LEGION 71434264Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 03596010549624), received between Oct 5, 2021 and Aug 29, 2023 — classified as 2 malfunctions.

The most frequently reported specific device problem is “Crack” (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 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• MalfunctionAug 29, 2023Fracture; Fracture

  IT WAS REPORTED THAT, DURING A TKA SURGERY, WHILE INSERTING THE LEGION CON INS TRL 15MM SZ 7-8; BOTH POSTERIOR EDGES OF THE LEGION CON INS TRL 15MM SZ 7-8 BROKE INSIDE THE PATIENT. THE BROKEN PIECES WERE REMOVED FROM THE PATIENT, THE AREA WAS WASHED WITH SALINE, THE FLUID WAS SUCTIONED AND THE AREA WAS RECHECKED FOR DEBRIS. WHEN THE AREA WAS DETERMINED TO BE CLEAR, THE SURGERY CONTINUED AFTER A NON-SIGNIFICANT DELAY, WITH A S+N BACK-UP DEVICE. NO FURTHER COMPLICATIONS WERE REPORTED AS A CONSEQUENCE OF THIS PROBLEM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17643462 ↗
• MalfunctionOct 5, 2021Crack; Crack

  IT WAS REPORTED THAT ONE LEGION CON INS TRL 15MM SZ 7-8 HAS A CRACK IN THE REVISION TRIAL. AS THIS WAS NOTICED UPON FIELD INSPECTION, THERE WAS NOT PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12576346 ↗