Triathlon 5537-G-422Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 07613327027679), received between Jun 2, 2020 and Oct 30, 2020 — classified as 2 injuries.

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

• InjuryOct 30, 2020Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED THAT THE PATIENT'S LEFT KNEE WAS REVISED DUE TO PAIN. A 4X22 TS INSERT WAS REVISED TO A 4X25 TS INSERT. REP PROVIDED USAGE SHEETS AND CONFIRMED THAT NO FURTHER INFORMATION WILL BE RELEASED BY THE HOSPITAL OR SURGEON.

  Patient problems: Pain

  MAUDE report 10762899 ↗
• InjuryJun 2, 2020Insufficient Device Problem Information; Insufficient Device Problem Information

  POLY LINER SWAPPED FOR INFECTION. NO ADDITIONAL INFORMATION TO FOLLOW.

  Patient problems: Injury; Unspecified Infection

  MAUDE report 10108126 ↗