LEGION 71421237Recalls & reported problems

Summary

The FDA's MAUDE database contains 8 adverse event reports that list this exact device (DI 00885556030486), received between May 30, 2017 and Aug 5, 2024 — 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.

• InjuryAug 5, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT, AFTER A TKA WAS PERFORMED ON AN UNKNOWN DATE, THE PATIENT WAS EXPERIENCING PAIN SO THEIR LEGION CR OXIN FEM SZ7 LT WAS REPLACED ON (B)(6) 2024. FURTHER COMPLICATIONS WERE NOT REPORTED. PATIENT'S CURRENT HEALTH STATUS IS UNKNOWN.

  Patient problems: Pain

  MAUDE report 19906896 ↗
• InjuryMay 25, 2023Malposition of Device; Malposition of Device

  IT WAS REPORTED THAT, AFTER A TKA SURGERY DONE ON (B)(6) 2021, THE PATIENT EXPERIENCED A MAL-ALIGNMENT OF THE IMPLANTS. THIS PROBLEM WAS TREATED VIA REVISION SURGERY ON (B)(6) 2023 IN WHICH A LEGION CR OXIN FEM SZ7 LT, A LGN CR HIGH FLEX XLPE SZ 5-6 9MM, AND A GNS II CMT TIB SIZE 6 {} LEFT WERE EXPLANTED AND REPLACED WITH S+N IMPLANTS. NO LASTING INJURY WAS INCURRED TO THE PATIENT TO THIS INCIDENT. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED. IF ADDITIONAL INFORMATION SHOULD BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED ACCORDINGLY.

  Patient problems: Arthralgia; Joint Laxity

  MAUDE report 17007734 ↗
• InjuryNov 11, 2022Inadequacy of Device Shape and/or Size; Adverse Event Without Identified Device or Use Problem; Inadequacy of Device Shape and/or Size; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT, AFTER TKR SURGERY (LEGION CR WITH CORI) HAD BEEN PERFORMED ON EARLY 2022, THE PATIENT COMPLAINED OF INSTABILITY IN LEFT KNEE FROM PRIMARY OPERATION. AFTER ASSESSMENT OF XRAYS, THE SURGEON SUSPECTS THAT THE FEMORAL COMPONENT WAS OVERSIZED. THIS ADVERSE EVENT WAS TREATED BY REVISION SURGERY TO A MORE CONSTRAINED CONSTRUCT. CURRENT HEALTH STATUS OF PATIENT IS UNKNOWN. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED. IF ADDITIONAL INFORMATION SHOULD BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED ACCORDINGLY.

  Patient problems: Joint Laxity

  MAUDE report 15777595 ↗
• InjuryOct 29, 2019Physical Resistance/Sticking; Physical Resistance/Sticking

  IT WAS REPORTED THAT THE PATIENT WAS TREATED DUE TO LEFT KNEE STIFFNESS. THE EVENT WAS RESOLVED VIA MANIPULATION UNDER ANESTHESIA.

  Patient problems: Injury

  MAUDE report 9253231 ↗
• InjuryOct 29, 2019Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED THAT THE PATIENT WAS HOSPITALIZED DUE TO A DEEP VEIN THROMBOSIS. THE EVENT WAS RESOLVED VIA MEDICATION.

  Patient problems: Injury

  MAUDE report 9253227 ↗
• InjuryJun 7, 2018Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available

  IT WAS REPORTED THAT PATIENT HAD A LEGION/GENESIS KNEE IMPLANT ON (B)(6) 2015 AND UNDERWENT A REVISION SURGERY ON (B)(6) 2017 DUE TO INSTABILITY AND LEFT KNEE GIVING AWAY, PAIN, SWELLING, ACCOMPANIED BY WARMTH, ERYTHEMA AND FEVERS.

  Patient problems: Injury

  MAUDE report 7576901 ↗
• InjuryJul 18, 2017Unintended Movement; Unintended Movement

  IT WAS REPORTED THE PATIENT CONTINUED TO HAVE ISSUES FOLLOWING A SURGERY AND ANOTHER PROCEDURE TO REMOVE SCAR TISSUE. SURGEON ASSESSED THE PATIENT¿S LEFT KNEE AS HAVING LOOSE COMPONENTS AND RECOMMENDED SURGERY. A TWO-STEP REVISION SURGERY WAS PERFORMED ON (B)(6) 2010 (EXPLORATORY LEFT KNEE TKA, WITH REMOVAL OF MARKEDLY LOOSE LEGION FEMORAL COMPONENT AND INSERT AND PLACEMENT OF ANTIBIOTIC SPACERS) AND ON (B)(6) 2010 (PLACEMENT OF NEW SN TKA SYSTEM).

  Patient problems: Joint Disorder; Pain

  MAUDE report 6720574 ↗
• InjuryMay 30, 2017Device Operates Differently Than Expected; Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED THAT A REVISION TOOK PLACE DUE TO A FAILED TOTAL KNEE ARTHROPLASTY.

  Patient problems: Failure of Implant; Injury

  MAUDE report 6597602 ↗

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-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-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-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-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.
• 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.