Triathlon 5551-G-401Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 07613327014839), received between Apr 5, 2018 and Dec 6, 2022 — classified as 3 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 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• InjuryDec 6, 2022Degraded; Naturally Worn; Degraded; Naturally Worn

  TRIATHLON TS FEMORAL REVISION PATIENT HAD COMPLAINED OF WORSENING PAIN. PREVIOUS TIBIAL REVISION IN 2019 IMPLANT DETAILS AVAILABLE FOR THAT SURGERY. DURING SURGERY WAS NOTED THE PATELLA HAD WEAR MARKS THIS WAS ALSO REPLACED.

  Patient problems: Pain

  MAUDE report 15922671 ↗
• InjuryApr 10, 2019Fracture; Fracture

  IT WAS REPORTED THAT THE PATIENT'S LEFT KNEE WAS REVISED DUE TO THE ALL-POLY PATELLAR COMPONENT SHEARING OFF. POSSIBLE CAUSE OR CONTRIBUTOR FOR IMPLANT SHEARING WAS NOT REPORTED, BUT THE SURGEON REPORTED HE BELIEVES THAT UNUSUAL FORCE WAS INVOLVED. REP CONFIRMED THE PATELLAR COMPONENT WAS CEMENTED WITH STRYKER CEMENT, AND REPORTED THAT NO FURTHER INFORMATION WILL BE AVAILABLE.

  Patient problems: Injury

  MAUDE report 8501118 ↗
• InjuryApr 5, 2018Insufficient Device Problem Information; Insufficient Device Problem Information

  PATIENT HAD PREVIOUS TRIATHLON KNEE REPLACEMENT SOME TIME IN 2009. A PATELLA PROCEDURE WAS DONE SOME TIME 2011. PATELLA PAIN BROUGHT PATIENT TO SEE A DOCTOR. REVISION DONE ON LEFT KNEE. UPDATE 23 MARCH 2018: A COMPLAINT HISTORY SEARCH HAS IDENTIFIED THAT THIS PATIENT HAD A REVISION SURGERY IN 2015 WHEREBY THE INSERT AND PATELLA WERE REVISED.

  Patient problems: Injury; Pain

  MAUDE report 7399166 ↗