LEGION 71421225Recalls & reported problems

Summary

The FDA's MAUDE database contains 8 adverse event reports that list this exact device (DI 00885556030424), received between Aug 11, 2017 and Dec 27, 2023 — classified as 8 injuries.

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

8 other recalls cover devices cleared under the same FDA submission (K043440, K093746, 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 8 most recent of 8 reports, in the reporter's own words as published by the FDA.

• InjuryDec 27, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT, DUE TO RIGHT KNEE ADVANCED ARTHRITIS WITH SEVERE DEFORMITY, TKA WAS PERFORMED ON (B)(6) 2023 IN WHICH A LEGION OX CRUCIATE RETAINING FEMORAL COMPONENT WAS IMPLANTED. THE PATIENT HAS ATTENDED PHYSICAL THERAPY AFTER SURGERY, BUT SINCE THEN HAS HAD CHRONIC SWELLING AND PAIN. DURING A FOLLOW-UP ON 15-SEPT-2023 THEY WERE DIAGNOSED WITH DECREASED RANGE OF MOTION AND ARTHROFIBROSIS. A RIGHT KNEE MANIPULATION UNDER ANESTHESIA WAS CONDUCTED ON (B)(6) 2023 TO TREAT THIS, IN WHICH FULL EXTENSION OF THE KNEE WAS OBTAINED. PATIENT HAS ALSO BEEN GIVEN EXERCISES AND MEDICATION TO OBTAIN FULL EXTENSION. IN OCTOBER-2023, DAYTIME GABAPENTIN WAS PRESCRIBED AND AN ADDITIONAL 3-6 MONTHS OF CLOSE FOLLOW-UP WAS DISCUSSED. ON 02-NOV-2023 AN X-RAY SHOWED STABLE ARTHROPLASTY COMPONENTS WITH NO EVIDENCE OF FRACTURE OR OSTEOLYSIS. FURTHER COMPLICATIONS HAVE NOT BEEN REPORTED.

  Patient problems: Fibrosis; Loss of Range of Motion; Pain; Swelling/ Edema

  MAUDE report 18399099 ↗
• InjuryNov 16, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A PATIENT RECEIVED MANIPULATION UNDER ANESTHESIA DUE TO STIFFNESS AFTER A RIGHT TOTAL KNEE. THE OUTCOME IS RESOLVED. NO ADDITIONAL INFORMATION WAS PROVIDED AT THIS TIME. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED. IF ADDITIONAL INFORMATION SHOULD BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED ACCORDINGLY.

  Patient problems: Failure of Implant

  MAUDE report 10846771 ↗
• InjuryOct 18, 2019Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED THAT AFTER SURGERY THE PATIENT APPARENTLY SHOWS SOME ALLERGIC REACTION TO THE SYSTEM IMPLANTED.

  Patient problems: Hypersensitivity/Allergic reaction

  MAUDE report 9211443 ↗
• InjurySep 13, 2019Physical Resistance/Sticking; Physical Resistance/Sticking

  IT WAS REPORTED THAT PATIENT HAD STIFFNESS AND ARTHROFIBROSIS, AND MANIPULATION UNDER ANESTHESIA WAS PERFORMED TO RESOLVE THE EVENT.

  Patient problems: Injury

  MAUDE report 9050851 ↗
• InjuryDec 28, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT STARTED WITH ERYTHEMA SWELLING SUPRAPATELLAR AREA FOR 2 WEEKS. SHE WAS COMPLAINED OF PAIN DUE TO CELLULITIS. THE PATIENT HAD PAIN STIFFNESS AND FAILED POST ATTEMPTS AND MANIPULATION OF THE RIGHT KNEE. SHE WAS ADMITTED FOR IV VANCOMYCIN ADMINISTRATION FOR SUSPECTED DEEP JOINT PROSTHETIC INFECTION.

  Patient problems: Injury; Unspecified Infection

  MAUDE report 8205232 ↗
• InjuryDec 28, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A RIGHT KNEE CLOSED MANIPULATION UNDER ANESTHESIA WAS PERFORMED TO THE PATIENT DUE TO ARTHROFIBROSIS, STATUS POST TOTAL KNEE ARTHROPLASTY.

  Patient problems: Fibrosis; Injury

  MAUDE report 8205231 ↗
• InjuryMay 14, 2018Loose or Intermittent Connection; Loose or Intermittent Connection

  IT WAS REPORTED THAT A SURGICAL INTERVENTION WAS PERFORMED DUE TO KNEE INSTABILITY.

  Patient problems: No Information

  MAUDE report 7511027 ↗
• InjuryAug 11, 2017Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED THAT REVISION SURGERY WAS PERFORMED DUE TO INSTABILITY.

  Patient problems: Failure of Implant; Injury; Joint Dislocation

  MAUDE report 6788696 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K043440, K093746, K230653. One submission often covers many models, so check the product and lot details in each record.

• Z-0278-2025 · Oct 2, 2024 · Open, Classified
  smith&nephew LEIGON OXINIUM CONSTRAINED NONPOROUS FEMORAL COMPONENT, SIZE 4 LEFT, REF 71421164; PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL/POL
• Z-0277-2025 · Oct 2, 2024 · Open, Classified
  smith&nephew LEIGON OXINIUM CONSTRAINED NONPOROUS FEMORAL COMPONENT, SIZE 3 LEFT, REF 71421163; PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL/POL
• 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-1951-2021 · May 19, 2021 · Terminated
  LEGION Posterior Stabilized OXINIUM Femoral Component, REF 71421216, Size 6, Left, Nonporous Femoral Component, A/P 65.5 MM, M/L 73 MM, For Cemented Use Only, ZR-2.5NB,Sterile. Kn
• Z-2538-2019 · Jan 15, 2018 · Completed
  LEGION(TM) HEMI STEP TIBIAL WEDGE RK/HK, 5 MM, SIZE 3-4 LT.MDL/RT-LAT, REF 71423432 Product Usage: The constrained knee systems are designed for use in patients in primary and r
• Z-0816-2016 · Jan 18, 2016 · Terminated
  LEGION(TM) HEMI STEPPED, TIBIAL SCREW-ON WEDGE, REF 71421147, QTY 1, 5 MM, SIZE 5-6 LT-LAT / RT-MDL; Tibial knee prosthesis, augment.
• Z-1820-2009 · Jan 22, 2009 · Terminated
  LEGION Pressfit Stem, Straight, 20 MM X 160 MM, REF 71424053, Sterile, Smith & Nephew, Memphis TX 38116. The device is used for Orthopedic Knee Implants.
• Z-1819-2009 · Jan 22, 2009 · Terminated
  LEGION Pressfit Stem, Straight, 10 MM X 160 MM, REF 71424043, Sterile, Smith & Nephew, Memphis TX 38116. The device is used for Orthopedic Knee Implants.