GENESIS II 71440183Recalls & reported problems

Summary

The FDA's MAUDE database contains 14 adverse event reports that list this exact device (DI 03596010329868), received between Nov 12, 2018 and Jun 12, 2026 — classified as 1 injury, 13 malfunctions.

The most frequently reported specific device problem is “Break” (9 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 14 most recent of 14 reports, in the reporter's own words as published by the FDA.

• MalfunctionJun 12, 2026Break

  IT WAS REPORTED THAT, DURING A THA SURGERY, TWO (2) GII FEM LUG PUNCH BROKE. THE PROCEDURE WAS RESUMED, WITHOUT ANY DELAY, USING AN EQUIVALENT S+N BACK-UP. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25484761 ↗
• MalfunctionJan 19, 2022Break; Break

  IT WAS REPORTED THAT THE GII FEM LUG PUNCH 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 13292350 ↗
• MalfunctionJul 15, 2021Break; Break

  IT WAS REPORTED THAT, AFTER A TKR A GII ARTICULAR INSERTER/ EXTRACT AND A GII FEM LUG PUNCH WERE BROKEN. SURGERY HAD BEEN COMPLETED, WITHOUT ANY DELAY, WITH A THE SAME DEVICE. PATIENT WAS NOT HARMED AS CONSEQUENCE TO THIS PROBLEM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12173325 ↗
• MalfunctionJun 2, 2021Material Twisted/Bent; Physical Resistance/Sticking; Material Twisted/Bent; Physical Resistance/Sticking

  IT WAS REPORTED THAT DURING DECONTAMINATION AFTER A TKA, IT WAS NOTICED THAT THE TIP OF A GII FEM LUG PUNCH WAS BENT AND WOULD NOT ALLOW THE SLIDING MECHANISM TO SLIDE (CASE: (B)(4)). ALSO, THE HEAD OF A GII TIBIAL BASE IMPACTOR WAS CRACKED ALL THE WAY THROUGH. THERE WAS NO SIGNIFICANT DELAY AND THE PROCEDURE WAS FINISHED USING THE SAME DEVICES. PATIENT WAS NOT HARMED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11921755 ↗
• MalfunctionMay 13, 2021Naturally Worn; Naturally Worn

  IT WAS REPORTED THAT THE GII FEM LUG PUNCH HAD THE ENDS OF PUNCH BADLY WORN AND PUNCH MECHANISM STIFF. IT IS UNKNOWN IF THE EVENT HAPPENED DURING A SURGICAL PROCEDURE, IF THERE WAS A SURGICAL DELAY, BACKUP DEVICE AVAILABLE OR PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11816861 ↗
• MalfunctionMay 10, 2021Physical Resistance/Sticking; Physical Resistance/Sticking

  IT WAS REPORTED THAT, DURING A TKA SURGERY, A GII FEM LUG PUNCH WAS NOTICED TO BE STUCK. NO SIGNIFICANT SURGICAL DELAY WAS REPORTED AS A SMITH AND NEPHEW BACK UP DEVICE WAS AVAILABLE. NEITHER PATIENT INJURY NOR OTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11803201 ↗
• MalfunctionApr 27, 2021Break; Break

  IT WAS REPORTED THAT THE SPRING OF A GII FEM LUG PUNCH BROKE. NO CASE INVOLVED; THEREFORE, THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11734480 ↗
• MalfunctionApr 26, 2021Break; Break

  IT WAS REPORTED THAT A BROKEN SPRING WAS FOUND INSIDE THE GII FEM LUG PUNCH. NO CASE REPORTED; THEREFORE, THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11729565 ↗
• MalfunctionFeb 14, 2021Mechanical Jam; Mechanical Jam

  IT WAS REPORTED THAT, DURING A TKA THE GII FEM LUG PUNCH STICK DID NOT SPRING BACK. THE PROCEDURE WAS COMPLETED WITHOUT DELAY USING SAME DEVICE. NO PATIENT INJURY OR OTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11326136 ↗
• MalfunctionFeb 11, 2021Break

  IT WAS REPORTED THAT DURING TKA PROCEDURE THE GENESIS II FEM LUG PUNCH BROKE OUTSIDE THE PATIENT. THE PROCEDURE WAS COMPLETED WITHOUT DELAY WITH AN SMITH&NEPHEW BACKUP DEVICE. NO PATIENT HARM OR ADDITIONAL COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11319820 ↗
• MalfunctionDec 28, 2020Break; Break

  IT WAS REPORTED THAT DURING USE IN A TOTAL KNEE ARTHROPLASTY THE GENESIS II FEM LUG PUNCH BROKE. NO INJURY OR DELAY REPORTED. THE PROCEDURE WAS FINISHED USING A SMITH AND NEPHEW BACKUP DEVICE. 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 11083220 ↗
• InjuryDec 13, 2020Break; Break

  IT WAS REPORTED THAT, DURING TKA SURGERY, THE GENESIS II FEM LUG PUNCH BROKE INTO TWO PIECES DURING MID-IMPACT. IT IS UNKNOWN HOW THE PROCEDURE WAS FINISHED AND IF THERE WAS A SURGICAL DELAY. 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 10999123 ↗
• MalfunctionMay 9, 2019Fracture; Fracture

  IT WAS REPORTED THAT DURING SURGERY, INSTRUMENT BROKE ABOVE THE INCISION. NO PIECES FELL INTO THE PATIENT AND NO INJURY REPORTED, NO DELAY AND PROCEDURE WAS CONCLUDED WITH A BACKUP DEVICE FROM SMITH AND NEPHEW.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8597356 ↗
• MalfunctionNov 12, 2018Break

  IT WAS REPORTED THAT DURING TKA THE LUG PUNCH GOT STUCK IN THE "UP" POSITION. BROKE IN PATIENT WHILE IMPACTING THE FEMUR. ALL PIECES ACCOUNTED FOR. NO DELAY OR INJURY REPORTED. PROCEDURE FINISHED WITH THE SAME DEVICE.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8062400 ↗

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