LEGION 71425204Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00885556108581), received between Apr 3, 2023 and Sep 1, 2023 — classified as 3 injuries.

1 other recall cover devices cleared under the same FDA submission (K091543, 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 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• InjurySep 1, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT, AFTER A TKA SURGERY THAT TOOK PLACE ON (B)(6) 2023 FOR A CLINICAL STUDY, THE PATIENT EXPERIENCED KNEE STIFFNESS. DOCTOR TREATED THIS ADVERSE EVENT BY LEFT KNEE MANIPULATION PROCEDURE PERFORMED ON (B)(6) 2023, HOWEVER, IT IS NOT CLEAR IF PATIENT IS RECOVERING.

  Patient problems: Loss of Range of Motion

  MAUDE report 17671423 ↗
• InjuryAug 3, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT AFTER A TKA SURGERY PERFORMED ON (B)(6) 2023, THE PATIENT EXPERIENCED STIFFNESS ON THE LEFT KNEE ON (B)(6) 2023. THIS ADVERSE EVENT WAS TREATED WITH PROCEDURE/SURGERY (KNEE MANIPULATION). PATIENT CURRENT HEALTH STATUS IS NOT RECOVERED.

  Patient problems: Loss of Range of Motion

  MAUDE report 17450635 ↗
• InjuryApr 3, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT, AFTER A TKA THAT HAD BEEN PERFORMED ON (B)(6) 2014, THE PATIENT EXPERIENCED A POSSIBLE LAXITY OF THE MCL AND HAD HOT SPOTS ON THE TIBIA. THIS WAS TREATED VIA A REVISION SURGERY ON (B)(6) 2023, IN WHICH THE IMPLANTED LGN POR CR HA FEM SZ 4 LT, LGN CR HIGH FLEX XLPE AND GNS II CMT TIB SIZE 2 LEFT WERE EXPLANTED. DURING THE SAME REVISION SURGERY IT WAS NOTICED THAT A SUBLUXATION OF THE FEMUR WAS CAUSING WEAR MEDIALLY ON THE POLYMER INSERT AND TIBIAL TRAY. CURRENT HEALTH STATUS OF PATIENT IS UNKNOWN, NO INFORMATION REGARDING THE PATIENT IS AVAILABLE.

  Patient problems: Subluxation

  MAUDE report 16663652 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K091543, 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