Triathlon 5536-B-800Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 07613327041538), received between Sep 21, 2020 and Sep 21, 2020 — classified as 1 injury.

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 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

• InjurySep 21, 2020Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED THAT THE PATIENT'S RIGHT KNEE WAS REVISED DUE TO PAIN. A SIZE 8 BASEPLATE AND 8 X 9 CS INSERT WERE REVISED TO A UNIVERSAL BASEPLATE WITH AUGMENTS AND AN 8 X 12 CS INSERT. REP PROVIDED PRIMARY AND REVISION USAGE SHEETS AND AN EXPLANT PICTURE AND CONFIRMED THAT NO FURTHER INFORMATION WILL BE RELEASED.

  Patient problems: Pain

  MAUDE report 10560034 ↗