LEGION 71423255Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 00885556031964), received between Nov 13, 2017 and Oct 10, 2025 — classified as 4 injuries.

The most frequently reported specific device problem is “Loosening of Implant Not Related to Bone-Ingrowth” (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 18, 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.

• InjuryOct 10, 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 (B)(6) 2019, THE PATIENT EXPERIENCED A DEEP VEIN THROMBOSIS IN THE RIGHT LOWER EXTREMITY ON (B)(6) 2019. THIS ADVERSE EVENT WAS TREATED USING MEDICATION THERAPY. THE OUTCOME OF THE EVENT IS THAT THE ADVERSE EVENT WAS RESOLVED AND THE PATIENT RECOVERED. THIS ADVERSE EVENT WAS IDENTIFIED DURING A CLINICAL STUDY.

  Patient problems: Thrombosis/Thrombus

  MAUDE report 23265740 ↗
• InjuryFeb 27, 2024Loosening of Implant Not Related to Bone-Ingrowth; Loosening of Implant Not Related to Bone-Ingrowth

  IT WAS REPORTED THAT, AFTER A TKA SURGERY PERFORMED ON (B)(6) 2022, ONE (1) LGN POROUS CR FEM SZ 5R WAS LOOSE. THIS ADVERSE EVENT WAS SOLVED BY A REVISION SURGERY ON 31-JAN-2024, IN WHICH THE IMPLANTS WERE REMOVED AND REPLACED WITH CEMENTED REVISION KNEE IMPLANTS. IT IS UNKNOWN THE CURRENT HEALTH STATUS OF PATIENT.

  Patient problems: Insufficient Information

  MAUDE report 18792034 ↗
• InjuryNov 13, 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, ON (B)(6) 2023 THE PATIENT COMPLAINT OF PERSISTENT STIFFNESS. THE PATIENT UNDERWENT A RIGHT TOTAL KNEE ARTHROPLASTY MANIPULATION UNDER ANESTHESIA. KNEE WAS ASPIRATED AT TIME OF PROCEDURE AND PATIENT RECEIVED AN INTRAARTICULAR STEROID INJECTION. PATIENT CURRENT HEALTH STATUS IS UNKNOWN.

  Patient problems: Loss of Range of Motion

  MAUDE report 18119782 ↗
• InjuryNov 13, 2017Unintended Movement; Unintended Movement

  IT WAS REPORTED THE PATIENT PRESENTED WITH A PREOPERATIVE DIAGNOSIS OF A FAILED RIGHT TOTAL KNEE ARTHROPLASTY. THE PATIENT HAD ISSUES IN RECOVERY INCLUDING POTENTIAL WOUND INFECTION, ARTHROFIBROSIS REQUIRING MANIPULATION, AND ON-GOING KNEE DISCOMFORT WITH PAIN AND SWELLING. BONE SCAN WAS POSITIVE AT THE DISTAL FEMUR, PROXIMAL TIBIA, POTENTIALLY CONSISTENT WITH ASEPTIC LOOSENING. THE PATIENT UNDERWENT A REVISION ARTHROPLASTY OF FEMORAL AND TIBIAL COMPONENTS, AND OPEN REDUCTION AND INTERNAL FIXATION OF A FRACTURE OF THE LATERAL FEMORAL CONDYLE. PROCEDURE INCLUDED PRESERVATION OF THE EXISTING PATELLAR POLY.

  Patient problems: Bone Fracture(s); Pain; Post Operative Wound Infection; Swelling

  MAUDE report 7026735 ↗

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