Triathlon 5537-G-709Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 07613327027471), received between Jan 30, 2017 and Mar 2, 2021 — classified as 3 injuries.

The most frequently reported specific device problem is “Insufficient Device Problem Information” (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 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• InjuryMar 2, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT'S LEFT KNEE WAS REVISED DUE TO FLEXION CONTRACTURE. THE SURGEON REPORTED THAT THE PATIENT WAS KEPT IN FLEXION FOR SOME TIME AFTER A PREVIOUS ANKLE SURGERY, DATE AND DURATION NOT REPORTED. WHILE ADDRESSING THE FLEXION CONTRACTURE, THE SURGEON DECIDED TO SWAP 7X9 TS INSERT FOR ANOTHER 7X9 TS INSERT. THERE ARE NO ALLEGATIONS AGAINST THE INSERT. REP CONFIRMED THAT NO FURTHER INFORMATION WOULD BE RELEASED BY THE HOSPITAL OR SURGEON.

  Patient problems: Loss of Range of Motion

  MAUDE report 11398112 ↗
• InjuryJul 11, 2018Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED THAT A STAGE 1 REVISION WAS PERFORMED ON PATIENT'S RIGHT KNEE FOR INFECTION (INFECTION CLINICALLY CONFIRMED, SURGEON REPORTED THE INFECTING MICROORGANISM AS E. COLI), AFTER PATIENT COMPLAINT OF PAIN. A TIBIAL BASEPLATE, FEMORAL COMPONENT, PATELLA (IMPLANTED (B)(6) 2018) AND LINER (IMPLANTED (B)(6) 2018) WERE ALL EXPLANTED AND AN ANTIBIOTIC CEMENT SPACER PLACED.

  Patient problems: Injury; Pain; Unspecified Infection

  MAUDE report 7679427 ↗
• InjuryJan 30, 2017Insufficient Device Problem Information; Insufficient Device Problem Information

  INSERT SWAP DUE TO INFECTION. PATIENT HAD (B)(6) INFECTION.

  Patient problems: Injury; Unspecified Infection

  MAUDE report 6286374 ↗