GENESIS II 71440322Recalls & reported problems

Summary

The FDA's MAUDE database contains 7 adverse event reports that list this exact device (DI 03596010214980), received between Feb 21, 2021 and Dec 29, 2025 — classified as 1 injury, 6 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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 7 most recent of 7 reports, in the reporter's own words as published by the FDA.

• MalfunctionDec 29, 2025Fracture; Fracture

  IT WAS REPORTED THAT, DURING A TKA SURGERY, THE BLACK BUMPER OF ONE (1) GII PATELLAR CEMENT CLAMP BROKE OFF. NO PIECES FELL INSIDE PATIENT. 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 23907978 ↗
• MalfunctionDec 31, 2023Fracture; Fracture

  IT WAS REPORTED THAT DURING A TKA SURGERY WHILE IMPACTING THE GII PATELLAR CEMENT CLAMP THE HEAD BROKE OFF. THE PROCEDURE WAS RESUMED, WITHOUT ANY DELAY, USING A S+N BACK-UP DEVICE. NO INJURY WAS REPORTED AS A CONSEQUENCE OF THIS ISSUE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18423035 ↗
• MalfunctionMar 16, 2022Break; Break

  IT WAS REPORTED THAT DURING INSPECTION OF THE RETURNED TRAY, THE GII PATELLAR CEMENT CLAMP WAS BROKEN. IT IS UNKNOWN WHEN THE DEVICE BROKE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13778246 ↗
• InjuryFeb 27, 2022Break; Break

  IT WAS REPORTED THAT, DURING TOTAL KNEE ARTHROPLASTY, WHILE REMOVING A GENESIS II PATELLAR CEMENT CLAMP FROM THE PATELLA ONCE THE CEMENT HAD CURED, THE SURGEON SPUN THE GOLD KNOB AND IT ALL CAME OFF, WHILE IT WAS INSIDE THE PATIENT. THE SMALL STOP ON THE END OF THE CLAMP TO STOP THIS FROM HAPPENING HAS COME OFF. SURGERY WAS RESUMED, WITHOUT ANY DELAY, WITH THE SAME DEVICE. PATIENT WAS NOT HARMED AS CONSEQUENCE OF THIS PROBLEM. THE PATIENT WAS X-RAYED AFTER CLOSURE TO ENSURE THE BROKEN PIECE WAS NOT LEFT INSIDE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13615116 ↗
• MalfunctionOct 8, 2021Break; Break

  IT WAS REPORTED THAT, DURING A TKA SURGERY, A GII PATELLAR CEMENT CLAMP BROKE. IT IS UNKNOWN WHETHER THE EVENT HAPPENED DURING USE IN PATIENT AND IF THERE WAS PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12597990 ↗
• MalfunctionSep 2, 2021Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT, AFTER A TKA PROCEDURE, THE BLACK PLASTIC TIP OF A GII PATELLAR CEMENT CLAMP CAME OUT AFTER TRYING TO REMOVE THE LARGER ROUND PLASTIC PIECE. AS THIS WAS NOTICED AFTER SURGERY, NO SURGICAL DELAY OCCURRED AND THE PROCEDURE WAS CONCLUDED WITH THE SAME DEVICE. NO PATIENT HARM REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12418378 ↗
• MalfunctionFeb 21, 2021Break; Break

  IT WAS REPORTED THAT DURING INSPECTION, CLAMP WAS FOUND TO BE BROKEN WHEN IT WAS OPENED. A BACKUP DEVICE FROM SMITH AND NEPHEW WAS USED TO COMPLETE THE PROCEDURE AND NO DELAY OCCURRED DUE TO THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11356743 ↗

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