LEGION 71434331Recalls & reported problems

Summary

The FDA's MAUDE database contains 11 adverse event reports that list this exact device (DI 03596010549815), received between Aug 21, 2020 and Nov 14, 2024 — classified as 11 malfunctions.

The most frequently reported specific device problem is “Break” (6 reports).

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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 11 most recent of 11 reports, in the reporter's own words as published by the FDA.

• MalfunctionNov 14, 2024Separation Failure; Separation Failure

  IT WAS REPORTED THAT, DURING A TKA SURGERY, A PIN GOT STUCK IN ONE (1) LGN TIBIAL CUTTING BLOCK LEFT, WELDING ITSELF TOGETHER. THE ISSUE OCCURRED DURING USE IN PATIENT, AND THEY WERE UNABLE TO REMOVE THE PIN. AFTER FREEING THE BLOCK FROM THE PATIENT, THE PIN WAS CUT OFF AND THE PROCEDURE WAS COMPLETED, AFTER A DELAY OF MORE THAN 30 MINUTES, WITH THE SAME DEVICE. NO INJURY WAS REPORTED AS A CONSEQUENCE OF THIS ISSUE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20684244 ↗
• MalfunctionOct 6, 2023Break; Break

  IT WAS REPORTED THAT, DURING A TKA SURGERY, THE 65 MM SPEED PIN OF A LGN TIBIAL CUTTING BLOCK LEFT BROKE OFF IN THE CROSS PIN HOLE. THE PROCEDURE WAS RESUMED, AFTER A NON-SIGNIFICANT DELAY, WITH THE SAME DEVICE. NO INJURY WAS REPORTED AS A CONSEQUENCE OF THIS ISSUE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17887166 ↗
• MalfunctionDec 10, 2021Break; Break

  IT WAS REPORTED THAT, THE LGN TIBIAL CUTTING BLOCK LEFT WAS BROKEN. IT IS UNKNOWN WHETHER THE EVENT HAPPENED DURING SURGERY AND IF THERE WAS PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12979891 ↗
• MalfunctionJun 30, 2021Physical Resistance/Sticking; Physical Resistance/Sticking

  IT WAS REPORTED THAT, THE PINS OF A LGN TIBIAL CUTTING BLOCK LEFT WERE STUCK. IT IS UNKNOWN WHETHER THE EVENT HAPPENED DURING SURGERY AND IF THERE WAS A PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12097446 ↗
• MalfunctionMay 20, 2021Break; Break

  IT WAS REPORTED THAT DURING A TKA, THE THUMBSCREW OF A LEGION TIBIAL CUTTING BLOCK LEFT BROKE OFF (OUTSIDE THE PATIENT). THERE WAS NO SIGNIFICANT DELAY AND THE PROCEDURE WAS FINISHED USING A SMITH & NEPHEW BACK UP. PATIENT WAS NOT HARMED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11860161 ↗
• MalfunctionApr 2, 2021Mechanical Jam; Mechanical Jam

  IT WAS REPORTED THAT THE PINS ARE STUCK IN THE CUTTING BLOCK. IT IS UNKNOWN WHEN THE EVENT OCCURRED. NO PATIENT INVOLVEMENT HAS BEEN REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11610605 ↗
• MalfunctionMar 4, 2021Break; Break

  IT WAS REPORTED THAT, DURING A TKA PROCEDURE A LGN TIBIAL CUTTING BLOCK LEFT WAS FOUND TO BE BROKEN. IT IS UNKNOWN WHETHER THE EVENT HAPPENED DURING SURGERY AND IF THERE WAS PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11408834 ↗
• MalfunctionFeb 28, 2021Break; Break

  IT WAS REPORTED THAT DURING A TKA, IT WAS NOTICED THAT THERE WERE BURRS AROUND THE PINS OF THE LEGION TIBIAL CUTTING BLOCK LEFT CAUSING PINS TO BIND WHILE INSIDE THE PATIENT. THE SURGERY WAS COMPLETED WITHOUT DELAYS USING THE SAME DEVICE. THERE WAS NO REPORT OF INJURIES. 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 11391024 ↗
• MalfunctionDec 31, 2020Mechanical Jam; Mechanical Jam

  IT WAS REPORTED DURING THE TKA PROCEDURE THAT THE PIN WAS STUCK IN ONE OF THE HOLES. THE INCIDENT OCCURRED INSIDE THE PATIENT. THE PROCEDURE WAS COMPLETED WITHOUT DELAY, USING A BACKUP FROM SMITH & NEPHEW. NO PATIENT INJURY OR OTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11103191 ↗
• MalfunctionOct 20, 2020Mechanical Problem; Mechanical Jam; Mechanical Problem; Mechanical Jam

  IT WAS REPORTED THAT DURING SURGERY, SPEED PIN COLD WELDED INTO CUTTING BLOCK. PROCEDURE CONTINUED WITH A BACKUP DEVICE FROM SMITH AND NEPHEW, WITHOUT A DELAY OR AN INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions; No Consequences Or Impact To Patient

  MAUDE report 10708907 ↗
• MalfunctionAug 21, 2020Break; Break

  IT WAS REPORTED THAT DURING SURGERY THE KNOB ON THE LGN TIBIAL CUTTING BLOCK LEFT ((B)(4)) BROKE OFF AND IS NOW LOCKED ON TO GII NON SPIKE-FIXATION ROD ((B)(4)). DEVICE BROKE OUTSIDE AND ALL PIECES WERE RECOVERED, NOTHING FELL INSIDE THE PATIENT. A DELAY OF LESS THAN 30 MIN WAS REPORTED. S&N BACK UP DEVICE WAS USED TO COMPLETE THE PROCEDURE.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 10437657 ↗

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