GENESIS II 71440004Recalls & reported problems

Summary

The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 03596010213723), received between Jun 29, 2018 and Sep 20, 2021 — classified as 6 malfunctions.

The most frequently reported specific device problem is “Break” (5 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 6 most recent of 6 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 20, 2021Break; Break

  IT WAS REPORTED, THAT A GENESIS II LONG I/M ROD 16 INCH WAS FOUND CHIPPED. NO CASE REPORTED; THEREFORE, THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12494518 ↗
• MalfunctionJul 29, 2021Break; Material Twisted/Bent; Break; Material Twisted/Bent

  IT WAS REPORTED THAT, DURING A FIELD INSPECTION, THESE DEVICES WERE FOUND WITH ISSUES: GII LONG I/M ROD 16 INCH WAS FOUND BROKEN AND BENT (CASE (B)(4)), A LARGE OUTER CASE - 4.8 (CASE (B)(4)) AND A LID FOR OUTER CASES (CASE (B)(4)) WERE FOUND CRACKED, AND A G2 CON ARTI TR SZ3-4 11MM (CASE (B)(4)) WAS FOUND WITH BURRS, NICKS, SCRATCHES AND/OR GOUGES. NO CASE INVOLVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12250730 ↗
• MalfunctionOct 16, 2020Break; Break

  IT WAS REPORTED THAT THE PROXIMAL END OF THE ROD BROKE OFF WHEN REMOVING. IT OCCURRED DURING USE, WITH INSTRUMENTS OUTSIDE THE PATIENT. NO PIECES FELL INSIDE THE PATIENT AND ALL PIECES WERE RECOVERED. NO PATIENT INJURY OR SURGICAL DELAY WAS REPORTED. THE PROCEDURE WAS COMPLETED WITH THE SAME DEVICE. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED. IF ADDITIONAL INFORMATION SHOULD BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED ACCORDINGLY.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 10693256 ↗
• MalfunctionJul 23, 2020Break; Break

  IT WAS REPORTED THAT THE IM ROD IS CHIPPED AND WORN. NO CASE 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 10312318 ↗
• MalfunctionJan 31, 2019Break; Break

  IT WAS REPORTED THAT DURING SURGERY THE ROD WAS BROKEN. THE INSTRUMENT BROKE INSIDE THE PATIENT. S&N BACKUP DEVICE AVAILABLE AND THE PROCEDURE WAS DELAYED LESS THAN 30 MINUTES DUE TO THIS INCIDENT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8293014 ↗
• MalfunctionJun 29, 2018Blocked Connection; Blocked Connection

  IT WAS REPORTED THAT SURGEON PLACED IM ROD INTO THE FEMUR FIRMLY AND BECAME STUCK IN THE CANAL WITH T-HANDLE VERY FIRMLY AND ROD WOULDN¿T COME OUT USED MORE FORCE ROD, CAME OUT. ROD IS BENT AND RIDGES ARE TWISTED.

  Patient problems: No Information

  MAUDE report 7653189 ↗

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