Triathlon 5532-P-409Recalls & reported problems

Summary

The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 07613327042764), received between Dec 4, 2019 and Jan 11, 2024 — classified as 6 injuries.

The most frequently reported specific device problem is “Unstable” (5 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 6 most recent of 6 reports, in the reporter's own words as published by the FDA.

• InjuryJan 11, 2024Unstable; Unstable

  IT WAS REPORTED THAT THE PATIENT'S RIGHT KNEE WAS REVISED DUE TO INSTABILITY. A 4X9 PS INSERT WAS REVISED TO A 4X14 PS INSERT. INTRA-OPERATIVELY, NOTHING WAS NOTED TO BE LOOSE, WORN, OR BROKEN.

  Patient problems: Joint Laxity

  MAUDE report 18491097 ↗
• InjurySep 20, 2022Unstable; Unstable

  IT WAS REPORTED THE PATIENT'S RIGHT KNEE WAS REVISED DUE TO GLOBAL INSTABILITY (REP CONFIRMED THAT THERE WERE NO ALLEGATIONS OF INACCURATE CUTS OR IMPLANT MALPOSITION FROM THE PRIMARY). A 4X9 PS INSERT WAS REVISED TO A 4X11 TS INSERT.

  Patient problems: Joint Laxity

  MAUDE report 15459736 ↗
• InjuryJul 22, 2022Degraded; Fracture; Unstable; Degraded; Fracture; Unstable

  THE FOLLOWING WAS REPORTED: PS INSERT REMOVAL AND REPLACEMENT OF NEW INSERT. ORIGINAL TKA OCCURRED APPROX. 12 YEARS AGO. PT PRESENTED WITH "MY KNEE FEELS LESS STABLE". PS INSERT POST HAS SNAPPED AND INSERT UPON REMOVAL PRESENTED YELLOW AND BRITTLE.

  Patient problems: Ambulation or Postural Difficulties

  MAUDE report 15089538 ↗
• InjuryJun 15, 2022Unstable; Adverse Event Without Identified Device or Use Problem; Unstable; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED BY THE SALES REP THAT SURGEON INFORMED THAT MEDIAL LAXITY AND HYPEREXTENSION WHEN PATIENT EXTEND HIS LEG DETECTED THROUGH CLINICAL FINDING UPON CLINIC APPOINTMENT. EXPLANTED DONE AND REPLACED WITH TS IMPLANTS ( REVISION SURGERY) THIS IS A FIRST REVISION SURGERY , THE PRIMARY SURGERY WAS DONE ON (B)(6) 2020. PATIENT OUTCOME ( AS OF 25 MAY 2022) : AS THE REVISION SURGERY JUST BEEN DONE, PATIENT IS RECOVERING WELL.

  Patient problems: Joint Laxity

  MAUDE report 14700882 ↗
• InjuryMar 25, 2021Unstable; Unstable

  IT WAS REPORTED THAT THE PATIENT'S LEFT KNEE WAS REVISED DUE TO GLOBAL INSTABILITY. A 4X9 PS INSERT WAS REVISED TO A 4X13 TS INSERT. REP PROVIDED USAGE FOR THE PRIMARY AND REVISION PROCEDURES, AND CONFIRMED THAT NO FURTHER INFORMATION WILL BE RELEASED BY THE HOSPITAL OR SURGEON.

  Patient problems: Joint Laxity

  MAUDE report 11572095 ↗
• InjuryDec 4, 2019Material Deformation; Naturally Worn; Material Deformation; Naturally Worn

  WHILST RESURFACING PATELLA OF EXISTING TRIATHLON TOTAL KNEE REPLACEMENT, SURGEON DECIDED TO REPLACE PS INSERT FOR A THICKER SIZE. ON REMOVAL, THE INSERT APPEARED TO HAVE PITTING ON ARTICULAR SURFACE AND UNEVEN SURFACE ON THE BACK OF THE PS INSERT POST.

  Patient problems: Injury

  MAUDE report 9411854 ↗