

  Patient problems: Unspecified Infection

  MAUDE report 20770257 ↗
• InjurySep 11, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE FOLLOWING WAS REPORTED "I&D WITH TIBIAL INSERT EXCHANGE DUE TO INFECTION OF A LEFT TRIATHLON."

  Patient problems: Unspecified Infection

  MAUDE report 20194374 ↗
• InjurySep 6, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  I&D AND "POLY-SWAP" PERFORMED. PT. PRESENTED WITH A DRAINING SURGICAL WOUND FOLLOWING A RIGHT-TKA. DR. OPTED TO PERFORM AN EXTENSIVE I&D AND SWAP OUT THE X3 INSERT. NO COMPLAINTS HAVE BEEN FILED AGAINST THE COMPONENTS THEMSELVES, NO FURTHER INFO AVAILABLE.

  Patient problems: Wound Dehiscence

  MAUDE report 20155368 ↗
• InjuryAug 19, 2024Degraded; Mechanical Problem; Degraded; Mechanical Problem

  IT WAS REPORTED THAT THE PATIENT'S RIGHT KNEE WAS REVISED BECAUSE SCAR TISSUE WAS CAUSING ROM ISSUES (SURGEON REPORTED THIS WAS DUE TO THE PATIENT NOT GOING THROUGH PT). A 3X9 CS INSERT WAS EXCHANGED. REP CONFIRMED THAT NO FURTHER INFORMATION WILL BE RELEASED BY THE HOSPITAL OR SURGEON.

  Patient problems: Fibrosis; Loss of Range of Motion; Scar Tissue

  MAUDE report 20000029 ↗
• InjuryJul 8, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  SOFT TISSUE RELEASE AND OSTEOPHYTE REMOVAL WITH TIBIAL INSERT EXCHANGE ON A PATIENT THAT HAD LIMITED RANGE OF MOTION OF THE RIGHT KNEE. NO ALLEGATIONS AGAINST THE INSERT.

  Patient problems: Insufficient Information

  MAUDE report 19687691 ↗
• 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 RIGHT KNEE WAS REVISED DUE TO INFECTION. A 3X9 CS INSERT WAS REVISED. REP CONFIRMED THAT NO FURTHER INFORMATION WILL BE RELEASED BY THE HOSPITAL OR SURGEON.

  Patient problems: Unspecified Infection

  MAUDE report 19276980 ↗
• InjuryApr 23, 2024Mechanical Problem; Mechanical Problem

  THIS PI IS FOR THE REVISION OF THE PATIENT'S RIGHT KNEE ON (B)(6) 2021. IN PROVIDING INFORMATION FOR REVISION OF PATIENT'S RIGHT KNEE ON (B)(6) 2024, REP PROVIDED USAGE SHOWING THE PATIENT HAD A PRIOR REVISION (B)(6) 2021. REASON FOR REVISION WAS LACK OF ROM. A FEMORAL COMPONENT, INSERT, AND PATELLAR COMPONENT WERE REVISED. REP CONFIRMED THAT NO FURTHER INFORMATION WILL BE RELEASED BY THE HOSPITAL OR SURGEON.

  Patient problems: Loss of Range of Motion

  MAUDE report 19162772 ↗
• InjuryMar 28, 2024Adverse 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 INFECTION. A 3X9 CS INSERT WAS EXCHANGED FOR ANOTHER 3X9 CS INSERT. REP CONFIRMED THAT NO FURTHER INFORMATION WILL BE RELEASED BY THE HOSPITAL OR SURGEON.

  Patient problems: Unspecified Infection

  MAUDE report 18996905 ↗
• InjuryFeb 29, 2024Loss of Osseointegration; Adverse Event Without Identified Device or Use Problem; Loss of Osseointegration; Adverse Event Without Identified Device or Use Problem

  THE FOLLOWING WAS REPORTED "MY KNEE NEVER FULLY WORKED AFTER THE SURGERY AND THE IMPLANT BECAME LOOSE , MY KNEE WOULD BEND ALL THE WAY BACKWARDS , I¿VE FALLEN A FEW TIMES AND SO MUCH PAIN. I ALSO HAVE TO GET KNEE REPLACEMENT TO REPLACE THE IMPLANT AND CURRENTLY WEARING A BRACE. DID THERAPY AT HOME AND WITH THERAPIST. SCHEDULED SURGERY IN MARCH TO REPLACE THE ORIGINAL IMPLANT."

  Patient problems: Inadequate Osseointegration; Pain

  MAUDE report 18812915 ↗
• InjuryJan 2, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  EXPLANTED A CEMENTLESS TRIATHLON LEFT KNEE ORIGINALLY DONE ON (B)(6) 2023 AND THEN I&D ON (B)(6) 2023 DUE TO INFECTION. HE PLACED A STATIC SPACER.

  Patient problems: Unspecified Infection

  MAUDE report 18432583 ↗
• InjuryNov 24, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PERFORMED AN I&D WITH INSERT EXCHANGE ON A LEFT KNEE DUE TO POSSIBLE INFECTION.

  Patient problems: Unspecified Infection

  MAUDE report 18203341 ↗
• InjuryNov 2, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PERFORMED A SOFT TISSUE RELEASE AND CHANGED THE INSERT. RIGHT KNEE.

  Patient problems: Insufficient Information

  MAUDE report 18062474 ↗
• InjuryAug 16, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  REVISION SURGERY SECONDARY TO A FALL AND RUPTURE OF THE CAPSULAR REPAIR. IT WAS DECIDED TO TAKE OUT THE POLY TO THOROUGHLY WASHOUT THE JOINT. A NEW 9MM POLY WAS THEN PLACED AND THE CAPSULE WAS REPAIRED. NO FURTHER INFORMATION IS AVAILABLE FROM THE DOCTOR OR HOSPITAL.

  Patient problems: Fall

  MAUDE report 17557009 ↗
• InjuryJul 21, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  I&D POLY SWAP ON A RIGHT KNEE DUE TO INFECTION.

  Patient problems: Unspecified Infection

  MAUDE report 17369200 ↗
• InjuryJul 20, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  DR. REMOVED SCAR TISSUE AND REVISED A TIBIAL INSERT FROM A 3X9 CS TO A 3X10 CS ALL DUE TISSUE BALANCING.

  Patient problems: Scar Tissue

  MAUDE report 17359491 ↗

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-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-1261-2024 · Feb 6, 2024 · Open, Classified
  X3 TRIATHLON CS INSERT NO 6 11 MM
• Z-1263-2024 · Feb 6, 2024 · Open, Classified
  NO 3 TRIATHLON TS PLUS TIB INS X3 POLY 11 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