LEGION 71423225Recalls & reported problems

Summary

The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 03596010607607), received between Sep 30, 2018 and Nov 27, 2024 — classified as 6 injuries.

The most frequently reported specific device problem is “Insufficient Device Problem Information” (2 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 16, 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.

• InjuryNov 27, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT PATIENT UNDERWENT A TKA LEFT REVISION SURGERY IN 2021 DUE TO AN INFECTION. DURING THE REVISION SURGERY, LEGION/GII SMITH & NEPHEW COMPONENT(S) WERE IMPLANTED. 0,51 YEARS AFTER THIS PROCEDURE, THE PATIENT SUSTAINED ANOTHER INFECTION AND REQUIRED A 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: Medical device site infection

  MAUDE report 20790292 ↗
• InjurySep 22, 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) 2020, THE PATIENT EXPERIENCED STIFFNESS, PAIN, AND SUSPECTED FEMORAL LOOSENING DUE TO RADIOLUCENT LINES ON X-RAY. A REVISION SURGERY WAS PERFORMED ON (B)(6) 2023 TO ADDRESS THIS ADVERSE EVENT. FEMORAL COMPONENT, TIBIAL INSERT, AND TIBIAL BASEPLATE WERE REMOVED. STRYKER HINGE PROSTHESIS WAS IMPLANTED. PATIENT IS RECOVERING WELL AND HAS GONE HOME.

  Patient problems: Loss of Range of Motion; Pain; Radiolucent Lines

  MAUDE report 17799417 ↗
• InjuryNov 29, 2022Adverse 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 2015, THE PATIENT EXPERIENCED AN ASEPTIC LOOSENING RIGHT TOTAL KNEE PROSTHESIS. THIS ADVERSE EVENT WAS TREATED BY A REVISION SURGERY ON (B)(6) 2022, ALL IMPLANTS (LEGION PS NP FEM SZ 5 LT, LGN REV TIBIA BASE SZ 3 RT, LGN PRESSFIT STEM 14MM X 160MM, LEGION CON ART INS 9MM SZ 3-4, LGN PRESSFIT STEM 16MM X 160MM, LGN OFFSET COUPLER 4MM) WERE EXCHANGED. PATIENT'S CURRENT HEALTH STATUS IS UNKNOWN. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED. IF ADDITIONAL INFORMATION SHOULD BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED ACCORDINGLY.

  Patient problems: Inadequate Osseointegration

  MAUDE report 15875768 ↗
• InjuryOct 1, 2021Adverse 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) 2021, THE PATIENT EXPERIENCED REDNESS, SWELLING, HEAT, PAIN AND LIMITED MOVEMENT IN THE LEFT KNEE JOINT. IT WAS TRIED TO TREAT THIS ADVERSE EVENT WITH ANTI-INFLAMMATORY MEDICATION BUT IT WAS NOT SOLVED. ON (B)(6) 2021 A CULTURE WITH JOINT FLUID AND ANTIBIOTIC TREATMENT (VANCOMYCIN + MEROPENEM) WAS PERFORMED, THIS LED TO A REVISION SURGERY ON (B)(6) 2021 IN WHICH THE JOINT WAS CLEANED AND THE LEGION PS NP FEM SZ 5 LT WAS REPLACED. AFTER THAT, ANTIBIOTIC INJECTION IN ARTICULAR CAVITY AND SYSTEMIC INTRAVENOUS ANTIBIOTIC TREATMENT WERE GIVEN. THE CURRENT HEALTH STATUS OF THE PATIENT IS UNKNOWN.

  Patient problems: Bacterial Infection; Erythema; Inflammation; Loss of Range of Motion; Unspecified Infection

  MAUDE report 12560962 ↗
• InjuryOct 9, 2018Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED THAT A MANIPULATION UNDER ANESTHESIA WAS PERFORMED 4 MONTHS AFTER THE PRIMARY SURGERY.

  Patient problems: Injury

  MAUDE report 7950193 ↗
• InjurySep 30, 2018Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED THAT A REVISION SURGERY HAS BEEN PERFORMED DUE TO A SEPTIC ARTHRITIS DEVELOPMENT. AN INCISION AND DRAINAGE WITH IRRIGATION AND DEBRIDEMENT WAS PERFORMED ON THE LEFT KNEE.

  Patient problems: Injury

  MAUDE report 7921367 ↗

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-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.
• 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.