Triathlon 5534-A-616Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 07613327043365), received between Jan 31, 2020 and Jan 31, 2020 — classified as 1 injury.

The most frequently reported specific device problem is “Insufficient Device Problem Information” (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 31, 2020Insufficient Device Problem Information; Insufficient Device Problem Information

  POSTOPERATIVE DIAGNOSIS: PATIENT UNDERWENT RIGHT TOTAL KNEE REPLACEMENT (B)(6) 2016. PATIENT UNDERWENT RESECTION OF ALL COMPONENTS, AND IMPLANTATION OF A FUNCTIONAL SPACER FOR RIGHT JOINT INFECTION (B)(6) 2019. REPORTED AS CORS PER 5960KNEE. PATIENT HAD RECURRENCE OF INFECTION AND WAS REVISED (ALL COMPONENTS TO AN OFF-LABEL USE COMPONENTS) IN (B)(6) 2019.

  Patient problems: Injury; Unspecified Infection

  MAUDE report 9653982 ↗