Triathlon 5540-A-602Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 07613327015119), received between Jan 20, 2020 and Jan 20, 2020 — classified as 1 injury.

The most frequently reported specific device problem is “Loss of Osseointegration” (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.

• InjuryJan 20, 2020Loss of Osseointegration; Loss of Osseointegration

  IT WAS REPORTED THAT THE PATIENT'S RIGHT KNEE WAS REVISED. PRE-OP DIAGNOSIS WAS FOR SUSPECTED LOOSENING OF THE TIBIAL BASEPLATE. A PRE-OP X-RAY ALSO REVEALED THAT THE BOTTOM NUB OF THE BASEPLATE HAD BECOME UNTHREADED FROM THE BASEPLATE. INTRA-OPERATIVELY, LOOSENING OF THE FEMORAL COMPONENT WAS ALSO NOTED. THE PATIENT'S KNEE CONSTRUCT WAS REVISED TO A TS KNEE WITH STEMS, CONES, AND AUGMENTS. THERE ARE NO ALLEGATIONS AGAINST THE REVISED INSERT. THE REP BELIEVES HE MAY BE ABLE TO RETURN THE EXPLANTS, AND WILL TRY TO OBTAIN FURTHER INFORMATION.

  Patient problems: Inadequate Osseointegration; Injury

  MAUDE report 9608675 ↗