Triathlon 5566-S-012Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 07613327026856), received between Mar 11, 2019 and Jun 18, 2020 — classified as 2 injuries.

The most frequently reported specific device problem is “Break” (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.

• InjuryJun 18, 2020Loss of Osseointegration; Loss of Osseointegration

  IT WAS REPORTED THAT THE PATIENT'S RIGHT KNEE WAS REVISED DUE TO LOOSENING. REVISING SURGEON REPORTED THAT CAUSE OR CONTRIBUTOR TO LOOSENING WAS DUE TO THE PRIOR SURGEON NOT USING ENOUGH CEMENT. THE PATIENT'S ENTIRE KNEE CONSTRUCT WAS REVISED. REP PROVIDED EXPLANT PICTURES AND REPORTED THAT NO FURTHER INFORMATION WILL BE RELEASED BY THE HOSPITAL OR SURGEON.

  Patient problems: Injury

  MAUDE report 10166539 ↗
• InjuryMar 11, 2019Break; Break

  IT WAS REPORTED THAT THE PATIENT'S RIGHT KNEE WAS REVISED AFTER PATIENT COMPLAINT OF PAIN. INTRA-OPERATIVELY, THE TIBIAL BASEPLATE WAS NOTED TO BE LOOSE, AND THE FEMORAL COMPONENT BROKEN AT THE COMPONENT/STEM INTERFACE. THE BASEPLATE, FEMORAL COMPONENT, STEM, AND INSERT WERE REVISED. THERE ARE NO ALLEGATIONS AGAINST THE LINER, AND THE PATIENT'S PATELLAR IMPLANT WAS NOT REVISED. PATIENT WAS REVISED TO A UNIVERSAL BASEPLATE, TS FEMORAL COMPONENT, 2 STEMS, 2 OFFSET ADAPTERS, 8 AUGMENTS, AND TS INSERT. REP WILL BE PROVIDING A PATIENT PACKET AND REPORTED THAT NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: Injury; Pain

  MAUDE report 8407637 ↗