LEGION 71434409Recalls & reported problems

Summary

The FDA's MAUDE database contains 13 adverse event reports that list this exact device (DI 03596010549174), received between Jul 15, 2018 and May 2, 2024 — classified as 2 injuries, 11 malfunctions.

The most frequently reported specific device problem is “Break” (8 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 13 most recent of 13 reports, in the reporter's own words as published by the FDA.

• MalfunctionMay 2, 2024Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT DURING A TKA SURGERY, THE SCREWS OF THE LGN AP FEM CUTTING BLK SZ 4 FELL OUT OF THE DEVICE. THE PROCEDURE WAS RESUMED, WITHOUT ANY DELAY, USING A S+N BACK-UP DEVICE. PATIENT WAS NOT HARMED AS CONSEQUENCE OF THIS PROBLEM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19235650 ↗
• MalfunctionJan 22, 2024Detachment of Device or Device Component; Detachment of Device or Device Component

  IT HAS BEEN REPORTED THAT, DURING A TKA, THE LGN AP FEM CUTTING BLK SZ 4'S CHIA BALL WAS FALLING OUT. PREVENTING THE DEVICE FROM USE IT. SURGERY WAS PERFORMED, WITHOUT ANY DELAY, WITH THE SAME DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18553445 ↗
• MalfunctionDec 20, 2022Fracture; Fracture

  IT WAS REPORTED THAT, DURING A REVISION SURGERY, THE LGN AP FEM CUTTING BLK SZ 4 BROKE INTO 2 WHILE REAMING FOR THE OFFSET. THE PROCEDURE WAS RESUMED, AFTER A NON-SIGNIFICANT DELAY (10 MINUTES), WITH A CHANGE IN SURGICAL TECHNIQUE. PATIENT WAS NOT INJURED 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 16019314 ↗
• MalfunctionDec 19, 2022Break; Degraded; Break; Degraded

  IT WAS REPORTED THAT, DURING A TKA, A LGN AP FEM CUTTING BLK SZ 4 BROKE AND IT WAS NOTICED TO PRESENT WEAR AND TEAR. THE SURGERY WAS COMPLETED, WITHOUT ANY DELAY, WITH THE SAME REPORTED DEVICE. NO INJURIES WERE REPORTED. 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 16011190 ↗
• MalfunctionJun 8, 2022Fracture; Fracture

  IT WAS REPORTED THAT, DURING TKA SURGERY, WHILE HAMMERING THE PINS WITH AN LGN AP FEM CUTTING BLK SZ 4, IT WAS NOTICED THAT THE BLOCK WAS BROKEN INTO TWO PIECES. NO PIECES FELL INSIDE THE PATIENT. THE PROCEDURE WAS COMPLETED WITHOUT DELAY USING AN S+N BACKUP DEVICE. THE PATIENT WAS NOT HARMED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14638701 ↗
• MalfunctionMar 15, 2022Fracture; Fracture

  IT WAS REPORTED THAT A LEGION FEMORAL CUTTING BLOCK SIZE 4 BROKE IN TO TWO PIECES. AS THIS HAPPENED AFTER SURGERY, THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13776600 ↗
• MalfunctionJul 8, 2021Break; Break

  IT WAS REPORTED THAT, DURING FIELD INSPECTION, THE LGN AP FEM CUTTING BLK SZ 4 CUT GUIDE WAS BROKEN, AND FIVE (5) DISTAL CUT BLOCKS, FROM 4.5 MM TO 8.5 MM, WERE RUSTED. AS THIS WAS NOTICED UPON FIELD INSPECTION, THERE WAS NOT PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12136027 ↗
• InjuryJan 5, 2021Break; Break

  IT WAS REPORTED THAT, DURING A TKA SURGERY, FEMORAL CUTTING BLOCK BROKE DURING CASE. THE DEVICE BROKE DURING SURGERY, WHILE INSIDE THE PATIENT. IT IS UNKNOWN IF PIECES FELL INTO THE PATIENT. THE PROCEDURE WAS COMPLETED WITHOUT DELAY WITH A COMPETITOR DEVICE. NO OTHER COMPLICATIONS WERE REPORTED. 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 11119313 ↗
• MalfunctionDec 30, 2020Break; Break

  IT WAS REPORTED THAT THE INSTRUMENT WAS FOUND INSIDE THE TRAY BROKEN IN HALF. NO PATIENT INVOLVED IN THE CASE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11094838 ↗
• InjuryMay 26, 2020Break; Break

  IT WAS REPORTED THAT DURING SURGERY THE BLOCK BROKE APART WHILE THE SURGEON WAS CUTTING THROUGH IT. PROCEDURE WAS COMPLETED WITH A SMITH & NEPHEW DEVICE SIZE 5.

  Patient problems: Injury

  MAUDE report 10089818 ↗
• MalfunctionDec 22, 2019Break; Break

  IT WAS REPORTED THAT DURING A KNEE REVISION, THE VERY LAST CUT OF THE FEMUR ANTERIOR CHAMFER, THE CUTTING BLOCK FAILED INTO TWO DISTINCT PIECES. EVERYTHING WAS REMOVED AND SURGERY ENDED UP WITHOUT ANY DELAY. THE SURGEON WAS ABLE TO FINISH THE LAST CUT FREEHAND.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9508600 ↗
• MalfunctionDec 27, 2018Break; Break

  IT WAS REPORTED THAT DURING SURGERY THE BALL BEARINGS THAT HOLD THE VALVES COLLETT IN PLACE CAME LOOSE. DEVICE BROKE IN PATIENT, ALL PIECES ACCOUNTED FOR. NO DELAY OR INJURY REPORTED. NO BACK UP REQUIRED, DEVICE USE HAD BEEN COMPLETED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8201038 ↗
• MalfunctionJul 15, 2018Break; Break

  IT WAS REPORTED THAT WHILE EVISING A ZIMMER UNI KNEE TO A S&N LEGION REVISION KNEE, CUTTING BLOCK SHEARED IN HALF WHILE TRYING TO MAKE CHAMPHER CUTS. DOCTOR HAD TO "FREE HAND" CUT THE FEMUR.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7688847 ↗

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