NA 71369716Recalls & reported problems

Summary

The FDA's MAUDE database contains 8 adverse event reports that list this exact device (DI 03596010555625), received between Jun 19, 2019 and Jul 20, 2022 — classified as 8 malfunctions.

The most frequently reported specific device problem is “Break” (4 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 8 most recent of 8 reports, in the reporter's own words as published by the FDA.

• MalfunctionJul 20, 2022Fracture; Fracture

  IT WAS REPORTED THAT ONE (1) TRIAL FEMORAL HEAD 32 M/+4 BROKE OFF AND IS UNABLE TO RECEIVE THE NECK TRIAL. AS THIS WAS NOTICED UPON FIELD INSPECTION, NO PATIENT WAS INVOLVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15067915 ↗
• MalfunctionDec 28, 2021Break; Break

  IT WAS REPORTED THAT, DURING FIELD INSPECTION, IT WAS FOUND THAT THE BOTTOM PIECE OF A MI TRIAL FEM HEAD 36 +0, A MI TRIAL FEM HEAD 32 -3 AND A MI TRIAL FEM HEAD 32 +4 IS BROKEN SO THE NECK TRIALS CANNOT STAY ATTACHED TO THEM (CASE: (B)(4)). NO CASE INVOLVED; THEREFORE, THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13094878 ↗
• MalfunctionApr 18, 2021Loose or Intermittent Connection; Naturally Worn; Loose or Intermittent Connection; Naturally Worn

  IT WAS REPORTED THAT, THREE 32 +4 TRIAL HEADS ARE WORN AND WILL NOT ARTICULATE WITH THE FEMORAL STEM SECURELY. NO CASE REPORTED; THEREFORE, THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11683513 ↗
• MalfunctionApr 18, 2021Loose or Intermittent Connection; Naturally Worn; Loose or Intermittent Connection; Naturally Worn

  IT WAS REPORTED THAT, THREE 32 +4 TRIAL HEADS ARE WORN AND WILL NOT ARTICULATE WITH THE FEMORAL STEM SECURELY. NO CASE REPORTED; THEREFORE, THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11683510 ↗
• MalfunctionApr 18, 2021Loose or Intermittent Connection; Naturally Worn; Loose or Intermittent Connection; Naturally Worn

  IT WAS REPORTED THAT, THREE 32 +4 TRIAL HEADS ARE WORN AND WILL NOT ARTICULATE WITH THE FEMORAL STEM SECURELY. NO CASE REPORTED; THEREFORE, THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11683509 ↗
• MalfunctionNov 28, 2019Break; Break

  IT WAS REPORTED THAT DURING SURGERY, A TAB IN THE TRIAL HEAD SNAPPED OFF, AND IT WOULD NOT STAY ON THE STEM. THERE WERE NO DELAYS IN THE PROCEDURE AND A BACKUP DEVICE WAS AVAILABLE. NO PATIENT INJURIES REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9390629 ↗
• MalfunctionJul 7, 2019Break; Break

  IT WAS REPORTED THAT DURING A THR PROCEDURE, PLASTIC PIECE ON BASE OF FEMORAL TRIAL SNAPPED OFF WHEN TRIALING HIP. ALL PIECES REMOVED AND RECOVERED FROM PATIENT. NO INJURY OR IMPACT TO PATIENT. NO DELAY. BACKUP DEVICE AVAILABLE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8766049 ↗
• MalfunctionJun 19, 2019Break; Break

  IT WAS REPORTED THAT THE ITEM BROKE DURING IMPACTION. NO INJURY REPORTED. SURGERY COMPLETED WITH A S&N BACKUP DEVICE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8713161 ↗

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