GENESIS II 71430179Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 03596010211569), received between Nov 9, 2020 and Nov 30, 2023 — classified as 1 injury, 2 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.

• InjuryNov 30, 2023Positioning Problem; Positioning Problem

  IT WAS REPORTED THAT, DURING A TKA SURGERY, THE PIN HOLES OF A GNS II STEMLESS TIB TR SZ 2 RT WERE FOUND TO BE IN THE WRONG PLACE AND THE POLYMER TRIAL WOULD NOT SEAT OVER ITS PINS. SURGERY WAS RESUMED, AFTER A NON-SIGNIFICANT DELAY, WITH A S+N BACK-UP DEVICE WITH THE SAME PART NUMBER; NEW PIN HOLES HAD TO BE MADE. NO FURTHER INJURY WAS REPORTED DUE TO THIS ISSUE.

  Patient problems: Perforation

  MAUDE report 18241081 ↗
• MalfunctionNov 16, 2021Crack; Crack

  IT WAS REPORTED THAT, DURING SET-UP/INSPECTION OF A TOTAL KNEE ARTHROPLASTY CASE, THE BASEPLATE OF A GENESIS II STEMLESS TIBIAL TRAY SIZE 2 RIGHT WAS OBSERVED TO BE CHIPPED. SURGERY WAS PERFORMED, WITHOUT ANY DELAY, WITH A SMITH & NEPHEW BACK-UP DEVICE INSTEAD. PATIENT WAS NOT INJURED AS CONSEQUENCE OF THIS PROBLEM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12820114 ↗
• MalfunctionNov 9, 2020Break; Break

  IT WAS REPORTED THAT THE GNS II STEMLESS TIB TR SZ 2 RT WAS FOUND CHIPPED IN THE CENTERED FIN PUNCH HOLE. THE TIBIAL STEM DRILL WOULD NOT STAY CENTERED AS A RESULT. NO CASE RELATED, THEREFORE NO PATIENT INVOLVED. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED. IF ADDITIONAL INFORMATION SHOULD BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED ACCORDINGLY.

  Patient problems: No Patient Involvement

  MAUDE report 10812420 ↗

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