Triathlon 5530-P-613Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 07613327041897), received between Sep 14, 2023 and Nov 28, 2023 — classified as 2 injuries.

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

• InjuryNov 28, 2023Degraded; Degraded

  THE TIBIAL INSERT WAS PITTED AND DELAMINATED BOTH MEDIALLY AND LATERALLY. IT WAS ALSO DISCOLORED.

  Patient problems: Insufficient Information

  MAUDE report 18222823 ↗
• InjurySep 14, 2023Degraded; Naturally Worn; Degraded; Naturally Worn

  THE FOLLOWING WAS REPORTED: "I HAVE A KNEE REVISION WITH A SURGEON COMING UP. IT IS A TRIATHLON KNEE PUT IN 5 YEARS AGO AND THE INSERT (POLYETHYLENE) HAS FAILED. PARTS OF THE INSERT ARE COMPLETELY WORN AWAY AND CHUNKS OF IT HAVE COME OFF. THE REVISION WILL BE DONE IN A COUPLE OF MONTHS (DATE STILL TBC) AND THE SURGEON PLANS TO REMOVE THE CURRENT INSERT AND REPLACE IT WITH A NEW ONE OF THE SAME SIZE."

  Patient problems: Insufficient Information

  MAUDE report 17750692 ↗