GENESIS II 71440818Recalls & reported problems

Summary

The FDA's MAUDE database contains 11 adverse event reports that list this exact device (DI 03596010390387), received between Dec 30, 2020 and Sep 19, 2024 — classified as 2 injuries, 9 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 11 most recent of 11 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 19, 2024Fracture; Fracture

  IT WAS REPORTED THAT, DURING A TKA SURGERY, A PIN FROM ONE (1) GII POST REF A/P BLK SZ 5 SNAPPED OFF. ALL PIECES WERE RETRIEVED USING FORCEPS. THE PROCEDURE WAS RESUMED, AFTER A NON-SIGNIFICANT DELAY, USING THE SAME DEVICE. NO INJURY WAS REPORTED AS A RESULT OF THIS ISSUE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20258753 ↗
• MalfunctionFeb 4, 2023Fracture; Fracture

  IT WAS REPORTED THAT DURING TKA SURGERY WHEN THE SURGEON IMPACTED THE GII POST REF A/P BLK SZ 5 ONTO THE PATIENT THE PINS BROKE OFF. THE PROCEDURE WAS COMPLETED, WITH A NON-SIGNIFICANT DELAY, USING A S+N BACK-UP DEVICE. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16301736 ↗
• MalfunctionJun 2, 2022Break; Break

  IT WAS REPORTED THAT UPON IMPACTION OF INSTRUMENT DURING THA, THE PIN OF THE GII POST REF A/P BLK SZ 5 BROKE OFF DUE TO GENERAL WEAR AND TEAR. A SMITH AND NEPHEW BACK UP DEVICE WAS AVAILABLE. NO INJURY TO PATIENT OR SIGNIFICANT SURGICAL DELAY WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14580581 ↗
• InjuryMar 23, 2022Break; Break

  IT WAS REPORTED THAT, DURING A TKA SURGERY, WHILST IMPACTING A GII POST REF A/P BLK SZ 5 INTO POSITION, ONE OF THE PINS AT THE BACK SHEARED OFF AND HAD TO BE REMOVED FROM THE BONE. PROCEDURE WAS COMPLETED, AFTER A NON SIGNIFICANT DELAY, WITH A S+N BACK UP DEVICE. NO OTHER COMPLICATIONS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13863740 ↗
• MalfunctionFeb 21, 2022Break; Break

  IT WAS REPORTED THAT, DURING A TKA SURGERY, THE GII POST REF A/P BLK SZ 5 WAS BROKEN. THE PROCEDURE WAS FINISHED WITH A SMITH AND NEPHEW BACK UP DEVICE WITHOUT DELAY. THE PATIENT WAS NOT HARMED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13573269 ↗
• MalfunctionFeb 10, 2022Break; Break

  IT WAS REPORTED THAT, DURING TKA SET UP, THE PIN OF THE GENESIS II POST THAT HOLDS IT INTO THE BONE HAS SHEARED OFF. PROCEDURE WAS PERFORMED, WITHOUT ANY DELAY, WITH A BACK-UP DEVICE INSTEAD. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13505978 ↗
• MalfunctionSep 21, 2021Break; Break

  IT WAS REPORTED THAT, DURING A TKA SURGERY, A PIN OF A GENESIS II POST REFLECTION A/P BLK SIZE 5 BROKE THE CUTTING BLOCK. THE PROCEDURE WAS COMPLETED WITH THE SAME DEVICE WITHOUT DELAY. THE PATIENT WAS NOT HARMED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12509484 ↗
• MalfunctionAug 26, 2021Break; Break

  IT WAS REPORTED THAT, BEFORE A TKA SURGERY, DURING SET UP, ONE GII POST REF A/P BLK SZ 5 SNAPPED OFF. THIS HAPPENED BEFORE USE IN PATIENT. SURGERY WAS PERFORMED, WITHOUT ANY DELAY, WITH A SMITH AND NEPHEW BACK-UP DEVICE INSTEAD. NO HEALTH CONSEQUENCES WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12374628 ↗
• MalfunctionMay 4, 2021Break; Break

  IT WAS REPORTED THAT AFTER STERILIZATION, IT WAS FOUND THAT THE GII POST REF A/P BLK SZ 5 HAD A BROKEN PIN. NO CASE REPORTED; THEREFORE, THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11772739 ↗
• InjuryFeb 9, 2021Break; Break

  IT WAS REPORTED THAT ONE OF THE PINS ON THE BACK OF THE GENESIS II POSTERIOR REFERENCING ANTERIOR/POSTERIOR CUTTING BLOCK SIZE 5 SNAPPED OFF. NO CASE INVOLVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11305620 ↗
• MalfunctionDec 30, 2020Break; Break

  IT WAS REPORTED THAT DURING TKA PROCEDURE THE GII POST REF A/P BLK SZ 5 BROKE OFF WHEN BEING USED INSIDE THE PATIENT. THERE WAS NO DELAY. PROCEDURE CONCLUDED USING A S&N BACK UP DEVICE. NO OTHER COMPLICATIONS REPORTED AT THIS TIME.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11094663 ↗

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