GENESIS II 71440822Recalls & reported problems

Summary

The FDA's MAUDE database contains 16 adverse event reports that list this exact device (DI 03596010407368), received between Dec 21, 2018 and Nov 3, 2025 — classified as 3 injuries, 13 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 16 most recent of 16 reports, in the reporter's own words as published by the FDA.

• MalfunctionNov 3, 2025Fracture; Fracture

  IT WAS REPORTED THAT, DURING A TKA SURGERY, AFTER COMPLETION OF PERFORMING THE FEMORAL CUTS, WHEN REMOVING THE GII POST REF A/P BLK SZ 7 IT WAS REALIZED THAT ONE OF THE PINS HAD BROKEN AND REMAINED IN THE BONE. THIS WAS REMOVED USING PLIERS. THE PROCEDURE WAS PERFORMED, WITHOUT ANY DELAY, USING THE SAME DEVICE. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23460458 ↗
• MalfunctionMar 31, 2025Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT, DURING A TKA SURGERY, WHEN THE GII POST REF A/P BLK SZ 7 WAS PLACED ONTO THE PATIENT'S FEMUR AND TAPPED INTO PLACE, THE BLOCK SHEARED OFF AND FELL TO THE FLOOR, LEAVING THE PINS INSIDE THE PATIENT FEMUR. PINS HAD TO BE REMOVED BEFORE CONSULTANT TO PROCEED TO COMPLETE THE PROCEDURE, CAUSING DELAY TO PATIENT PROCEDURE. THE SURGERY WAS COMPLETED WITH A S+N BACK-UP DEVICE. NO INJURIES WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21731103 ↗
• MalfunctionMar 3, 2025Fracture; Fracture

  IT WAS REPORTED THAT, DURING A TKA SURGERY, ONE OF THE PINS OF THE GII POST REF A/P BLOCK SIZE 7 FRACTURED, WHILE IN USE. THE ITEM WAS REMOVED USING FORCEPS, NO PIECE REMAINED IN PATIENT. THE PROCEDURE WAS RESUMED, AFTER A NON-SIGNIFICANT DELAY, WITH THE SAME DEVICE. PATIENT WAS NOT HARMED AS CONSEQUENCE OF THIS PROBLEM

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21504423 ↗
• MalfunctionOct 24, 2024Fracture; Fracture

  IT WAS REPORTED THAT DURING A TKA SURGERY, A PIN OF THE GII POST REF A/P BLK SZ 7 BROKE WHILE IN USE. THE PIECE WAS REMOVED FROM THE PATIENT WOUND USING A BONE NIBBLER. THE PROCEDURE WAS PERFORMED, AFTER A SIGNIFICANT DELAY DUE TO THE REMOVING OF PIECES, USING THE SAME DEVICE. PATIENT WAS NOT HARMED AS CONSEQUENCE OF THIS PROBLEM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20527572 ↗
• MalfunctionJun 23, 2023Fracture; Fracture

  IT WAS REPORTED THAT DURING SURGERY, THE SPIKE ON THE 4 IN ONE (1) GII POST REF A/P BLK SZ 7 BROKE OFF WHEN REMOVED FROM THE PATIENT'S FEMUR AFTER ALL CUTS WERE MADE. IT HAD TO REMOVE THE SPIKE. THE PROCEDURE WAS PERFORMED, AFTER A NON-SIGNIFICANT DELAY. THE PATIENT WAS NOT INJURED AS A CONSEQUENCE OF THIS PROBLEM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17195867 ↗
• MalfunctionMay 6, 2023Fracture; Fracture

  IT WAS REPORTED THAT, DURING A TKA SURGERY, THE PIN OF A GII POST REF A/P BLK SZ 7 BROKE OFF, BUT IT WAS RETRIEVED. THE SURGERY WAS COMPLETED, WITHOUT ANY DELAY, WITH THE SAME REPORTED DEVICE. NO INJURIES WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16883077 ↗
• MalfunctionFeb 15, 2023Fracture; Fracture

  IT WAS REPORTED THAT, DURING A TKA, THE METAL PART OF A UNIVERSAL PIN DRIVER BECAME DETACHED AND A PIN OF A GII POST REF A/P BLK SZ 7 BROKE OFF. BOTH FAILURES OCCURRED WHILE THE INSTRUMENTS WERE HANDLED IN THE SURGICAL SITE. THE BROKEN PIN OF THE GII POST REF A/P BLK SZ 7 WAS RETRIEVED WITH A PAIR OF FORCEPS AND ACCOUNTED FOR AS BEING COMPLETE. SURGERY WAS RESUMED, WITHOUT ANY DELAY, WITH THE SAME DEVICE. PATIENT WAS NOT HARMED AS CONSEQUENCE OF THIS PROBLEM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16383467 ↗
• MalfunctionApr 9, 2022Break; Break

