LEGION 71425338Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00885556733172), received between Jun 19, 2025 and Jan 26, 2026 — classified as 2 injuries.

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.

• InjuryJan 26, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT, AFTER TKA SURGERY HAD BEEN PERFORMED ON (B)(6) 2025, THE PATIENT HIT HER KNEE ON A CABINET AND THIS OPENED HER SURGICAL WOUND SITE. THIS ADVERSE EVENT WAS TREATED BY A REVISION SURGERY ON (B)(6) 2025, IN WHICH THE SURGICAL SITE WAS WASHED OUT AND ONE (1) LGN CRHF XLPE INS W/JRNY LCK SZ 3-4 9MM WAS REPLACED TO HELP AVOID ANY INFECTION POSSIBILITIES. THE CURRENT HEALTH STATUS OF THE PATIENT IS UNKNOWN.

  Patient problems: Wound Dehiscence

  MAUDE report 24177089 ↗
• InjuryJun 19, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT, AFTER A TKA SURGERY HAD BEEN PERFORMED ON AN UNKNOWN DATE, THE PATIENT EXPERIENCED AN UNSPECIFIED ADVERSE EVENT. THIS ADVERSE EVENT WAS SOLVED BY A REVISION SURGERY ON (B)(6) 2025, IN WHICH ONE (1) LGN CRHF XLPE INS W/JRNY LCK SZ 3-4 9MM WAS EXCHANGED. THE PATIENT LEFT IN GOOD HEALTH.

  Patient problems: Insufficient Information

  MAUDE report 22292619 ↗