NA 71369717Recalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 03596010555632), received between Oct 22, 2020 and Oct 13, 2022 — classified as 5 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 5 most recent of 5 reports, in the reporter's own words as published by the FDA.

• MalfunctionOct 13, 2022Fracture; Fracture

  IT WAS REPORTED THAT A MI TRIAL FEM HEAD 32 +8 HAS ITS COLLAR BROKEN. AS THIS WAS NOTICED UPON FIELD INSPECTION, THERE WAS NOT PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15601592 ↗
• MalfunctionAug 25, 2021Break; Break

  IT WAS REPORTED THAT, DURING THE SET UP OR INSPECTION FOR A THR SURGERY, THE SKITS AROUND THE BASE OF TWO (2) TRIALS, A MI TRIAL FEM HEAD 32 +8 AND A MI TRIAL FEM HEAD 32 +16, WERE BROKEN. SURGERY WAS PERFORMED, WITHOUT ANY DELAY, WITH A BACK-UP DEVICE INSTEAD. AS THIS HAPPENED BEFORE USE IN PATIENT, THERE WERE NOT INJURIES AS CONSEQUENCE OF THIS PROBLEM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12363861 ↗
• MalfunctionJan 13, 2021Break; Break

  IT WAS REPORTED THAT DURING CLEANING AND STERILIZING, IT WAS FOUND THAT THE TRIAL HEAD WAS BROKEN. NO CASE INVOLVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11159867 ↗
• MalfunctionNov 13, 2020Break; Break

  IT WAS REPORTED THAT A MI TRIAL FEM HEAD 32 +8 WAS FOUND BROKEN DURING INSPECTION. NO CASE INVOLVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions; No Patient Involvement

  MAUDE report 10840614 ↗
• MalfunctionOct 22, 2020Break; Break

  IT WAS REPORTED THAT ONE OF THE TEETH ON MI TRIAL FEM HEAD 32 +8 BROKE OFF. NO CASE INVOLVED.

  Patient problems: No Patient Involvement

  MAUDE report 10719374 ↗

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