GENESIS II 71430844Recalls & reported problems

Summary

The FDA's MAUDE database contains 7 adverse event reports that list this exact device (DI 03596010213587), received between May 13, 2021 and Jan 12, 2026 — classified as 1 injury, 6 malfunctions.

The most frequently reported specific device problem is “Crack” (4 reports).

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

• MalfunctionJan 12, 2026Fracture

  IT WAS REPORTED THAT DURING A TKR SURGERY, ONE (1) GII P/S ART TR SZ 7-8 9MM FRACTURED. THE PATIENT PRESENTED A VERY PRONOUNCED VALGUS DEFORMITY. PREPARATIONS WERE PERFORMED ON THE FEMUR (7) AND TIBIA (7), AND THE INSERT WAS PUT IN PLACE. THE TESTS WERE CONDUCTED, AND UPON REMOVAL OF THE GII P/S ART TR SZ 7-8 9MM, IT FRACTURED. NO DAMAGE CAUSED. NO PIECES FELL INTO THE PATIENT'S WOUND. 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 24035181 ↗
• MalfunctionFeb 27, 2024Fracture; Fracture

  IT WAS REPORTED THAT DURING TKA SURGERY, A GII P/S ART TR SZ 7-8 9MM BROKE OFF. SURGERY WAS RESUMED WITHOUT ANY DELAY WITH THE SAME DEVICE. NO INJURIES TO THE PATIENT WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18788085 ↗
• MalfunctionApr 17, 2022Crack; Crack

  IT WAS REPORTED THAT, DURING A TKA SURGERY, THE GII P/S ART TR SZ 7-8 9MM WAS CRACKED. SURGERY WAS RESUMED, WITHOUT ANY DELAY, USING A S+N BACK-UP DEVICE. PATIENT WAS NOT HARMED. NO FURTHER COMPLICATIONS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14132099 ↗
• MalfunctionAug 18, 2021Crack; Crack

  IT WAS REPORTED THAT DURING A SET UP AND INSPECTION A GII P/S ART TR SZ 7-8 9MM WAS CRACKED. AS THIS WAS NOTICED UPON INSPECTION, THERE WAS NOT PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12336540 ↗
• MalfunctionJun 28, 2021Break; Break

  IT WAS REPORTED THAT A GENESIS II POSTERIOR STABILIZING ARTICULAR TRIAL SIZE 8 9MM (CASE-(B)(4)) AND A GENESIS II MODIFIED PATELLAR REAMER GUIDE (CASE-(B)(4)) BROKE. AS THIS WAS NOTICED UPON FIELD INSPECTION, THERE WAS NOT PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12076732 ↗
• MalfunctionJun 9, 2021Crack; Scratched Material; Crack; Scratched Material

  IT WAS REPORTED THAT 4 CONSTRAINED INSERT TRIALS, 4 ARTICULAR INSERT SPACER TRIALS, 4 POSTERIOR STABILIZED HIGH FLEXION INSET TRIALS AND 3 POSTERIOR STABILIZING ARTICULAR TRIALS FROM GENESIS II SYSTEM ARE BEING RETURNED FOR REPLACEMENT BECAUSE THEY'RE COVERED IN SCRATCHES, CHIPS AND CRACKS. NO CASE RELATED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11968123 ↗
• InjuryMay 13, 2021Crack; Crack

  IT WAS REPORTED THAT, DURING TKA SURGERY, A GII P/S ART TR SZ 7-8 9MM CRACKED WHEN SURGEON TRIED TO REDUCE DOWN ONTO TIBIAL INSTRUMENT INSIDE THE PATIENT. IT IS UNKNOWN IF BROKEN PIECES WERE GENERATED AND IF SO, HOW WERE THEY WERE RETRIEVED FROM PATIENT. NO SIGNIFICANT SURGICAL DELAY WAS REPORTED AS A SMITH AND NEPHEW BACKUP DEVICE WAS AVAILABLE. NEITHER PATIENT INJURY NOR OTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11820674 ↗