Triathlon 5512-F-801Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 07613327026610), received between May 29, 2018 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 20319836 ↗
• InjuryMay 29, 2018Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED THAT PATIENT'S LEFT KNEE WAS REVISED DUE TO A FRACTURED CONDYLE AND LOST MCL (MEDIAL COLLATERAL LIGAMENT). REP REPORTED THAT NO DEVICES WERE LOOSE OR BROKEN.

  Patient problems: Bone Fracture(s); Injury

  MAUDE report 7550538 ↗