Triathlon 5531-G-510-ERecalls & reported problems

Summary

The FDA's MAUDE database contains 9 adverse event reports that list this exact device (DI 07613327390636), received between May 24, 2021 and May 13, 2026 — classified as 9 injuries.

The most frequently reported specific device problem is “Unstable” (1 report).

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 16, 2026.

Most reported problems

Recent adverse event reports

The 9 most recent of 9 reports, in the reporter's own words as published by the FDA.

• InjuryMay 13, 2026Unstable

  IT WAS REPORTED THAT THE PATIENT'S RIGHT KNEE WAS REVISED DUE TO INSTABILITY. A 5 X 10 CS INSERT WAS EXCHANGED FOR A 5 X 12 CS INSERT. REP CONFIRMED THAT NO FURTHER INFORMATION WILL BE RELEASED BY THE HOSPITAL OR SURGEON.

  Patient problems: Joint Laxity

  MAUDE report 25159417 ↗
• InjuryMar 18, 2026Adverse Event Without Identified Device or Use Problem

  THE FOLLOWING INFORMATION WAS PROVIDED: THIS PI IS FOR THE REVISION OF A PRIMARY KNEE DUE TO INFECTION. IN PROVIDING INFORMATION FOR A REVISION OF THE PATIENT'S LEFT KNEE IN 2026, REP PROVIDED USAGE SHEETS FROM A 2023 PRIMARY KNEE, AND A 2024 REVISION. THE 2024 REVISION WAS A SECOND-STAGE REVISION OF A COMPETITOR CONSTRUCT DUE TO INFECTION. REP CONFIRMED THAT NO FURTHER INFORMATION WILL BE RELEASED BY THE HOSPITAL OR SURGEON.

  Patient problems: Unspecified Infection

  MAUDE report 24627539 ↗
• 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 A QUAD RUPTURE. A 5X10 CS INSERT WAS REVISED TO A 5X11 CS INSERT. REP CONFIRMED THAT NO FURTHER INFORMATION WILL BE RELEASED BY THE HOSPITAL OR SURGEON.

  Patient problems: Rupture

  MAUDE report 21379201 ↗
• InjuryApr 8, 2023Adverse 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. ALL IMPLANTS WERE REMOVED AND A SPACER WAS PLACED. REP CONFIRMED THAT NO FURTHER INFORMATION WILL BE RELEASED BY THE HOSPITAL OR SURGEON.

  Patient problems: Unspecified Infection

  MAUDE report 16705168 ↗
• InjuryApr 2, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  AS REPORTED: "PATIENT HAD TOTAL KNEE EXPLANT DUE TO POSSIBLE INFECTION. PATIENT HAD A POLY CEMENTED AS A KNEE SPACER ON TODAY'S SURGERY SHEET. NO OTHER INFORMATION AVAILABLE DUE TO HOSPITAL POLICY." SPOKE TO REP, WHO CONFIRMED ALL IMPLANTS WERE REMOVED.

  Patient problems: Unspecified Infection

  MAUDE report 16661042 ↗
• InjuryJan 25, 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 POSSIBLE INFECTION. A 5X10 CS INSERT WAS EXCHANGED. REP CONFIRMED THAT NO FURTHER INFORMATION IS AVAILABLE DUE TO HOSPITAL POLICY.

  Patient problems: Unspecified Infection

  MAUDE report 16241039 ↗
• InjuryJul 20, 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. AS REPORTED: "...PATIENT REPORTED THAT HE FELL DOWN AND A HEMATOMA APPEARED ON HIS KNEE WHERE HE HAD THE SURGERY. SURGEON DID AN IRRIGATION AND DEBRIDEMENT TODAY WHERE HE NOTICED WOUND SITE WASN'T PROPERLY CLOSED SO HE WASHED THE PATIENT OUT AND DID AN I&D AND SWAPPED THE POLY INSERT. A 5X10 CS INSERT WAS TAKEN OUT AND A 5X10 CS INSERT WAS PUT BACK IN. ORIGINAL LINER WAS DESTROYED AND THROWN AWAY."

  Patient problems: Fall; Hematoma

  MAUDE report 15063703 ↗
• InjurySep 22, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THROUGH THE SUBMISSION OF A REVISION IMPLANT SHEET THAT THE PATIENT'S LEFT KNEE WAS REVISED. NOTED ON THE FORM: "SWAP OUT POLY." SPOKE TO REP. REASON FOR REVISION WAS SUSPECTED INFECTION AND A TORN PATELLA TENDON. AN I&D WAS PERFORMED AND A 5X10 CS INSERT WAS REVISED TO A 5X9 CS INSERT. REP PROVIDED USAGE SHEETS FROM CURRENT AND PRIOR REVISION AND CONFIRMED THAT NO FURTHER INFORMATION WILL BE RELEASED BY THE HOSPITAL OR SURGEON.

  Patient problems: Unspecified Infection

  MAUDE report 12513928 ↗
• InjuryMay 24, 2021Adverse 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. SURGEON REPORTED THAT DUE TO THE PATIENT NOT ATTENDING PHYSICAL THERAPY, THE PATIENT DEVELOPED A FLEXION CONTRACTURE. A 5X10 CS POLY WAS EXCHANGED FOR A 5X9 CS POLY. REP SAID SHE MAY BE ABLE TO PROVIDE THE ORIGINAL IMPLANTATION DATE, AND OTHERWISE CONFIRMED NO FURTHER INFORMATION WILL BE RELEASED BY THE HOSPITAL OR SURGEON.

  Patient problems: Loss of Range of Motion

  MAUDE report 11872670 ↗

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-1260-2024 · Feb 6, 2024 · Open, Classified
  X3 TRIATHLON CS INSERT NO 6 10 MM
• Z-1259-2024 · Feb 6, 2024 · Open, Classified
  X3 TRIATHLON CS INSERT NO 3 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