Triathlon 5532-P-416Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 07613327042740), received between Apr 24, 2019 and Aug 13, 2019 — classified as 2 injuries.

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 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• InjuryAug 13, 2019Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED THAT A STAGE 1 REVISION WAS PERFORMED ON THE PATIENT'S LEFT KNEE DUE TO INFECTION (INFECTION REPORTED BY SURGEON. UNKNOWN IF CLINICALLY CONFIRMED, INFECTING MICROORGANISM UNKNOWN). ALL DEVICES WERE EXPLANTED AND A SPACER WAS PLACED. REP REPORTED THAT NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: Injury; Unspecified Infection

  MAUDE report 8887644 ↗
• InjuryApr 24, 2019Unstable; Unstable

  PATIENT CALLED STATING SHE HAD A RIGHT KNEE REPLACEMENT DONE ON (B)(6) 2013. SHE HAS BEEN EXPERIENCING PAIN, DISCOMFORT AND FEELS HER KNEE IS NOT STABLE. PATIENT WILL LIKE TO KNOW IF HER IMPLANTS WERE INVOLVED IN A RECALL. PATIENT IS SCHEDULED TO HAVE A REVISION ON (B)(6) 2019.

  Patient problems: Pain

  MAUDE report 8546686 ↗