GENESIS II 71440200Recalls & reported problems

Summary

The FDA's MAUDE database contains 9 adverse event reports that list this exact device (DI 03596010214423), received between Oct 5, 2020 and Aug 17, 2023 — classified as 1 injury, 8 malfunctions.

The most frequently reported specific device problem is “Break” (6 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 9 most recent of 9 reports, in the reporter's own words as published by the FDA.

• MalfunctionAug 17, 2023Break; Break

  IT WAS REPORTED THAT DURING TKA SURGERY THE GOLDEN LEVER FOR THE GII INTRA TIB ALIGNMENT WAS BROKEN. THE PROCEDURE WAS RESUMED, WITHOUT ANY DELAY, USING THE SAME DEVICE. NO INJURY WAS REPORTED AS A CONSEQUENCE OF THIS ISSUE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17564882 ↗
• MalfunctionOct 6, 2022Break; Break

  IT WAS REPORTED THAT, DURING STERILIZING PROCESS, A PEG OF A GII INTRA TIB ALIGNMENT WAS BROKEN OFF. AS THIS WAS NOTICED UPON CLEANING AND STERILIZATION ACTIVITIES, THERE WAS NOT PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15551854 ↗
• MalfunctionOct 29, 2021Failure to Align; Failure to Align

  IT WAS REPORTED THAT, DURING SET-UP/INSPECTION OF A TOTAL KNEE ARTHROPLASTY CASE, A GENESIS II INTRAMEDULLARY TIBIAL ALIGNMENT ASSEMBLY FAILED TO LOCK ONTO IM ROD. SURGERY WAS RESUMED, WITHOUT ANY DELAY, WITH A SMITH & NEPHEW BACK-UP DEVICE. SINCE INCIDENT OCCURRED BEFORE PROCEDURE, PATIENT WAS NOT INVOLVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12719737 ↗
• MalfunctionMay 17, 2021Break; Break

  IT WAS REPORTED THAT, THE LOCKING MECHANISM WAS FOUND BROKEN ON GII INTRA TIB ALIGNMENT. NO CASE REPORTED; THEREFORE, THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11833106 ↗
• MalfunctionMay 10, 2021Incomplete or Inadequate Connection; Incomplete or Inadequate Connection

  IT WAS REPORTED THAT, DURING A TKA, A GII INTRA TIB ALIGNMENT HAD DIFFICULT TO PASS THROUGH. THE PROCEDURE WAS ABLE TO BE COMPLETED WITH THE SAME DEVICE. SURGERY WAS NOT DELAYED. PATIENT WAS NOT HARMED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11797850 ↗
• MalfunctionFeb 25, 2021Break; Break

  IT WAS REPORTED THAT, BEFORE A TKA PROCEDURE, DURING INSPECTION, FOR A GII INTRA TIB ALIGNMENT, THE PIECE THAT LOCKS THE ALIGNMENT TUBE TO OTHER COMPONENTS FELL OFF. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITHOUT DELAY USING A SMITH+NEPHEW BACK-UP DEVICE. NO PATIENT INJURY OR OTHER COMPLICATIONS WERE REPORTED. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED. IF ADDITIONAL INFORMATION SHOULD BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED ACCORDINGLY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11381858 ↗
• MalfunctionDec 2, 2020Break; Break

  IT WAS REPORTED THAT UPON INSPECT UPON INSPECTION, IT WAS OBSERVED THAT ONE OF THE 4 SPIKES ON THIS INSTRUMENT HAVE BROKEN OFF. NO CASE INVOLVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 10936488 ↗
• MalfunctionNov 5, 2020Connection Problem; Naturally Worn; Connection Problem; Naturally Worn

  IT WAS REPORTED THAT A GENESIS II INTRA TIB ALIGNMENT WAS WORN OUT AND WAS NOT ABLE TO LOCK DOWN, SO THE CUTTING BLOCK IS NOT SECURE. NO HARM OR INJURY REPORTED ON PATIENT. PROCEDURE WAS FINISHED WITH A SMITH AND NEPHEW BACK UP DEVICE. NO DELAY REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10791319 ↗
• InjuryOct 5, 2020Break; Break

  IT WAS REPORTED THAT ONE OF THE SPIKES FROM THE INTERMED TIBIA GUIDE BROKE OFF WHILE IMPACTING. THE PROCEDURE WAS COMPLETED WITH THE SAME DEVICE. SURGERY WAS NOT DELAYED AS CONSEQUENCE OF THE ALLEGATION. PATIENT WAS NOT HARMED.

  Patient problems: Device Embedded In Tissue or Plaque; No Clinical Signs, Symptoms or Conditions

  MAUDE report 10631966 ↗

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