NA 71366516Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00885556110126), received between Aug 23, 2018 and Apr 5, 2021 — classified as 2 malfunctions.

The most frequently reported specific device problem is “Break” (1 report).

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 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• MalfunctionApr 5, 2021Break; Break

  IT WAS REPORTED THAT, THERE WAS A EFIP INSPECTION FAILURE ON THE FEMORAL HEAD TRIAL 12/14 40 -4. IT IN UNKNOWN HOW THE DEVICE FAILED. NO CASE REPORTED; THEREFORE, THERE WAS NO PATIENT INVOLVEMENT. THE INVESTIGATION FOUND THAT THE DEVICE IS BROKEN, WHICH MAKES IT A REPORTABLE EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11612169 ↗
• MalfunctionAug 23, 2018Device Damaged by Another Device; Device Damaged by Another Device

  IT WAS REPORTED A MALFUNCTION IN WHICH THE INSIDE OF TRIAL HEAD (40MM -4) CLIP THAT LOCKS INTO 12/14 TAPER ON FEMORAL TRIAL NECK BROKE OFF. THE BROKEN PART WAS RETRIEVED FROM THE PATIENT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7808533 ↗

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