Triathlon 5554-L-381Recalls & reported problems

Summary

The FDA's MAUDE database contains 9 adverse event reports that list this exact device (DI 07613327049916), received between Oct 25, 2018 and Jun 19, 2023 — classified as 9 injuries.

The most frequently reported specific device problem is “Noise, Audible” (4 reports).

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

• InjuryJun 19, 2023Detachment of Device or Device Component; Device Dislodged or Dislocated; Detachment of Device or Device Component; Device Dislodged or Dislocated

  IT WAS REPORTED THAT THE PATIENT'S LEFT KNEE WAS REVISED. AFTER BUMPING HIS KNEE ON HIS TRACTOR (DATE OF INCIDENT UNKNOWN), PATIENT EXPERIENCED CHRONIC PAIN IN THE KNEE. UPON SCOPING THE KNEE, THE POLY PORTION OF THE CEMENTED METAL-BACKED PATELLA WAS FOUND TO BE SEPARATED FROM THE METAL PORTION. THE PATELLAR COMPONENT AND INSERT WERE REVISED.

  Patient problems: Pain

  MAUDE report 17151115 ↗
• InjuryApr 6, 2022Device Dislodged or Dislocated; Naturally Worn; Unintended Movement; Device Dislodged or Dislocated; Naturally Worn; Unintended Movement

  IT WAS REPORTED THAT THE PATIENT'S RIGHT KNEE WAS REVISED. AS REPORTED: "KNEE PAIN AND GRINDING." A 9X3 CR INSERT AND A38 BEADED PATELLA WERE REVISED.

  Patient problems: Pain

  MAUDE report 14030115 ↗
• InjuryFeb 17, 2021Noise, Audible

  IT WAS REPORTED THAT THE PATIENT'S LEFT KNEE WAS REVISED DUE TO PAIN AND CLICKING. A TRIATHLON 8X11 CR TIBIAL BEARING AND A 38X11 ASYMMETRIC PATELLA WERE REVISED. REP CONFIRMED THAT NO FURTHER INFORMATION WOULD BE RELEASED BY THE HOSPITAL OR SURGEON AND EXPLANTS ARE HOSPITAL RETAINED.

  Patient problems: Pain

  MAUDE report 11339987 ↗
• InjuryDec 4, 2020Naturally Worn; Noise, Audible; Naturally Worn; Noise, Audible

  IT WAS REPORTED THAT THE PATIENT'S RIGHT KNEE WAS REVISED DUE TO CLICKING NOISE AND PAIN. REP CONFIRMED THAT THE SURGEON REPORTED THE PATELLAR COMPONENT WAS ARTICULATING AGAINST THE FEMORAL COMPONENT. THE PATELLAR COMPONENT AND INSERT WERE REVISED.

  Patient problems: Pain

  MAUDE report 10949480 ↗
• InjuryApr 6, 2020Unstable; Noise, Audible; Unstable; Noise, Audible

  AS REPORTED: "CLICKING AND ANTERIOR RIGHT KNEE PAIN. ALL AVAILABLE INFORMATION SUBMITTED." REP PROVIDED AN OFFICE NOTE WHICH REPORTS THE FOLLOWING: "HE HAS HAD PERSISTENT SWELLING IN THE KNEE PROBABLY SINCE SURGERY...DEVELOPED INCREASING DISCOMFORT AND SWELLING IN THE KNEE...A SMALL AMOUNT OF CORONAL INSTABILITY..." THE PATIENT'S INSERT AND PATELLAR COMPONENT WERE REVISED.

  Patient problems: Injury; Pain

  MAUDE report 9928571 ↗
• InjuryMar 9, 2020Noise, Audible; Noise, Audible

  IT WAS REPORTED THE PATIENT'S LEFT KNEE WAS REVISED. AS REPORTED BY THE REP: "CLICKING AND PAIN. ALL AVAILABLE INFORMATION SUBMITTED." AN 8X11 CR INSERT AND A38 BEADED PATELLA WERE REVISED.

  Patient problems: Injury; Pain

  MAUDE report 9805799 ↗
• InjuryMay 22, 2019Unstable; Unstable

  IT WAS REPORTED THROUGH THE COMMUNICATION OF AN ATTORNEY THAT ALLEGEDLY THE PATIENT WAS REVISED DUE TO "UNSTABLE LEFT TOTAL KNEE REPLACEMENT".

  Patient problems: Injury

  MAUDE report 8631829 ↗
• InjuryJan 9, 2019Naturally Worn; Naturally Worn

  IT WAS REPORTED THAT THE PATIENT'S LEFT KNEE WAS REVISED DUE TO PAIN IN THE ANTERIOR KNEE. AN A38 BEADED PATELLA WAS REVISED TO AN A38 X3 PATELLA.

  Patient problems: Injury; Pain

  MAUDE report 8232708 ↗
• InjuryOct 25, 2018Degraded; Material Separation; Degraded; Material Separation

  IT WAS REPORTED THAT PATIENT'S RIGHT KNEE WAS REVISED DUE TO PAIN.

  Patient problems: Injury; Pain

  MAUDE report 8006233 ↗