Triathlon 5550-L-391Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 07613327050240), received between Jan 12, 2021 and Sep 27, 2024 — classified as 2 injuries.

The most frequently reported specific device problem is “Device Dislodged or Dislocated” (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.

• InjurySep 27, 2024Device Dislodged or Dislocated; Device Dislodged or Dislocated

  THIS PI IS FOR ONGOING ISSUES AFTER REVISION. SUBJECT'S LEFT KNEE WAS CONVERTED FROM A COMPETITOR CONSTRUCT TO A TRIATHLON KNEE ON (B)(6) 2017. PATIENT THEN HAD DRAINAGE, HEMATOMA, EFFUSION, PAIN, SWELLING, SUBLUXATION OF PATELLA, INSTABILITY, DISLOCATION OF PATELLA (LATERALLY WITH FLEXION). ON (B)(6) 2018 AN 8X9 PS INSERT WAS REVISED TO AN 8X11 TS INSERT, AND A RETINACULUM REPAIR WAS PERFORMED. PATIENT DEVELOPED EFFUSIONS AND ONGOING PATELLAR DISLOCATIONS.

  Patient problems: Fibrosis; Joint Laxity; Joint effusion; Pain; Scar Tissue

  MAUDE report 20319842 ↗
• InjuryJan 12, 2021Loss of Osseointegration; Loss of Osseointegration

  AS REPORTED: "PATIENT PRESENTED WITH ANTERIOR [RIGHT] KNEE PAIN. SURGEON STATES CT INDICATES PATELLA MAY BE LOOSE & OSTEOLYSIS DUE TO PATELLA & INSERT WEAR. SURGEON REPLACED PATELLA AND INSERT."

  Patient problems: Inadequate Osseointegration; Pain

  MAUDE report 11156667 ↗