GENESIS II 71440209Recalls & reported problems

Summary

The FDA's MAUDE database contains 9 adverse event reports that list this exact device (DI 03596010460431), received between May 7, 2018 and Mar 28, 2022 — classified as 2 injuries, 7 malfunctions.

The most frequently reported specific device problem is “Break” (4 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 9 most recent of 9 reports, in the reporter's own words as published by the FDA.

• InjuryMar 28, 2022Break; Break

  IT WAS REPORTED THAT, DURING A TKA SURGERY, THE GII SLT 3 MOD TIB CUTBLCK LT WHILE DRILLING HOLES, THE DRILL BIT BROKE OFF INSIDE THE HOLD. SURGERY WAS RESUMED, WITHOUT ANY DELAY, WITH A SMITH AND NEPHEW BACK-UP DEVICE. PATIENT WAS NOT HARMED. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13926977 ↗
• MalfunctionMar 22, 2022Break; Break

  IT WAS REPORTED THAT A GENESIS II SLOTTED 3 DEGREE MODIFIED TIBIAL CUT BLOCK LEFT BROKE. SURGERY WAS RESUMED, WITHOUT ANY DELAY, WITH A BACK-UP DEVICE. PATIENT WAS NOT INJURED AS CONSEQUENCE OF THIS PROBLEM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13848798 ↗
• MalfunctionMay 19, 2021Connection Problem; Connection Problem

  IT WAS REPORTED THAT, DURING A TKA, A GII SLT 3 MOD TIB CUTBLCK LT PRESENTED PROBLEMS GETTING THE SAW BLADE THROUGH THE MEDIAL SIDE AND IT WOULD CATCH EVERY TIME; THEREFORE, WAS UNABLE TO USE. DEVICE OUTSIDE THE PATIENT. THE PROCEDURE WAS COMPLETED WITHOUT DELAY USING A S+N BACK-UP DEVICE. PATIENT WAS NOT HARMED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11849486 ↗
• MalfunctionMar 28, 2021Contamination /Decontamination Problem; Contamination /Decontamination Problem

  IT WAS REPORTED THAT, DURING SETUP OR INSPECTION IT WAS NOTICED THAT THESE INSTRUMENTS SHOWED AN OVERABUNDANCE OF BIO-FILM THAT HAS BUILT UP ON THE INSTRUMENTS OVER THE YEARS. NO CASE REPORTED; THEREFORE, THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11580416 ↗
• MalfunctionMar 25, 2021Contamination /Decontamination Problem; Contamination /Decontamination Problem

  IT WAS REPORTED THAT, DURING SETUP OR INSPECTION IT WAS NOTICED THAT THESE INSTRUMENTS SHOWED AN OVERABUNDANCE OF BIO-FILM THAT HAS BUILT UP ON THE INSTRUMENTS OVER THE YEARS. NO CASE REPORTED; THEREFORE, THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11572443 ↗
• MalfunctionDec 30, 2020Naturally Worn; Naturally Worn

  IT WAS REPORTED THAT THE LOCKING MECHANISMS HAVE BECOME WORN OUT AND ARE DIFFICULT TO USE. NO PATIENT INVOLVED IN THE CASE. 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 11097711 ↗
• MalfunctionJul 2, 2020Break; Break

  IT WAS REPORTED THAT, DURING SET UP, THE PIN THAT HOLD THE PART TOGETHER IN THE CUTTING BLOCK BROKE. A S&N BACKUP DEVICE WAS AVAILABLE DURING SURGERY. SURGERY WAS NOT DELAYED. THE PATIENT WAS NOT HARMED.

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

  MAUDE report 10227326 ↗
• MalfunctionOct 3, 2019Break; Break

  IT WAS REPORTED THAT DURING SURGERY, THE DEVICE WAS FOUND BROKEN. THE PIN AND THE LOCKING PART WERE DISASSEMBLED. THE DEVICE WILL BE RETURNED FOR EVALUATION. NO MORE INFORMATION IS AVAILABLE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9151286 ↗
• InjuryMay 7, 2018Difficult To Position; Difficult To Position

  IT WAS REPORTED THAT DURING SURGERY IS DIFFICULT TO FIX TIBIAL CUTTING BLOCK IN CORRECT POSITION, SO THE SURGEON HAD TO PROCEED WITH A RECUT.

  Patient problems: Injury

  MAUDE report 7489671 ↗

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