GENESIS II 71440078Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 03596010213884), received between Jan 27, 2022 and Oct 4, 2022 — classified as 1 injury, 2 malfunctions.

The most frequently reported specific device problem is “Break” (2 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 18, 2026.

Most reported problems

Recent adverse event reports

The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• MalfunctionOct 4, 2022Break; Positioning Failure; Break; Positioning Failure

  IT WAS REPORTED THAT THE LOCKING PEGS OF A GII MODULAR FEMORAL SLOT HAVE BROKEN AND NO LONGER LOCK INTO THE CUTTING BLOCK. IT IS UNKNOWN WHETHER THIS PROBLEM WAS NOTICED IN A SURGICAL ENVIRONMENT OR NOT; THEREFORE, PATIENT INVOLVEMENT HAS NOT BEEN CONFIRMED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15535770 ↗
• InjuryAug 29, 2022Fracture; Fracture

  IT WAS REPORTED THAT DURING A TKA, WHEN THE SURGEON WAS PERFORMING THE FEMORAL CUTS, USING A GII MODULAR FEMORAL SLOT, HE FELT SOME RESISTANCE. HE CONTINUED THE CUT THINKING IT WAS VERY SCLEROTIC BONE, BUT ON REMOVAL OF THE SLOT, HE NOTICED THAT THERE WERE SOME METAL DEBRIS AND THAT PARTS OF THE LOCKING POSTS WERE BROKEN. HE REMOVED THE METAL DEBRIS AND CONTINUED PERFORMING ALL THE CUTS. SURGERY WAS PERFORMED, AFTER A NON-SIGNIFICANT DELAY, WITH THE SAME DEVICE. PATIENT WAS NOT INJURED BEYOND THE ISSUE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15316055 ↗
• MalfunctionJan 27, 2022Break; Break

  IT WAS REPORTED THAT THE GII MODULAR FEMORAL SLOT HAD A BROKEN LUG. AS THIS WAS NOTICED UPON CLEANING AND STERILIZATION ACTIVITIES, THERE WAS NOT PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13365019 ↗

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