GENESIS II 71440824Recalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 03596010407375), received between Oct 23, 2020 and Aug 4, 2025 — classified as 1 injury, 4 malfunctions.

The most frequently reported specific device problem is “Break” (3 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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 5 most recent of 5 reports, in the reporter's own words as published by the FDA.

• MalfunctionAug 4, 2025Fracture; Fracture

  IT WAS REPORTED THAT, DURING A TKA SURGERY, A PIN OF ONE (1) GII POST REF A/P BLK SZ 8 HAD FRACTURED AND REMAINED IN THE PATIENT. THE SURGEON USED A BONE NIBBLER TO GRIP AND REMOVE THE BROKEN PIN. THE PROCEDURE WAS COMPLETED WITH THE DEVICE, THE ISSUE WAS DISCOVERED AS THE DEVICE WAS BEING REMOVED, THIS CAUSED A NON-SIGNIFICANT DELAY. NO INJURY WAS REPORTED AS A CONSEQUENCE OF THIS ISSUE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22709877 ↗
• MalfunctionJun 30, 2025Fracture; Fracture

  IT WAS REPORTED THAT DURING A TKA, THE GII POST REF A/P BLK SZ 8 SHEARED AWAY FROM ATTACHMENT PINS, LEAVING THE PINS IN SITU IN PATIENT FEMUR WHICH HAD TO BE REMOVED WITH SURGICAL PLIERS AND OSTEOTOMES. SURGERY WAS PERFORMED AFTER A NON-SIGNIFICANT DELAY, WITH A BACK-UP DEVICE. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22353266 ↗
• MalfunctionFeb 22, 2022Break; Break

  IT WAS REPORTED THAT DURING SET UP FOR A TKA SURGERY, THE PIN OF A GII POST REF A/P BLK SZ 8 SNAPPED OFF OF THE BACK OF THE BLOCK. THE PROCEDURE WAS COMPLETED, WITHOUT DELAY, USING A SMITH AND NEPHEW BACK UP DEVICE. SINCE INCIDENT OCCURRED BEFORE PROCEDURE, PATIENT WAS NOT INVOLVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13580622 ↗
• MalfunctionApr 2, 2021Break; Break

  IT WAS REPORTED THAT, A PIN OF A GENESIS II POST REFLECTION A/P BLK SIZE 8 BROKE OFF AT BACK OF BLOCK. INCIDENT OCCURRED DURING A TKA WITH INSTRUMENTS OUTSIDE THE PATIENT. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITHOUT DELAY USING A BACK-UP DEVICE. NO PATIENT INJURY OR OTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11610609 ↗
• InjuryOct 23, 2020Break; Break

  IT WAS REPORTED THAT DURING A TOTAL KNEE ARTHROPLASTY THE CUTTING BLOCK WAS PLACED ON THE FEMUR, HIT INTO PLACE WITH THE HAMMER, AND CUTS WERE MADE. WHEN THE CUTTING BLOCK WAS REMOVED, IT WAS NOTICED THAT THE SECURING PIN/SPIKE ON THE BACK OF CUTTING BLOCK HAD SNAPPED OFF AND WAS STUCK IN THE FEMUR. THE PIECES WERE REMOVED BY THE SURGEON WITH FORCEPS. ANOTHER DEVICE WAS NOT NECESSARY. THE PROCEDURE WAS FINISHED USING THE SAME DEVICE. NO DELAY OR PATIENT INJURY WAS REPORTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 10730896 ↗