Triathlon 5535-A-409Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 07613327043570), received between Jan 8, 2025 and Jan 15, 2026 — classified as 4 injuries.

The most frequently reported specific device problem is “Unstable” (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 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• InjuryJan 15, 2026Unstable

  THE FOLLOWING INFORMATION WAS PROVIDED: THIS PI IS FOR THE RIGHT KNEE. AS NOTED ON THE 7 YR VISIT OF THE FOLLOW-UP QUESTIONNAIRE (COLLECTED VIA PHONE), THE SUBJECT NOTED NO TO THEIR SATISFACTION WITH THE KNEE REPLACEMENT. THE SUBJECT ALSO STATED THAT EXERCISE HAS CHANGED TO LOW-IMPACT ACTIVITIES THAT STILL PRODUCE SWELLING AND MILD PAIN. THE SUBJECT BELIEVES THAT THERE ARE BETTER TECHNIQUES THAT COULD HAVE BEEN USED ON HIM. THE SUBJECT EXPRESSED HE HAS TO WATCH FOR UNEVEN GROUND, AND REPORTS HIP IMBALANCES. THE SUBJECT ALSO REPORTS INFREQUENT DULL PAIN, STIFFNESS, AND MODERATE HIP PAIN. THE SUBJECT HAS NOT HAD SURGERY ON THE KNEE SINCE THE LAST STUDY VISIT/CONTACT. THERE ARE NO RADIOGRAPHS TO PROVIDE, OR PHYSICAL EXAM NOTES FROM PI.

  Patient problems: Joint Laxity; Pain; Swelling/ Edema

  MAUDE report 24079809 ↗
• InjuryJan 14, 2026Unstable

  THE FOLLOWING INFORMATION WAS PROVIDED: THIS PI IS FOR THE LEFT KNEE. AS NOTED ON THE 7 YR VISIT OF THE FOLLOW-UP QUESTIONNAIRE (COLLECTED VIA PHONE), THE SUBJECT NOTED NO TO THEIR SATISFACTION WITH THE KNEE REPLACEMENT. THE SUBJECT ALSO STATED THAT EXERCISE HAS CHANGED TO LOW-IMPACT ACTIVITIES THAT STILL PRODUCE SWELLING AND MILD PAIN. THE SUBJECT BELIEVES THAT THERE ARE BETTER TECHNIQUES THAT COULD HAVE BEEN USED ON HIM. THE SUBJECT EXPRESSED HE HAS TO WATCH FOR UNEVEN GROUND, AND REPORTS HIP IMBALANCES. THE SUBJECT ALSO REPORTS INFREQUENT DULL PAIN, STIFFNESS, AND MODERATE HIP PAIN. THE SUBJECT HAS NOT HAD SURGERY ON THE KNEE SINCE THE LAST STUDY VISIT/CONTACT. THERE ARE NO RADIOGRAPHS TO PROVIDE, OR PHYSICAL EXAM NOTES FROM PI.

  Patient problems: Joint Laxity; Pain; Swelling/ Edema

  MAUDE report 24073336 ↗
• InjuryJan 8, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THIS PI IS FOR THE RIGHT KNEE. PATIENT HAS BILATERAL KNEE IMPLANTS. AS NOTED ON THE 5 YR VISIT OF THE FOLLOW-UP QUESTIONNAIRE (ALL POLY TIBIA STUDY), THE SUBJECT NOTED NO TO THEIR SATISFACTION WITH THE KNEE REPLACEMENT. THE SUBJECT ALSO STATED THAT ITS A FAST CHANGING FIELD, MAYBE HE SHOULD HAVE WAITED BUT HE WAS IN SO MUCH PAIN, AND HIS KNEE SCANS SHOULD HAVE BEEN ASSESSED THOROUGHLY PRIOR TO SURGERY. THE SUBJECT ALSO NOTED NO TO THEIR SATISFACTION DURING THE 6YR FOLLOW-UP QUESTIONNAIRE (PERFORMED OVER THE PHONE), STATING HE HAS PAIN IN COLD FRONTS AND WHEN WALKING. THE SUBJECT EXPRESSED HE HAS CONTINUED PAIN IN HIS KNEES SINCE THE PROCEDURE, AND IT IS NOT WHAT HE THOUGHT IT WOULD BE. THE SUBJECT SPOKE ABOUT OTHER PROCEDURES AND DOCTORS HE RESEARCHED AFTER HIS PROCEDURE. THE SUBJECT HAS NOT HAD SURGERY ON THE KNEE SINCE THE LAST STUDY VISIT/CONTACT.

  Patient problems: Pain

  MAUDE report 21102470 ↗
• InjuryJan 8, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THIS PI IS FOR THE LEFT KNEE. PATIENT HAS BILATERAL KNEE IMPLANTS. AS NOTED ON THE 5 YEAR VISIT OF THE FOLLOW-UP QUESTIONNAIRE (ALL POLY TIBIA STUDY), THE SUBJECT NOTED NO TO THEIR SATISFACTION WITH THE KNEE REPLACEMENT. THE SUBJECT ALSO STATED THAT ITS A FAST CHANGING FIELD, MAYBE HE SHOULD HAVE WAITED BUT HE WAS IN SO MUCH PAIN, AND HIS KNEE SCANS SHOULD HAVE BEEN ASSESSED THOROUGHLY PRIOR TO SURGERY. THE SUBJECT ALSO NOTED NO TO THEIR SATISFACTION DURING THE 6 YEAR FOLLOW-UP QUESTIONNAIRE (PERFORMED OVER THE PHONE), STATING HE HAS PAIN IN COLD FRONTS AND WHEN WALKING. THE SUBJECT EXPRESSED HE HAS CONTINUED PAIN IN HIS KNEES SINCE THE PROCEDURE, AND IT IS NOT WHAT HE THOUGHT IT WOULD BE. THE SUBJECT SPOKE ABOUT OTHER PROCEDURES AND DOCTORS HE RESEARCHED AFTER HIS PROCEDURE. THE SUBJECT HAS NOT HAD SURGERY ON THE KNEE SINCE THE LAST STUDY VISIT/CONTACT.

  Patient problems: Pain

  MAUDE report 21102313 ↗