  IT WAS REPORTED THAT, DURING SET UP OR INSPECTION FOR TKA SURGERY, THE PIN SNAPPED OFF THE BACK OF THE GII POST REF A/P BLK SZ 7. AS THIS HAPPENED BEFORE SURGERY, THERE WAS NOT ANY PATIENT INVOLVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14068276 ↗
• InjuryJun 10, 2021Break; Break

  IT WAS REPORTED THAT, DURING TKA, AFTER DOING THE DISTAL FEMORAL CUTS, THE TWO PEGS ON THE BACK OF THE GII POST REF A/P BLK SZ 7 STAYED ATTACHED TO THE PATIENT'S BONE, ONCE THE BLOCK WAS REMOVED. THE PEGS WERE ABLE TO BE REMOVED USING A BONE NIBBLER. A SURGICAL DELAY OF LESS THAN OR EQUAL TO 30 MINUTES WAS REPORTED. NO OTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11977130 ↗
• InjuryJun 8, 2021Break; Break

  IT WAS REPORTED THAT, DURING A TKA SURGERY, THE PINS OF THE GII POST REF A/P BLK SZ 7 BROKE AND REMAINED IN THE PATIENT¿S FEMUR. THEY WERE REMOVED BY THE SURGEON, WHO USED A GAUGE TO REMOVE THEM. THE PROCEDURE WAS COMPLETED, WITH A DELAY OF 20 MINUTES, USING THE SAME DEVICE. THE PATIENT IS WELL.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11962780 ↗
• InjuryFeb 5, 2021Break; Break

  IT WAS REPORTED THAT ONE OF THE SPIKES BROKE OFF THE BACK OF THE CUTTING BLOCK DURING USE, INSIDE THE PATIENT. THE PROCEDURE FINISHED WITH THE SAME DEVICE. NO SURGICAL DELAY. PATIENT INJURIES WERE NOT REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11284741 ↗
• MalfunctionAug 1, 2020Break; Break

  IT WAS REPORTED THAT THE CUTTING BLOCK BROKE OFF DURING SURGERY, WITH INSTRUMENTS OUTSIDE THE PATIENT. NO INJURY TO PATIENT, NO DELAY IN CASE. A BACKUP SN DEVICE WAS USED TO FINISH THE PROCEDURE. NOTHING FELL INSIDE THE PATIENT. SURGERY OUTCOME WAS GOOD, AND PATIENT LEFT THE OPERATING ROOM IN STABLE CONDITION. 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; No Known Impact Or Consequence To Patient

  MAUDE report 10354126 ↗
• MalfunctionApr 15, 2019Break; Break

  IT WAS REPORTED THAT CUTTING BLOCK SPIKE BROKE OFF WHEN DR. WAS REMOVING THE BLOCK AFTER ONE OF HIS CUTS. EVERYTHING WAS REMOVED FROM THE PATIENT. NO HARM TO THE PATIENT OR STAFF. NO PROCEDURAL DELAYS. A BACKUP DEVICE WAS AVAILABLE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8512727 ↗
• MalfunctionJan 14, 2019Break; Break

  IT WAS REPORTED THAT PEGS BROKE OFF DURING CASE. THE BLOCKS SPIKED FIXATION PIN WAS SUBMERGED IN THE PATIENT SO THEY HAD TO GO IN AND PICK IT OUT. DELAY NO GREATER THAN 30 MINUTES WAS REPORTED. BACKUP DEVICE AVAILABLE.

  Patient problems: No Information; No Known Impact Or Consequence To Patient

  MAUDE report 8243751 ↗
• MalfunctionJan 4, 2019Flaked; Flaked

  IT WAS REPORTED THAT DURING SURGERY WHEN ATTACHING THE SIZE 7 A/P FEMORAL CUTTING BLOCK ONE OF THE PINS BECAME DETACHED FROM THE BACK OF THE CUTTING BLOCK AND HAD TO BE REMOVED FROM THE PATIENT. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITHOUT DELAY USING A BACK-UP DEVICE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8218093 ↗
• MalfunctionDec 21, 2018Break; Break

  IT WAS REPORTED THAT THE CUTTING BLOCK TIES BROKE OFF DURING THE CASE. NO HARM TO PATIENT OR STAFF REPORTED. THERE WAS NO BACKUP AVAILABLE, THE PROCEDURE WAS COMPLETED WITH NO DELAY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8192744 ↗

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