Triathlon 5530-P-411Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 07613327041781), received between Mar 6, 2019 and Jan 9, 2020 — classified as 2 injuries.

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

• InjuryJan 9, 2020Fracture; Naturally Worn; Fracture; Naturally Worn

  IT WAS REPORTED THAT THE PATIENT'S RIGHT KNEE WAS REVISED DUE TO FAILURE OF THE POLY INSERT (REPORTED AS HAVING BEEN WORN COMPLETELY THROUGH). THE 4X11 CR POLY INSERT WAS REVISED TO A 4X11 X3 CR POLY INSERT. REP REPORTED HE HAS ADDITIONAL IMAGES AND THE EXPLANT FOR RETURN, AND CONFIRMED THAT NO FURTHER INFORMATION WILL BE AVAILABLE.

  Patient problems: Failure of Implant; Injury

  MAUDE report 9569768 ↗
• InjuryMar 6, 2019Naturally Worn; Naturally Worn

  AS REPORTED: "PATELLA RESURFACING AND TIBIAL BEARING POLY SWAP". SPOKE TO REP, WHILE PERFORMING A PRIMARY PATELLAR IMPLANT, SURGEON DECIDED TO REVISE THE 8-9 YEAR OLD LINER. NOTHING BEYOND NATURAL WEAR WAS NOTED, THERE ARE NO ALLEGATIONS AGAINST THE DEVICE. REP REPORTED THAT X-RAYS, MEDICAL RECORDS, AND ADDITIONAL INFORMATION ARE NOT AVAILABLE.

  Patient problems: Injury

  MAUDE report 8394334 ↗