LEGION 71423238Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 00885556031391), received between Jul 31, 2018 and Mar 20, 2026 — classified as 4 injuries.

The most frequently reported specific device problem is “Insufficient Device Problem Information” (3 reports).

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 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• InjuryMar 20, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT, AFTER A TKA WAS PERFORMED ON AN UNKNOWN DATE, THE PATIENT EXPERIENCED AN INFECTION. ON THE (B)(6) 2025, A FUNCTIONAL SPACER WAS PLACED. ONCE THE INFECTION WAS TAKEN CARE OF, HINGE IMPLANTS WERE PLACED ON THE (B)(6) 2026. THE CURRENT HEALTH STATUS OF THE PATIENT IS UNKNOWN.

  Patient problems: Medical device site infection

  MAUDE report 24650739 ↗
• InjuryOct 25, 2024Adverse Event Without Identified Device or Use Problem; Insufficient Device Problem Information; Adverse Event Without Identified Device or Use Problem; Insufficient Device Problem Information

  IT WAS REPORTED THAT PATIENT UNDERWENT A TKA RIGHT REVISION SURGERY IN 2015 DUE TO AN INFECTION. DURING THE REVISION SURGERY, LEGION/GII SMITH & NEPHEW COMPONENT(S) WERE IMPLANTED. 0.44 YEARS AFTER THIS PROCEDURE, THE PATIENT SUSTAINED ANOTHER INFECTION THAT REQUIRED A TKA RE-REVISION. DURING THIS PROCEDURE AN UNKNOWN TIBIAL COMPONENT, THE GENESIS II DISHED TIBIAL INSERT, AND THE GENESIS II SPC FEMORAL COMPONENT WERE REVISED. 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; Unspecified Infection

  MAUDE report 20535916 ↗
• InjuryFeb 26, 2019Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED THAT REVISION SURGERY WAS PERFORMED DUE TO SEPSIS PRESENT. ALL IMPLANTS WERE REMOVED. ALSO, A WASHOUT WAS DONE AND A CEMENT SPACER WAS INSERTED.

  Patient problems: Unspecified Infection

  MAUDE report 8371864 ↗
• InjuryJul 31, 2018Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED A SERIOUS INJURY IN WHICH FEMORAL COMPONENT WAS REVISED DUE TO INFECTION. IT WAS REVISED TO A LEGION CONSTRAINED FEMORAL.

  Patient problems: Post Operative Wound Infection

  MAUDE report 7737242 ↗

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.