LEGION 71434308Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 03596010549679), received between Jul 20, 2020 and Oct 9, 2023 — classified as 1 injury, 2 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.

• MalfunctionOct 9, 2023Fracture; Fracture

  IT WAS REPORTED THAT DURING A TKA A LGN COUNTERBORE REAMER BROKE IN TWO PARTS DURING REAMING. THE PROCEDURE WAS RESUMED, WITHOUT ANY DELAY, USING THE SAME DEVICE. IT IS UNKNOWN IF ANY PIECE FELL IN TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17895462 ↗
• MalfunctionMar 18, 2021Break; Break

  IT WAS REPORTED THAT DURING INSPECTION PROCESS, IT WAS NOTICED THAT THE LGN COUNTERBORE REAMER IS CHIPPED AND HAD LOST THE ABILITY TO REAM BONE PROPERLY. THERE WAS NO CASE INVOLVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11515545 ↗
• InjuryJul 20, 2020Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED THAT ON TKA DUE TO UNSPECIFIED FUNCTIONAL FAILURE, THE SURGEON SHIFTED FROM USING AN OFFSET DUE TO ¿SUB OPTIMAL¿ BONE REMOVAL. THE PROCEDURE WAS FINISHED IN A CHANGE OF SURGICAL TECHNIQUE. NO DELAY. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED. IF ADDITIONAL INFORMATION SHOULD BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED ACCORDINGLY.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 10299994 ↗

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