LEGION 71423234Recalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 00885556031049), received between Oct 28, 2019 and Mar 30, 2023 — classified as 4 injuries, 1 malfunction.

The most frequently reported specific device problem is “Break” (1 report).

4 other recalls cover devices cleared under the same FDA submission (K060742, 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 5 most recent of 5 reports, in the reporter's own words as published by the FDA.

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

  IT WAS REPORTED THAT, AFTER A RIGHT TOTAL KNEE ARTHROPLASTY PERFORMANCE ON (B)(6) 2022 DUE TO STAGE IV OSTEOARTHRITIS OF THE RIGHT KNEE, ON THE 10TH DAY AFTER THE OPERATION (B)(6),THE PATIENT HAD RED, SWOLLEN, HOT AND EXUDATIVE WOUNDS. THE DRESSING WAS CHANGED, BUT THE WOUND HEALED POORLY. IN ORDER TO TREAT THIS, THE PATIENT UNDERWENT DEBRIDEMENT IN THE HOSPITAL. THE PATIENT HEALTH STATUS IS UNKNOWN.

  Patient problems: Impaired Healing; Inflammation; Purulent Discharge

  MAUDE report 16649699 ↗
• InjuryJul 21, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT, AFTER A TKA CONSTRUCT HAD BEEN IMPLANTED ON THE PATIENT'S KNEE ON (B)(6) 2022, THE PATIENT EXPERIENCED PAIN, STIFFNESS AND COULD NOT ACHIEVE FULL EXTENSION. A REVISION SURGERY WAS PLANNED AND PERFORMED ON (B)(6) 2022 TO TREAT THESE COMPLICATIONS. THE SURGEON INITIALLY PLANNED A PATELLA RESURFACING WITH A POLYETHYLENE INSERT EXCHANGE, BUT FOUND INTRAOPERATIVELY EXCESSIVE SYNOVITIS, FIBROSIS AND SCARRING. DUE TO THE INTRAOPERATIVE FINDINGS, ONLY AN EXTENSIVE DEBRIDEMENT AND WASHOUT WAS PERFORMED WITHOUT ANY PROSTHESIS EXCHANGE AND/OR PLACEMENT. THE OUTCOME OF THE PATIENT IS UNKNOWN.

  Patient problems: Arthralgia; Fibrosis; Loss of Range of Motion; Synovitis

  MAUDE report 15080364 ↗
• InjuryDec 29, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT, AFTER TKA, PATIENT PRESENTED PAIN. A CT SHOWED HOT SPOTS AND LOOSENING ON TIBIAL COMPONENT AND PATELLA. A TOTAL KNEE REVISION SURGERY WAS PERFORMED TO IMPLANT COMPETITOR'S PRODUCTS. PATIENT OUTCOME UNKNOWN.

  Patient problems: Pain

  MAUDE report 11086802 ↗
• MalfunctionMar 27, 2020Break; Break

  IT WAS REPORTED THAT DURING THE OPERATION OF LEGION KNEE REPLACEMENT, WHEN THE PRODUCT WAS LOADED, A METAL PARTICLE BELONGING TO THE PROSTHESIS WAS SUDDENLY DROPPED FROM THE FRONT SIDE OF THE FEMORAL CONDYLE. IT IS UNNECESSARY TO KNOCK THE METAL PARTICLE AND POSITION DURING SURGERY AND IT WAS NOT BEATEN BY EXTERNAL FORCE. PROCEDURE WAS COMPLETED USING THE ORIGINAL DEVICE.

  Patient problems: No Information

  MAUDE report 9889927 ↗
• InjuryOct 28, 2019Fracture; Fracture

  IT WAS REPORTED THAT A REVISION SURGERY HAD TO BE DONE A FEW DAYS AFTER A TKA BECAUSE THE PATIENT EXPERIENCED A FALL WHICH CAUSED A PERIPROSTHETIC FRACTURE. AFTER THE PROCEDURE PATIENT IS RECOVERING WELL.

  Patient problems: Injury

  MAUDE report 9247442 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K060742, 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
• Z-0591-2015 · Nov 4, 2014 · Terminated
  LEGION(TM) COCR CONSTRAINED FEMORAL COMPONENT, SIZE 6, LEFT, REF 71426006, QTY 1, Smith & Nephew, knee prosthesis Usage:orthopedic.
• Z-0590-2015 · Nov 4, 2014 · Terminated
  LEGION(TM) COCR CONSTRAINED FEMORAL COMPONENT, SIZE 5, RIGHT, REF 71426005, QTY 1, Smith & Nephew, knee prosthesis Usage:orthopedic.
• Z-0589-2015 · Nov 4, 2014 · Terminated
  LEGION(TM) COCR CONSTRAINED FEMORAL COMPONENT, SIZE 4, LEFT, REF 71425004, QTY 1, Smith & Nephew, knee prosthesis Usage:orthopedic.