GENESIS II 71440467Recalls & reported problems

Summary

The FDA's MAUDE database contains 10 adverse event reports that list this exact device (DI 03596010443076), received between Mar 23, 2018 and Aug 4, 2025 — classified as 2 injuries, 8 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. What reports can and can't tell you · How this data works · Data updated Oct 16, 2026.

Most reported problems

Recent adverse event reports

The 10 most recent of 10 reports, in the reporter's own words as published by the FDA.

• MalfunctionAug 4, 2025Fracture; Fracture

  IT WAS REPORTED THAT DURING A TOTAL KNEE ARTHROPLASTY, ONE GII PRIM P/S COLLET W/THMBSCRW BROKE DURING REAMING. THE PIECES FELL INTO THE PATIENT AND WERE RETRIEVED USING TWEEZERS. THE PROCEDURE WAS RESUMED WITHOUT ANY SURGICAL DELAY USING THE SAME DEVICE. NO INJURY WAS REPORTED AS A CONSEQUENCE OF THIS ISSUE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22710325 ↗
• MalfunctionApr 10, 2025Fracture; Fracture

  IT WAS REPORTED THAT, DURING A TKA SURGERY, WHEN THE SPECIALIST WANTED TO SEAT THE PIECE IN THE BONE, THE GOLDEN SCREW OF ONE (1) GII PRIM P/S COLLET W/THMBSCRW BROKE AFTER THE SURGEON IMPACTED IT WITH THE HAMMER. THE METAL FRAME WAS HOLD WITH BARE HANDS TO FINISH THE PROCEDURE. THE PROCEDURE WAS RESUMED, WITHOUT ANY DELAY, USING THE SAME DEVICE. NO INJURY WAS REPORTED AS A CONSEQUENCE OF THIS ISSUE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21820097 ↗
• MalfunctionJul 20, 2023Break; Break

  IT WAS REPORTED THAT, AT AN UNKNOWN TIME DURING A TKA, THE GII PRIM P/S COLLET W/THMBSCRW BROKE. IT IS UNKNOWN IF THIS CAUSED A DELAY, HOW THE PROCEDURE WAS FINISHED, OR IF BROKEN PIECES HAD TO BE EXTRACTED FROM THE PATIENT. NO PATIENT HARM REPORTED AT THIS TIME.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17367396 ↗
• MalfunctionMay 12, 2023Fracture; Fracture

  IT WAS REPORTED THAT DURING A TKA SURGERY, A SCREW OF THE GII PRIM P/S COLLET W/THMBSCRW SNAPPED OFF WHILE BEING ADDED TO THE CUTTING BLOCK. THE PROCEDURE WAS RESUMED, WITHOUT ANY DELAY, USING A S+N BACK-UP DEVICE. PATIENT WAS NOT INJURED AS CONSEQUENCE OF THIS PROBLEM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16924663 ↗
• InjuryFeb 16, 2022Break; Break

  IT WAS REPORTED THAT, DURING A TKA SURGERY, THE SURGEON WAS TRYING TO TIGHTEN THE GII PRIM P/S COLLET W/THMBSCRW DOWN BUT IT WASN'T FULLY TIGHTENING. THEN WHEN DOING HIS PS REAMER AND BOX CHISEL, THE THUMBSCREW MECHANISM BROKE APART ON HIM INSIDE THE PATIENT. ALL PIECES WERE RECOVERED WITH PICKUPS. THE PROCEDURE WAS COMPLETED, WITH A DELAY OF FEWER THAN 30 MINUTES, USING THE SAME DEVICE. PATIENT WAS NOT HARMED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13540271 ↗
• MalfunctionJul 14, 2021Break; Break

  IT WAS REPORTED THAT, DURING A TKR SURGERY, A GENESIS II PRIM P/S COLLET W/THMBSCRW SCREW SHEARED OFF. SURGERY WAS COMPLETED WITH A BACKUP DEVICE, WITHOUT ANY DELAY. AS THIS WAS NOTICED DURING SET UP, THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12166178 ↗
• MalfunctionOct 14, 2020Break; Break

  IT WAS REPORTED THAT DURING THE PROCEDURE, THE GOLD WHEEL BROKE WHEN UNSCREWING IT FROM THE BLOCK. THE PROCEDURE WAS COMPLETED WITHOUT DELAY AND BACKUP FROM SMITH&NEPHEW WAS AVAILABLE TO FINISH THE SURGERY. NO PATIENT INJURY/HARM OR OTHER COMPLICATIONS AT THE MOMENT. 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 10681834 ↗
• InjuryOct 14, 2020Break; Break

  IT WAS REPORTED THAT DURING PROCEDURE OF A GEN II PS TKR. ON COMPLETION OF THE PS BOX PREPARATION, WHILE REMOVING THE PREPARATION GUIDE (INSTRUMENT INSIDE THE PATIENT) THE SCREW IN THE THUMBSCREW BROKE. ALL PIECES WERE RECOVERED. THE PROCEDURE WAS COMPLETED WITHOUT DELAY WITH THE SAME DEVICE. THE PATIENT IS WELL.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 10681496 ↗
• MalfunctionDec 15, 2019Break; Break

  IT WAS REPORTED THAT DURING SURGERY THE SURGEON BROKE OFF THE GOLD KNOB OF THE INSTRUMENT WITH A MALLET ON ACCIDENT INSIDE THE PATIENT. ALL PIECES WERE RETRIEVED FROM THE PATIENT. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITH THE SAME DEVICE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9471065 ↗
• MalfunctionMar 23, 2018Insufficient Device Problem Information

  A DEVICE MALFUNCTION WAS IDENTIFIED THAT, UPON REOCCURRENCE, MAY NECESSITATE MEDICAL INTERVENTION AND/OR RESULT IN AN EXTENDED SURGICAL DELAY.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7364832 ↗

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