NA 71366518Recalls & reported problems

Summary

The FDA's MAUDE database contains 7 adverse event reports that list this exact device (DI 00885556110102), received between Nov 18, 2020 and Oct 16, 2025 — classified as 1 injury, 6 malfunctions.

The most frequently reported specific device problem is “Break” (6 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 7 most recent of 7 reports, in the reporter's own words as published by the FDA.

• MalfunctionOct 16, 2025Fracture; Fracture

  IT WAS REPORTED THAT DURING A THR SURGERY, WHEN REMOVING ONE (1) FEMORAL HEAD TRIAL 12/14 40 +4 AFTER TRIALING, ONE OF THE INTERNAL TABS BROKE OFF. ALL PIECES WERE REMOVED FROM WOUND AND VERIFIED ALL FRAGMENTS WERE RETRIEVED. THE PROCEDURE WAS COMPLETED WITH A SIMILAR S+N BACKUP PRODUCT. NO INJURY WAS REPORTED AS A CONSEQUENCE OF THIS ISSUE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23310862 ↗
• InjuryNov 22, 2021Break; Break

  IT WAS REPORTED THAT, DURING A THR SURGERY, A FEMORAL HEAD TRIAL 12/14 TAPER40 +4 BROKE. A PLASTIC PIECE OF THE HEAD TRIAL WAS FOUND IN THE SURGICAL FIELD. SURGERY WAS PERFORMED, AFTER A NON-SIGNIFICANT DELAY, WITH THE SAME DEVICE. PATIENT WAS NOT HARMED AS CONSEQUENCE OF THIS PROBLEM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12852572 ↗
• MalfunctionApr 20, 2021Break; Break

  IT WAS REPORTED THAT DURING INSPECTION THE INTERNAL CAPTURE PIECE OF THE FEMORAL HEAD TRIAL 12/14 40 +4 SNAPPED OFF. NO CASE INVOLVED THEREFORE NO PATIENT IMPACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11693321 ↗
• MalfunctionMar 29, 2021Break; Break

  IT WAS REPORTED THAT DURING INSPECTION THE FEMORAL HEAD TRIAL 12/14 40 +4 WAS FOUND TO BE BROKEN. NO CASE INVOLVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11586729 ↗
• MalfunctionJan 6, 2021Break; Break

  IT WAS REPORTED THAT DURING AN EFIP INSPECTION, THE FEMORAL HEAD TRIAL 12/14 40 +4 WAS FOUND BROKEN.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11123453 ↗
• MalfunctionDec 9, 2020Break; Break

  IT WAS REPORTED THAT DURING INSPECTION, THE FEMORAL HEAD TRIAL 12/14 40 +4 WAS NOTICED TO BE CHIPPED. NO CASE INVOLVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 10976354 ↗
• MalfunctionNov 18, 2020Break; Break

  IT WAS REPORTED THAT THE FEMORAL HEAD TRIAL 12/14 40 +4 IS CRACKED AND BEGINNING TO BREAK APART. NO CASE INVOLVED. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED. IF ADDITIONAL INFORMATION SHOULD BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED ACCORDINGLY.

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

  MAUDE report 10862740 ↗

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