GENESIS II 71441252Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00885556034767), received between Jul 31, 2018 and Jul 2, 2021 — classified as 3 malfunctions.

The most frequently reported specific device problem is “Break” (1 report).

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.

• MalfunctionJul 2, 2021Break; Break

  IT WAS REPORTED THAT, DURING THE SET UP FOR A TKA, THE LOCKING MECHANISM OF A GII SPC ACF EXT ROT PAD RT BROKE. THE PROCEDURE WAS PERFORMED, WITHOUT ANY DELAY, USING A S+N BACK-UP DEVICE. PATIENT WAS NOT IMPACTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12112081 ↗
• MalfunctionMay 27, 2021Material Twisted/Bent; Material Twisted/Bent

  IT WAS REPORTED THAT DURING A TKA, WHILE REMOVING THE ROTATION PADDLES OF A GENESIS II SPC ACF EXT ROT PAD RIGHT FROM THE BLOCK, THE SKINNY METAL PIECE GOT BENT RENDERING THE PADDLES INOPERABLE. THERE WAS NO SIGNIFICANT DELAY AND THE PROCEDURE WAS FINISHED USING THE SAME DEVICE. PATIENT WAS NOT HARMED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11895190 ↗
• MalfunctionJul 31, 2018Loose or Intermittent Connection; Loose or Intermittent Connection

  IT WAS REPORTED A MALFUNCTION IN WHICH THE SURGEON WAS TAKING THE PADDLES OFF THE FEMUR AND THE CENTER SCREW IN THE MIDDLE CAME OUT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7734966 ↗

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