Triathlon 5535-A-211Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 07613327043501), received between Oct 13, 2024 and Oct 13, 2024 — classified as 1 injury.

The most frequently reported specific device problem is “Mechanical Problem” (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 16, 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.

• InjuryOct 13, 2024Mechanical Problem; Mechanical Problem

  THIS PI IS FOR THE MUA ON (B)(6) 2018. SUBJECT HAD A PRIMARY APT RIGHT TKA AS PART OF A BILATERAL PROCEDURE ON (B)(6) 2018. AT THE 3-MONTH POST OP VISIT TAKING PLACE ON (B)(6) 2018 IT WAS OBSERVED THAT ROM HAD NOT IMPROVED AND AN MUA WAS SCHEDULED FOR AND OCCURRED ON (B)(6) 2018 (MUA WAS A BILATERAL PROCEDURE). TWO WEEKS FOLLOWING THE MUA ON (B)(6) 2018 IT WAS OBSERVED THAT ROM HAD IMPROVED. AT THE 6 WEEK FOLLOW UP CLINIC VISIT 0N (B)(6) 2018, IT WAS OBSERVED THAT THE ROM HAD NOT IMPROVED AND WORSENED SLIGHTLY. BETWEEN THAT VISIT AND THE NEXT VISIT, 5-YEAR IT WAS OBSERVED THAT THE SUBJECT SUSTAINED A FEMORAL FRACTURE WHICH WAS FIXATED WITH A NAIL ON (B)(6) 2019. AT THE 5-YEAR VISIT OCCURRING ON (B)(6) 2023 THE SUBJECT CONTINUE TO HAVE DECREASED ROM BUT OPTED TO CONSERVATIVELY TREAT. SUBJECT STATED THAT SHE FELT IT WAS DUE TO THE FRACTURE THAT SHE WAS UNABLE TO OBTAIN IMPROVED ROM IN THE RIGHT KNEE.

  Patient problems: Loss of Range of Motion

  MAUDE report 20436153 ↗