Triathlon 5530-P-409Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 07613327041774), received between Jan 7, 2021 and Jun 15, 2023 — classified as 4 injuries.

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

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 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• InjuryJun 15, 2023Degraded; Fracture; Degraded; Fracture

  IT WAS REPORTED THAT "RJH JUST HAD A LINER REVISION ON A 77YR OLD MALE PATIENT APPROXIMATELY 1YR AFTER HIS PRIMARY TKA AND THE CR 4/9MM INSERT WAS BROKEN."

  Patient problems: Ambulation or Postural Difficulties; Insufficient Information

  MAUDE report 17133563 ↗
• InjuryJun 1, 2022Insufficient Device Problem Information; Insufficient Device Problem Information

  IT HAS BEEN REPORTED BY THE HEALTHCARE FACILITY THAT A PATIENT HAS CONTACTED THEM SAYING THAT THEIR "IMPLANTS WERE NOT RIGHT." THE HEALTHCARE FACILITY IS ASKING IF ANY OF THE IMPLANTS WAS PART OF A RECALL. A COMPETITOR'S BONE CEMENT WAS USED IN CONJUNCTION WITH STRYKER IMPLANTS.

  Patient problems: Insufficient Information

  MAUDE report 14564873 ↗
• InjuryMay 6, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED PATIENT WAS REVISED DUE TO INFECTION.

  Patient problems: Unspecified Infection

  MAUDE report 11787982 ↗
• InjuryJan 7, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  AS REPORTED: THE PATIENTS LEFT KNEE "WAS REVISED DUE TO THE PATIENT¿S COMPLAINT OF PAIN." PATIENT WAS REVISED. SPOKE TO REP, THERE WERE NO INTRA-OPERATIVE FINDINGS THAT WOULD HAVE CAUSED THE PAIN. EVERYTHING WAS WELL-FIXED AND LOOKED GOOD. A TRIATHLON CR FEMORAL COMPONENT AND TIBIAL BEARING, SIZE 4 TIBIAL COMPONENT, AND PATELLA WERE REVISED TO A TS KNEE CONSTRUCT WITH AUGMENTS. REP CONFIRMED THAT NO FURTHER INFORMATION WOULD BE RELEASED BY THE HOSPITAL OR SURGEON.

  Patient problems: Pain

  MAUDE report 11130195 ↗