Triathlon 5532-P-609Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 07613327042856), received between Mar 14, 2017 and Aug 23, 2021 — classified as 2 injuries.

The most frequently reported specific device problem is “Insufficient Device Problem Information” (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 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• InjuryAug 23, 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 DUE TO INFECTION. SURGEON REPORTED POSSIBLE CAUSE/ CONTRIBUTOR FOR INFECTION WAS THE PATIENT'S USE OF HYDROGEN PEROXIDE AGAINST MEDICAL ADVICE. A WASHOUT WAS PERFORMED AND A 6X9 PS INSERT WAS REVISED TO A 6X11 PS INSERT (REP REPORTED THE REVISING SURGEON, WHO WAS NOT THE INDEX SURGEON, FELT THAT THE 11MM INSERT FIT THE PATIENT'S ANATOMY BETTER, THERE ARE NO ALLEGATIONS AGAINST THE REVISED INSERT). REP PROVIDED PRIMARY AND REVISION USAGE SHEETS, AND CONFIRMED THAT NO FURTHER INFORMATION WILL BE RELEASED BY THE HOSPITAL OR SURGEON.

  Patient problems: Unspecified Infection

  MAUDE report 12352718 ↗
• InjuryMar 14, 2017Insufficient Device Problem Information; Insufficient Device Problem Information

  SALES REP REPORTED A PRIMARY REVISION SURGERY OF RIGHT KNEE. THE POSTERIOR LOCKING MECHANISM DID NOT ENGAGE IN THE KNEE. THE DEVICE DID NOT FAIL, ALLEGEDLY THERE WAS NOT ENOUGH EXPOSURE. THERE WAS A 5 MINUTE DELAY.

  Patient problems: Injury

  MAUDE report 6404800 ↗