LEGION 71431175Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 03596010545473), received between May 4, 2021 and Dec 19, 2022 — classified as 3 malfunctions.

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

4 other recalls cover devices cleared under the same FDA submission (K121393); 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 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• MalfunctionDec 19, 2022Separation Failure; Separation Failure

  IT WAS REPORTED THAT, DURING A TKA SURGERY, THE LGN RK HK OFFSET COUPLER TRIAL STD 2MM DEVICE GOT STUCK INTO THE LGN OX CONSTRAIN FEM TRL 5 RT DEVICE. THE PROCEDURE WAS RESUMED, AFTER A SIGNIFICANT DELAY, USING A S+N BACK-UP DEVICE. PATIENT WAS NOT HARMED AS CONSEQUENCE OF THIS PROBLEM. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED. IF ADDITIONAL INFORMATION SHOULD BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED ACCORDINGLY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16008035 ↗
• MalfunctionAug 27, 2021Device Damaged by Another Device; Device Damaged by Another Device

  IT WAS REPORTED THAT A LEGION SCREW-ON DISTAL FEMORAL WEDGE TRIAL 10MM SIZE 5 BROKE OFF FROM A LEGION OXINIUM CONSTRAINED FEMORAL TRIAL SIZE 5 RIGHT. SURGERY WAS COMPLETED WITH A BACKUP DEVICE, WITHOUT ANY DELAY. INSTRUMENTS WERE OUTSIDE THE PATIENT. PATIENT WAS NOT HARMED AS CONSEQUENCE OF THIS PROBLEM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12379139 ↗
• MalfunctionMay 4, 2021Break; Break

  IT WAS REPORTED THAT THE LGN OX CONSTRAIN FEM TRL 5 RT WAS BROKEN. IT IS UNKNOWN IF THE EVENT HAPPENED DURING A SURGICAL PROCEDURE, IF THERE WAS A SURGICAL DELAY, BACKUP DEVICE AVAILABLE OR PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11773187 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K121393. One submission often covers many models, so check the product and lot details in each record.

• Z-0878-2020 · Dec 16, 2019 · Open, Classified
  LEGION AP Cutting Block Size 4, REF 71434409; LEGION AP Cutting Block Size 6, REF 71434411; LEGION AP Cutting Block Size 7, REF 71434412; LEGION AP Cutting Block Size 8, REF 714344
• Z-0200-2019 · Sep 18, 2018 · Terminated
  Smith+Nephew Orthopaedic Division LEGION A/P FEMORAL CUTTING BLOCK, SIZE 6 REF 71434411, QTY: (1) The LEGION AP Femoral Cutting Block is a reusable surgical instrument used to mak
• Z-2163-2018 · May 4, 2018 · Terminated
  smith&nephew GENESIS(R) II TIBIAL Punch, 13 MM, REF 71440408, QTY: (1)
• Z-1902-2018 · Apr 9, 2018 · Terminated
  smith&nephew 5o (5 degree) GENESIS(R) II VALGUS BUSHING, REF CATALOG NUMBER 71440014 The GENESIS II Knee System Components are indicated for rheumatoid arthritis; post-traumatic a