NA 71369723Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 03596010559944), received between Aug 7, 2020 and Aug 14, 2025 — classified as 1 injury, 3 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. 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 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• MalfunctionAug 14, 2025Break; Break

  IT WAS REPORTED THAT, DURING A THR SURGERY, THE TABS OF ONE (1) MI TRIAL FEM HEAD 36 +8, WHICH MAKE THE TRIAL FIT TO THE STEM, ARE BROKEN. THE PROCEDURE WAS RESUMED, WITHOUT ANY DELAY, USING THE SAME DEVICE. NO INJURY WAS REPORTED AS A CONSEQUENCE OF THIS ISSUE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22801572 ↗
• MalfunctionSep 29, 2021Crack; Naturally Worn; Crack; Naturally Worn

  IT WAS REPORTED THAT A FEMORAL HEAD IMPACTOR TIP IS BROKEN AND MISSING, FIVE (5) MI TRIAL FEM HEAD TRIALS ARE CRACKED AND WORN, AND AN ANTHOLOGY STD BROACH IS DULL AND WORN. AS THIS WAS NOTICED UPON FIELD INSPECTION, THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12546005 ↗
• MalfunctionSep 28, 2021Break; Break

  IT WAS REPORTED THAT AN MI TRIAL FEMORAL HEAD 36 MM +8 HAS A BROKEN TAB. AS THIS WAS NOTICED UPON FIELD INSPECTION, THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12539870 ↗
• InjuryAug 7, 2020Break; Break

  IT WAS REPORTED THAT, DURING SURGERY, PLASTIC FLANGE OF A MITRIAL FEM HEAD 36 +8 BROKE OFF WHILE INSIDE THE PATIENT AND ALL PIECES WERE RECOVERED. THE PROCEDURE HAD CONCLUDED WITH THE SAME DEVICE. SURGERY WAS NOT DELAYED. THE PATIENT WAS NOT HARMED BEYOND WHAT HAS BEEN DESCRIBED HERE.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 10379747 ↗

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