LEGION 71425391Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00885556733776), received between May 30, 2023 and May 30, 2023 — classified as 1 injury.

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 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

• InjuryMay 30, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT, AFTER RIGHT TKA SURGERY HAD BEEN PERFORMED ON (B)(6) 2023. FOR THE CLINICAL STUDY: POROUS TKA, THE PATIENT EXPERIENCED ERYTHEMA. THIS ADVERSE EVENT WAS TREATED BY ASPIRATION TO EVALUATE FOR INFECTION AND ORAL ANTIBIOTICS ON (B)(6) 2023. ON (B)(6)2023, PATIENT WAS TAKEN TO THE OPERATING ROOM TO PERFORM A WASHOUT AND POLY EXCHANGE. PATIENT WAS NOT RECOVERED.

  Patient problems: Erythema; Post Operative Wound Infection

  MAUDE report 17022104 ↗