GENESIS II 71441140Recalls & reported problems

Summary

The FDA's MAUDE database contains 10 adverse event reports that list this exact device (DI 03596010001245), received between Mar 1, 2019 and Sep 13, 2022 — classified as 10 malfunctions.

The most frequently reported specific device problem is “Break” (8 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 10 most recent of 10 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 13, 2022Fracture; Fracture

  IT WAS REPORTED THAT, DURING A TKA, THE END OF A GII MIS DCF SIZING STYLUS BROKE OFF, HOWEVER, NO PIECES FELL INTO THE PATIENT, AND THE BROKEN PIECES WERE DISCARDED BY HOSPITAL STAFF. SURGERY WAS PERFORMED, WITHOUT ANY DELAY, WITH A SMITH AND NEPHEW BACKUP DEVICE INSTEAD. THE PATIENT WAS NOT INJURED AS A CONSEQUENCE OF THIS PROBLEM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15412226 ↗
• MalfunctionMay 20, 2022Break; Break

  IT WAS REPORTED THAT A GENESIS II SIZING STYLUS IS BROKEN. AS THIS WAS NOTICED UPON FIELD INSPECTION, THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14450756 ↗
• MalfunctionJul 21, 2021Break; Break

  IT WAS REPORTED THAT THE LUG OF A GII MIS DCF SIZING STYLUS HAS FALLEN 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 12201283 ↗
• MalfunctionApr 26, 2021Material Separation; Material Separation

  IT WAS REPORTED THAT AFTER STERILIZATION, IT WAS NOTICED THAT THE GENESIS II MIS DCF SIZING STYLUS WAS MISSING THE ADJUSTMENT KNOB. NO CASE INVOLVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11729706 ↗
• MalfunctionApr 5, 2021Break; Break

  IT WAS REPORTED THAT DURING TKA SURGERY, THE SIZING STYLUS BROKE OUTSIDE THE PATIENT. THE PROCEDURE FINISHED USING A BACKUP DEVICE FROM SMITH AND NEPHEW, WITHOUT SURGICAL DELAY AND NO INJURY TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11612168 ↗
• MalfunctionMar 17, 2021Break; Loose or Intermittent Connection; Break; Loose or Intermittent Connection

  IT WAS REPORTED THAT, THE BACK KNOB OF A GENESIS II MIS DCF SIZING STYLUS CAME OFF. INCIDENT OCCURRED DURING A TKA WITH INSTRUMENTS OUTSIDE THE PATIENT. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITHOUT DELAY USING A BACK-UP DEVICE. NO PATIENT INJURY OR OTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11499997 ↗
• MalfunctionMar 16, 2021Break; Loose or Intermittent Connection; Break; Loose or Intermittent Connection

  IT WAS REPORTED THAT, THE BACK KNOB OF A GENESIS II MIS DCF SIZING STYLUS CAME OFF. INCIDENT OCCURRED DURING A TKA WITH INSTRUMENTS OUTSIDE THE PATIENT. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITHOUT DELAY USING A BACK-UP DEVICE. NO PATIENT INJURY OR OTHER COMPLICATIONS WERE REPORTED. NO PATIENT INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11496132 ↗
• MalfunctionMar 15, 2021Break; Loose or Intermittent Connection; Break; Loose or Intermittent Connection

  IT WAS REPORTED THAT, THE BACK KNOB OF A GENESIS II MIS DCF SIZING STYLUS CAME OFF. INCIDENT OCCURRED DURING A TKA WITH INSTRUMENTS OUTSIDE THE PATIENT. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITHOUT DELAY USING A BACK-UP DEVICE. NO PATIENT INJURY OR OTHER COMPLICATIONS WERE REPORTED. NO PATIENT INFORMATION AVAILABLE. 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 11480637 ↗
• MalfunctionMar 15, 2021Break; Loose or Intermittent Connection; Break; Loose or Intermittent Connection

  IT WAS REPORTED THAT, THE BACK KNOB OF A GENESIS II MIS DCF SIZING STYLUS CAME OFF. INCIDENT OCCURRED DURING A TKA WITH INSTRUMENTS OUTSIDE THE PATIENT. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITHOUT DELAY USING A 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 11480623 ↗
• MalfunctionMar 1, 2019Break; Break

  IT WAS REPORTED THAT DURING SURGERY, DEVICE BROKE. IT IS UNKNOWN IF THERE WAS A BACKUP OR A DELAY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8380850 ↗

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