GENESIS II 71440012Recalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 03596010213754), received between Mar 29, 2021 and Oct 23, 2022 — classified as 5 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. 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.

• MalfunctionOct 23, 2022Break; Break

  IT WAS REPORTED THAT, THE GII VALGLUS ALIGNMENT GUIDE IS BROKEN. AS THIS MOMENT IT IS UNKNOWN WHEN DID THE EVENT HAPPENED AND IF THERE WAS A PATIENT INVOLVED. NO OTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15656582 ↗
• MalfunctionJun 8, 2021Naturally Worn; Physical Resistance/Sticking; Naturally Worn; Physical Resistance/Sticking

  IT WAS REPORTED THAT, DURING SET UP FOR A TKA SURGERY, THE GII VALGLUS ALIGNMENT GUIDE PIN SEIZED IN THE PIN HOLE DUE TO WEAR AND TEAR. 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 11962971 ↗
• MalfunctionJun 8, 2021Material Deformation; Material Deformation

  IT WAS REPORTED THAT AFTER A TKA, DURING SPD, THE GENESIS II VALGUS ALIGNMENT GUIDE'S PIN HOLE WAS CROSS-THREADED AND WOULD NOT ACCEPT DRILLS THROUGH THE HOLE ANYMORE. THERE WAS NO SIGNIFICANT DELAY SINCE IT WAS NOTICED AFTER THE PROCEDURE DURING STERILIZATION (OUTSIDE SURGERY).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11962373 ↗
• MalfunctionMar 29, 2021Connection Problem; Material Twisted/Bent; Connection Problem; Material Twisted/Bent

  IT WAS REPORTED THAT DURING INSPECTION THE GENESIS II VALGLUS ALIGNMENT GUIDE HOLDING PEGS IS DAMAGED AND BET THE INSTRUMENT DOESN'T HOLD PROPERLY. NO CASE INVOLVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11586745 ↗
• MalfunctionMar 29, 2021Break; Break

  IT WAS REPORTED THAT THE HOLDING PEG ON THE GII VALGUS ALIGNMENT GUIDE IS DAMAGED AND A SMALL PIECE CHIPPED OFF. THERE WAS NO CASE INVOLVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11586741 ↗

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