LEGION 71423227Recalls & reported problems

Summary

The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 03596010611505), received between Jun 19, 2019 and Mar 16, 2026 — classified as 5 injuries, 1 malfunction.

The most frequently reported specific device problem is “Expiration Date Error” (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 6 most recent of 6 reports, in the reporter's own words as published by the FDA.

• InjuryMar 16, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT, AFTER A TKA SURGERY THAT HAD BEEN PERFORMED ON (B)(6) 2025, THE PATIENT EXPERIENCED JOINT INFECTION. THIS ADVERSE EVENT WAS TREATED BY A REVISION SURGERY ON (B)(6) 2026, IN WHICH ONE (1) LEGION PS NP FEM SZ 7 LT, ONE (1) LGN PS HIGH FLEX XLPE SZ 7-8 10MM, ONE (1) GNS II CMT TIB SIZE 7 {} LEFT AND ONE (1) GII OVAL RESURFACING PAT 38MM WERE EXPLANTED AND REIMPLANTED WITH ANTIBIOTIC FUNCTIONAL SPACER. CURRENT HEALTH STATUS OF PATIENT IS UNKNOWN.

  Patient problems: Medical device site infection

  MAUDE report 24610751 ↗
• InjuryOct 16, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT PATIENT UNDERWENT A TWO STAGE TKA LEFT REVISION SURGERY IN 2013 DUE TO INFECTION. DURING THE REVISION SURGERY, LEGION/GII SMITH & NEPHEW COMPONENT(S) WERE IMPLANTED. 1.47 YEARS AFTER THIS PROCEDURE, THE PATIENT SUSTAINED AN INFECTION THAT REQUIRED A 2 STAGE TKA RE-REVISION. IT IS UNKNOWN WHICH DEVICES WERE EXPLANTED/EXCHANGED DURING THIS PROCEDURE. THIS INFORMATION WAS COLLECTED RETROSPECTIVELY AS PART OF A POST-MARKET CLINICAL FOLLOW UP ACTIVITY AND IS PROVIDED IN AN ANONYMIZED FORMAT; THEREFORE, NO FURTHER INFORMATION AVAILABLE.

  Patient problems: Insufficient Information

  MAUDE report 20467311 ↗
• InjuryFeb 23, 2023Adverse 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) 2016 AND A WASHOUT AND LINER EXCHANGE HAD BEEN PERFORMED 2 WEEKS AFTER. A REVISION SURGERY WAS PERFORMED ON (B)(6) 2023 BECAUSE THE PATIENT PRESENTED AN INFECTION. THIS WAS A FIRST STAGE REVISION. NO DEVICES HAVE BEEN IMPLANTED, OTHER THAN A SPACER K. NO FURTHER INFORMATION AVAILABLE AT THIS MOMENT.

  Patient problems: Unspecified Infection

  MAUDE report 16432145 ↗
• InjuryApr 19, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  "US LEGAL" IT WAS REPORTED THAT, APPROXIMATELY 2 YEARS AFTER THE PRIMARY IMPLANTATION SURGERY PERFORMED ON (B)(6) 2018, THE PATIENT UNDERWENT A KNEE REVISION SURGERY DUE TO UNSPECIFIED REASONS. DURING THE REVISION SURGERY, THE UPPER PORTION FROM THE SYSTEM WAS EXPLANTED AND REPLACED WITH OTHER PRODUCTS FROM SMITH & NEPHEW. THE PATIENT COULD NOT SPECIFY WHICH COMPONENTS WERE EXPLANTED FROM THE REVISION. THE PATIENT KEPT EXPIRING ISSUES.

  Patient problems: Failure of Implant

  MAUDE report 14153782 ↗
• MalfunctionApr 29, 2020Expiration Date Error; Expiration Date Error

  IT WAS REPORTED THAT THE DEVICE WAS CONTAINED IN A PACKAGE WITH EXPIRATION TIME FOR 2025. WHEN SCANNING, THE IMPLANT ITEM WAS FOUND TO BE MARKED AS EXPIRED ON THE SYSTEM SINCE 2016. NO CASE RELATED. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED. IF ADDITIONAL INFORMATION SHOULD BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED ACCORDINGLY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10012387 ↗
• InjuryJun 19, 2019Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED THAT PROSTHESIS WAS REMOVED DUE TO INFECTION BEING CLEARED UP IN A SECOND STAGE REVISION SURGERY. FIRST STAGE SURGERY WAS PURELY TO TREAT INFECTION AND NO COMPONENTS WHERE REMOVED UNTIL SECOND STAGE.

  Patient problems: Unspecified Infection

  MAUDE report 8712941 ↗

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-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.
• 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.