NA 71353603Recalls & reported problems

Summary

The FDA's MAUDE database contains 7 adverse event reports that list this exact device (DI 03596010479693), received between Sep 23, 2020 and Jan 9, 2023 — classified as 1 injury, 6 malfunctions.

The most frequently reported specific device problem is “Break” (3 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 7 most recent of 7 reports, in the reporter's own words as published by the FDA.

• MalfunctionJan 9, 2023Fracture; Fracture

  IT WAS REPORTED THAT, DURING SURGERY, THE LOCKING MECHANISM OF TWO (2) TRIAL 12/14 FEM HEAD 36MM -3 BROKE. SURGERY WAS PERFORMED WITHOUT ANY DELAY WITH A SN BACK-UP DEVICE. NO HARM TO THE PATIENT OR FURTHER COMPLICATIONS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16122928 ↗
• MalfunctionNov 29, 2022Fracture; Fracture

  IT WAS REPORTED THAT, DURING A THR, THE INSIDE OF A TRIAL 12/14 FEM HEAD 36MM -3 THAT LATCHES ONTO THE STEM TRIAL WAS BROKEN. ADDITIONALLY, NO PIECES FELL INTO THE PATIENT. SURGERY WAS RESUMED, WITHOUT ANY DELAY, WITH A BACKUP DEVICE. THE PATIENT WAS NOT HARMED AS A CONSEQUENCE OF THIS PROBLEM. 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 15875787 ↗
• MalfunctionAug 19, 2021Break; Break

  IT WAS REPORTED THAT, UPON LOANER RETURN INSPECTION, A TRIAL 12/14 FEM HEAD 36MM -3 WAS FOUND TO BE BROKEN APART DUE TO IMPACTION. AS THIS WAS NOTICED UPON INSPECTION, THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12343297 ↗
• MalfunctionMar 29, 2021Crack; Crack

  IT WAS REPORTED THAT TWO OF THE TRIAL 12/14 FEM HEAD 36MM -3 ARE CRACKED AND NO LONGER USABLE. IT IS UNKNOWN WHETHER THE EVENT HAPPENED DURING SURGERY AND IF THERE WAS PATIENT INVOLVEMENT. ADDITIONAL INFORMATION HAVE NOT BEEN PROVIDED AT THIS TIME.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11586408 ↗
• MalfunctionMar 29, 2021Crack; Crack

  IT WAS REPORTED THAT TWO OF THE THE TRIAL 12/14 FEM HEAD 36MM -3 ARE CRACKED AND NO LONGER USABLE. IT IS UNKNOWN WHETHER THE EVENT HAPPENED DURING SURGERY AND IF THERE WAS PATIENT INVOLVEMENT. ADDITIONAL INFORMATION HAVE NOT BEEN PROVIDED AT THIS TIME.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11586407 ↗
• MalfunctionNov 17, 2020Break; Break

  IT WAS REPORTED THAT THE 36 -3MM TRIAL HEAD WILL NOT SEAT ON TRIAL STEM AS INNER FLANGE HAS BROKEN OFF NOT ALLOWING THE TRIAL HEAD TO SEAT. 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 10855853 ↗
• InjurySep 23, 2020Break; Break

  IT WAS REPORTED THAT THE MECHANISM WHICH HOLDS THE HEAD TO THE TRIAL NECK BROKE OFF INTERNAL TO THE PATIENT, DURING THR SURGERY. THE PROCEDURE WAS FINISHED USING A SMITH AND NEPHEW BACK UP DEVICE, WITH NO SURGICAL DELAY AND NO INJURY TO THE PATIENT.

  Patient problems: Injury

  MAUDE report 10571695 ↗

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