LEGION 71425387Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00885556733745), received between Apr 22, 2022 and Jan 21, 2026 — classified as 1 injury, 1 malfunction.

The most frequently reported specific device problem is “Break” (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.

• MalfunctionJan 21, 2026Break

  IT WAS REPORTED THAT, DURING A TKA SURGERY, THE LOCKING MECHANISM OF THE LGN DD XLPE INS W/ JRNY LOCK SZ 7-8 9MM BROKE. THE SURGERY WAS COMPLETED, WITHOUT ANY DELAY, WITH A SIMILAR S+N BACK-UP PRODUCT. NO INJURIES WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24131846 ↗
• InjuryApr 22, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT AFTER A TKA PERFORMED ON (B)(6) 2022, THE PATIENT EXPERIENCE AN INFECTION AFTER 6 WEEKS. THE ADVERSE EVENT WAS ADDRESSED VIA REVISION SURGERY ON (B)(6) 2022 TO EXPLANT THE FEMUR, TIBIA, INSERT AND PATELLAR COMPONENTS. PATIENT'S CURRENT STATUS OF HEALTH IS UNKNOWN.

  Patient problems: Unspecified Infection

  MAUDE report 14181785 ↗