LEGION 71423257Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 00885556030769), received between Apr 19, 2022 and Nov 15, 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 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.

• InjuryNov 15, 2025Loosening of Implant Not Related to Bone-Ingrowth; Loosening of Implant Not Related to Bone-Ingrowth

  IT WAS REPORTED THAT, AFTER TKA SURGERY HAD BEEN PERFORMED ON (B)(6) 2023, THE PATIENT EXPERIENCED FEMORAL LOOSENING. THIS ADVERSE EVENT WAS SOLVED BY REVISION SURGERY ON (B)(6) 2025, DURING WHICH, THE LGN POROUS CR FEM SZ 7R AND LGN CRHF XLPE INS W/JRNY LCK SZ 5-6 9MM WERE EXCHANGED. THE PATIENT LEFT SURGERY IN GOOD HEALTH.

  Patient problems: Joint Laxity

  MAUDE report 23564233 ↗
• InjuryOct 30, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT, AFTER A TKA SURGERY WAS PERFORMED ON (B)(6) 2020, THE PATIENT EXPERIENCED A RIGHT KNEE ARTHROFIBROSIS. THIS CONDITION WAS TREATED WITH PHYSICAL/PHYSIOTHERAPY AND MANIPULATION UNDER ANESTHESIA. PATIENT'S CURRENT HEALTH STATUS IS RECOVERED/RESOLVED.

  Patient problems: Arthrofibrosis; Joint Contracture

  MAUDE report 23429619 ↗
• InjuryJul 28, 2022Loss of Osseointegration; Loss of Osseointegration

  IT WAS REPORTED THAT, AFTER AN INITIAL RIGHT TKA HAD BEEN PERFORMED ON (B)(6) 2012 DUE TO DEGENERATIVE JOINT DISEASE AND GENU VARUM MALALIGNMENT WITH MILD FLEXION CONTRACTURE OF THE RIGHT KNEE, THE PATIENT EXPERIENCED MECHANICAL LOOSENING OF THE JOINT. X-RAYS SHOWED THE TIBIAL COMPONENT HAD AN AUGMENT MEDIAL AND LATERAL AND AN EXTENDED STEM. PLAINTIFF UNDERWENT A RIGHT KNEE REVISION SURGERY ON (B)(6) 2019, WHERE NON-BONE INGROWN IN FEMORAL COMPONENT SURFACE WAS FOUND. THE PATELLA COMPONENT WAS RETAINED. PATIENT'S CURRENT HEALTH STATUS IS UNKNOWN.

  Patient problems: Deformity/ Disfigurement; Failure of Implant; Inadequate Osseointegration; Joint Laxity; Osteolysis

  MAUDE report 15123323 ↗
• InjuryApr 19, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT AFTER A TKA PERFORMED ON (B)(6) 2022, THE PATIENT EXPERIENCE AN INFECTION AFTER 6 WEEKS. THE ADVERSE EVENT WAS ADDRESSED VIA REVISION SURGERY ON (B)(6) 2022 TO EXPLANT THE FEMUR, TIBIA, INSERT AND PATELLAR COMPONENTS. PATIENT'S CURRENT STATUS OF HEALTH IS UNKNOWN.

  Patient problems: Unspecified Infection

  MAUDE report 14147789 ↗

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