Triathlon 5537-G-211Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 07613327027044), received between Jan 31, 2022 and Apr 7, 2025 — classified as 3 injuries.

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

• InjuryApr 7, 2025Mechanical Problem; Adverse Event Without Identified Device or Use Problem; Mechanical Problem; Adverse Event Without Identified Device or Use Problem

  THIS IS FOR MUA ON (B)(6) 2016. LEFT KNEE. THIS IS A SUBJECT WHO IS ENTERED IN THE 76 - CONES REVISION STUDY WHO DURING THEIR 7-YEAR PHONE FOLLOW UP INDICATED THAT THEY ARE NOT SATISFIED WITH THEIR IMPLANTS; STATES 'NO PAIN, JUST DISCOMFORT, SWOLLEN, STIFF; SHE STATED SHE WAS UNABLE TO BEND IT OVER 90°'; SHE STATED SHE BEEN TRYING TO SOME YOGA AND STRETCHING EXERCISES FOR HER KNEE AND NOTHING GETTING BETTER FOR HER.' REFUSES CLINIC VISIT. (PRIOR HISTORY OF MUA (B)(6) 2016 FOLLOWING STUDY SURGERY ON (B)(6) 2016 FOR ARTHROFIBROSIS. CONCERN FOR MIDSHAFT TIBIAL FRACTURE (B)(6) 2021). STUDY SITE HAS PROVIDED ALL INFORMATION AVAILABLE.

  Patient problems: Loss of Range of Motion

  MAUDE report 21792679 ↗
• InjuryApr 3, 2025Mechanical Problem; Adverse Event Without Identified Device or Use Problem; Mechanical Problem; Adverse Event Without Identified Device or Use Problem

  THIS PI IS FOR THE RESULTS OF THE 7-YEAR PHONE FOLLOW-UP. LEFT KNEE. THIS IS A SUBJECT WHO IS ENTERED IN THE 76 - CONES REVISION STUDY WHO DURING THEIR 7-YEAR PHONE FOLLOW UP INDICATED THAT THEY ARE NOT SATISFIED WITH THEIR IMPLANTS; STATES 'NO PAIN, JUST DISCOMFORT, SWOLLEN, STIFF; SHE STATED SHE WAS UNABLE TO BEND IT OVER 90°'; SHE STATED SHE BEEN TRYING TO SOME YOGA AND STRETCHING EXERCISES FOR HER KNEE AND NOTHING GETTING BETTER FOR HER.' REFUSES CLINIC VISIT. (PRIOR HISTORY OF MUA (B)(6) 2016 FOLLOWING STUDY SURGERY ON (B)(6) 2016 FOR ARTHROFIBROSIS. CONCERN FOR MIDSHAFT TIBIAL FRACTURE (B)(6) 2021). STUDY SITE HAS PROVIDED ALL INFORMATION AVAILABLE.

  Patient problems: Fibrosis; Loss of Range of Motion; Scar Tissue; Swelling/ Edema

  MAUDE report 21761677 ↗
• InjuryJan 31, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT'S RIGHT KNEE WAS REVISED DUE TO INFECTION. THE SURGEON'S ORIGINAL PLAN WAS TO PERFORM A POLY SWAP, BUT DECIDED INTRA-OPERATIVELY TO PERFORM A STAGE 1 REVISION AND REMOVED ALL IMPLANTS.

  Patient problems: Unspecified Infection

  MAUDE report 13392147 ↗