LEGION 71933570Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00885556062128), received between Oct 18, 2017 and Oct 18, 2017 — classified as 2 injuries.

The most frequently reported specific device problem is “Osseointegration Problem” (1 report).

7 other recalls cover devices cleared under the same FDA submission (K043440); 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 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• InjuryOct 18, 2017Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT PATIENT WAS TREATED WITH ANTIBIOTIC THERAPY (KEFLEX 500MG AND BACTRIM 800 MG PER OS THEN VANCOMYCIN 2000MG IV ON (B)(6) 2014) DUE TO CELLULITIS LEFT LOWER EXTREMITY.

  Patient problems: Cellulitis

  MAUDE report 6957422 ↗
• InjuryOct 18, 2017Osseointegration Problem; Osseointegration Problem

  IT WAS REPORTED THAT PATIENT UNDERWENT A TOTAL KNEE REVISION SURGERY DUE TO ASEPTIC LOOSENING OF LEFT TOTAL KNEE ARTHROPLASTY. PATIENT DEVELOPED INCREASING PAIN, AND BECAME INTOLERABLE. LOOSENING OF DEVICE (TIBIAL BASEPLATE) SHOWN ON BONE SCAN. THE FEMUR WAS WELL FIXED , BUT BECAUSE OF A DESIRE TO LOWER THE JOINT LINE AND IMPROVE THE SITUATION, THE FEMORAL COMPONENT WAS REMOVED.

  Patient problems: Failure of Implant

  MAUDE report 6957327 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K043440. 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-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
• 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.