Triathlon 5531-G-416Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 07613327045833), received between Jul 1, 2019 and Sep 10, 2024 — 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.

• InjurySep 10, 2024Degraded; Degraded

  IT WAS REPORTED THE PATIENT'S KNEE WAS REVISED DUE TO "POLY WORN AND SHEARED OFF POSTERIOR."

  Patient problems: Insufficient Information

  MAUDE report 20178234 ↗
• InjuryAug 9, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT REPORTED CONTINUED PAIN AND SWELLING AFTER REVISION.

  Patient problems: Pain; Swelling/ Edema

  MAUDE report 17486130 ↗
• InjuryJul 10, 2019Insufficient Device Problem Information; Insufficient Device Problem Information

  THE DOCTOR REPORTS PATIENT STATUS POST LEFT KNEE WHICH WAS PERFORMED BY ANOTHER SURGEON IN THE AREA AND WHICH THE DOCTOR RESURFACED HER PATELLA ON (B)(6) 2019 DUE TO THE FACT THE PRIMARY KNEE PATELLA WAS NEVER RESURFACED. THE PATIENT NOW PRESENTS WITH A INFECTION IN WHICH THE DOCTOR HAS DECIDED TO WASH OUT, PERFORM A POLY EXCHANGE AND REMOVE A PLATE THAT WAS PREVIOUSLY IMPLANTED YET BY ANOTHER SURGEON. THE WASH OUT AND EXCHANGE WENT WITHOUT INCIDENT. NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: Injury; Unspecified Infection

  MAUDE report 8776991 ↗
• InjuryJul 1, 2019Naturally Worn; Naturally Worn

  DR. INFORMED ME OF A STRYKER KNEE REVISION WHERE HE REQUESTED A POLY EXCHANGE. DURING SURGERY HE DISCOVERED THAT THE POLY WAS WORN POSTERIORLY. HE WAS UNSATISFIED WITH STABILITY AFTER A TRIAL SO EXTRACTED THE FEMORAL COMPONENT.

  Patient problems: Injury

  MAUDE report 8748315 ↗