NA 71366519Recalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 00885556110096), received between May 5, 2020 and May 9, 2025 — 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. 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 5 most recent of 5 reports, in the reporter's own words as published by the FDA.

• MalfunctionMay 9, 2025Material Fragmentation; Material Fragmentation

  IT WAS REPORTED THAT DURING A THR, THE FEMORAL HEAD TRIAL 12/14 40 + CHIPPED. NO PIECES FELL INSIDE PATIENT. SURGERY WAS PERFORMED, WITHOUT ANY DELAY, WITH A BACK-UP DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21995442 ↗
• MalfunctionApr 5, 2022Break; Break

  IT WAS REPORTED THAT A FEMORAL HEAD TRIAL 12/14 40 +8 WAS FOUND BROKEN. AS THIS WAS NOTICE IN A FIELD INSPECTION, NOT PATIENT WAS INVOLVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14018477 ↗
• MalfunctionOct 5, 2021Break; Break

  IT WAS REPORTED THAT, 2 OF 4 CLIPS OF A FEMORAL HEAD TRIAL 12/14 40 +8 ON BOTTOM WERE BROKEN. AS THIS WAS NOTICED UPON FIELD INSPECTION, THERE WAS NOT PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12579786 ↗
• MalfunctionJun 3, 2021Break; Break

  IT WAS REPORTED THAT, DURING FIELD INSPECTION, THE FEMORAL HEAD TRIAL 12/14 40 +8 WAS FOUND TO BE BROKEN. NO CASE REPORTED; THEREFORE, THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11934928 ↗
• MalfunctionMay 5, 2020Break; Break

  IT WAS REPORTED THAT DURING INSPECTION THE DEVICE WAS FOUND WITH BROKEN TABS AND WOULD NOT LOCK ON THE FEMORAL NECK TRIAL PROPERLY. NO INJURY OR HARM WAS REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10025479 ↗

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