LEGION 71423247Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 00885556032633), received between Nov 11, 2020 and Feb 21, 2026 — classified as 3 injuries, 1 malfunction.

The most frequently reported specific device problem is “Expiration Date Error” (1 report).

1 other recall cover devices cleared under the same FDA submission (K073325, K230653); they may or may not involve this specific model.

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 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• InjuryFeb 21, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT, AFTER A TKA SURGERY PERFORMED ON AN UNKNOWN DATE, THE PATIENT FELL AND OPENED THE SURGICAL INCISION SITE. THE SURGEON DECIDED TO EXPLANT A LGN POROUS CR FEM SZ 7L, A LGN CRHF XLPE INS W/JRNY LCK SZ 5-6 10MM, AND A POROUS TIBIA BASEPLATE WJRNY LOCK SZ6 LT AND PUT IN A TEMPORARY DEVICE TO PREVENT FURTHER INFECTION. CURRENT PATIENT'S HEALTH STATUS IS UNKNOWN, PATIENTS WAS IN GOOD HEALTH UPON COMPLETION OF SURGERY.

  Patient problems: Fall

  MAUDE report 24410382 ↗
• InjuryJul 31, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT, AFTER A TKA HAD BEEN PERFORMED WITH A LEGION SYSTEM ON (B)(6) 2022, THE PATIENT EXPERIENCED PAIN IN THE LEFT SIDE, DUE TO ARTHROFIBROSIS. THIS ADVERSE EVENT WAS TREATED WITH MANIPULATION UNDER ANESTHESIA. THE PATIENT OUTCOME WAS RECOVERED AND RESOLVED.

  Patient problems: Pain

  MAUDE report 15136944 ↗
• MalfunctionMay 18, 2021Expiration Date Error; Expiration Date Error

  IT WAS REPORTED THAT AFTER TKA SURGERY, IT WAS FOUND OUT THAT THE PATIENT COULD HAVE POSSIBLY RECEIVED A LGN POROUS CR FEM SZ 7L EXPIRED. HOWEVER, THE LABELING OF THE IMPLANT CONTAINS THE WRONG EXPIRATION DATE. IT WAS USE THE SAME S+N BACKUP DEVICE. NO PATIENT HARM OR OTHER COMPLICATIONS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11842214 ↗
• InjuryNov 11, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A PATIENT WAS UNSTABLE, A REVISION SURGERY WAS PERFORMED TO REMOVE AND REPLACE THE LGN POROUS CR FEM SZ 7L AND LEGION POROUS HA TIBIAL BASE SZ 6 LT WITH A STRYKER REVISION. NO OTHER INFORMATION AVAILABLE. PATIENT OUTCOME IS UNKNOWN. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED. IF ADDITIONAL INFORMATION SHOULD BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED ACCORDINGLY.

  Patient problems: Failure of Implant

  MAUDE report 10825053 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K073325, K230653. One submission often covers many models, so check the product and lot details in each record.

• Z-2621-2023 · Aug 31, 2023 · Open, Classified
  smith&nephew LEGION OXINUM POSTERIOR STABILIZED NONPOROUS FERMOAL COMPONENT, SIZE 5N, LEFT, NARROW, REF 71421265; knee joint