LEGION 71421208Recalls & reported problems

Summary

The FDA's MAUDE database contains 7 adverse event reports that list this exact device (DI 00885556029701), received between Oct 1, 2018 and Nov 9, 2021 — classified as 6 injuries, 1 malfunction.

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 7 most recent of 7 reports, in the reporter's own words as published by the FDA.

• InjuryNov 9, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT, AFTER TOTAL KNEE ARTHROPLASTY WAS CONDUCTED ON (B)(6) 2018, THE PATIENT EXPERIENCED PAIN ON AND AROUND THE KNEE. X-RAYS SHOW LOOSENING OF IMPLANTS AND A SEPARATION/DETERIORATION BETWEEN CEMENT AND BONE. REVISION SURGERY WAS RECOMMENDED BY SURGEON, WHICH IS STILL TO BE SCHEDULED. CURRENT PATIENT'S HEALTH STATUS IS UNKNOWN.

  Patient problems: Failure of Implant; Pain

  MAUDE report 12779810 ↗
• InjuryJul 2, 2020Defective Device; Insufficient Device Problem Information; Defective Device; Insufficient Device Problem Information

  IT WAS REPORTED THAT A REVISION SURGERY HAD TO BE PERFORMED DUE TO TIBIAL LOOSENING. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED. IF ADDITIONAL INFORMATION SHOULD BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED ACCORDINGLY.

  Patient problems: Failure of Implant; Inadequate Osseointegration; Injury; Joint Laxity

  MAUDE report 10224289 ↗
• InjuryApr 4, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A REVISION SURGERY WAS PERFORMED DUE TO INFECTION.

  Patient problems: Unspecified Infection

  MAUDE report 9926199 ↗
• MalfunctionJan 27, 2020Connection Problem; Connection Problem

  IT WAS REPORTED THAT DURING SURGERY THE SURGEON STATES THAT THE POST WEDGE WOULD NOT SCREW TIGHT ENOUGH ON THE FEMUR. THE SURGEON HAD TO CEMENT WEDGE INTO PLACE. NO DELAY TO PROCEDURE, NO INJURY TO PATIENT. S&N BACKUP WAS AVAILABLE BUT NOT USED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9632602 ↗
• InjuryDec 16, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT STATUS POST RIGHT TOTAL KNEE ARTHROPLASTY, PATIENT WAS RE-ADMITTED TO THE HOSPITAL DUE TO UNCONTROLLED PAIN AND POSSIBLE ACUTE INFECTION. PATIENT HAD BASELINE RIGHT THIGH PAIN RADIATING FROM HIS BACK, BUT REPORTS THAT PAIN HAD GOTTEN A BIT WORSE AFTER SURGERY. PATIENT RECEIVED AN MRI. TOLERATING PO. PAIN WAS CONTROLLED WITH MORPHINE SR. PATIENT WAS FEBRILE (99.6) HAD A SWOLLEN AND PAINFUL KNEE. HE WAS ADMITTED FOR FEBRILE WORKUP, OBSERVATION AND POSSIBLE WASHOUT.

  Patient problems: Pain; Unspecified Infection

  MAUDE report 8167851 ↗
• InjuryDec 6, 2018Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED THAT A REVISION SURGERY WAS PERFORMED IN THE PATIENT DUE TO PAIN AND SWELLING. NO DELAY REPORTED. IMPLANTS REPLACED WITH COMPETITOR DEVICES.

  Patient problems: Injury

  MAUDE report 8138020 ↗
• InjuryOct 1, 2018Loss of Osseointegration; Loss of Osseointegration

  IT WAS REPORTED THAT THE PATIENT (B)(6) WAS DIAGNOSED WITH LOOSENING OF RIGHT TOTAL KNEE ARTHROPLASTY AFTER TKA IN 2012 AND POST RESURFACING OF THE PATELLA PLUS INCREASE IN THE THICKNESS OF THE POLY INSERT TO 13MM IN 2014. A REVISION SURGERY WAS PERFORMED AND THE TIBIAL BASEPLATE, FEMORAL COMPONENT AND THE POLY INSERT WERE REPLACED.

  Patient problems: Injury

  MAUDE report 7921500 ↗

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-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.