NA 71353200Recalls & reported problems

Summary

The FDA's MAUDE database contains 8 adverse event reports that list this exact device (DI 03596010198280), received between Oct 7, 2019 and Nov 21, 2024 — classified as 8 malfunctions.

The most frequently reported specific device problem is “Break” (5 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 16, 2026.

Most reported problems

Recent adverse event reports

The 8 most recent of 8 reports, in the reporter's own words as published by the FDA.

• MalfunctionNov 21, 2024Fracture; Fracture

  IT WAS REPORTED THAT, DURING A THR SURGERY, THE INTERNAL TAB THAT SECURES ONE (1) TRL 12/14 TPR FEM HD 32 + 0 TO THE TAPER JUNCTION OF THE STEM BROKE OFF WHEN THE SURGEON WAS ATTEMPTING TO PUT IT ONTO THE FEMORAL IMPLANT. THE PROCEDURE WAS RESUMED AFTER A NON-SIGNIFICANT DELAY USING A SMITH AND NEPHEW BACKUP DEVICE, AND NO INJURIES WERE REPORTED AS A RESULT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20746921 ↗
• MalfunctionNov 20, 2024Break; Break

  IT WAS REPORTED THAT, DURING TRIAL INSERTION IN A THR SURGERY, THE INTERNAL TAB WITHIN ONE (1) TRL 12/14 TPR FEM HD 32 + 0, THAT HELPS SECURE IT TO THE 12/14 TAPER, BROKE. THE PROCEDURE WAS RESUMED AFTER A NON-SIGNIFICANT DELAY USING A SMITH AND NEPHEW BACKUP DEVICE, AND NO INJURIES WERE REPORTED AS A RESULT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20733956 ↗
• MalfunctionAug 22, 2022Break; Break

  IT WAS REPORTED THAT THE TABS OF THE TRL 12/14 TPR FEM HD 32 + 0 WERE FOUND TO BE BROKEN OFF. NO CASE WAS REPORTED; THEREFORE, THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15266795 ↗
• MalfunctionMar 28, 2022Crack; Crack

  IT WAS REPORTED THAT DURING ROUTINE INSPECTION AND CLEANING, IT WAS FOUND THAT SIXTEEN (16) TRL 12/14 TPR FEM HD 32 + 0 HAVE CRACKED WHITE RETAINING RINGS, SOME WITH RETAINED DEBRIS. NO CASE INVOLVED; THEREFORE, THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13927421 ↗
• MalfunctionJun 22, 2021Scratched Material; Scratched Material

  IT WAS REPORTED THAT A TRIAL 12/14 TAPER FEMORAL HEAD 32MM + 0 AND A TRL 12/14 TPR FEM HD 32 + 4 WERE CHIPPED. AS THIS WAS NOTICED UPON INSPECTION, THERE WAS NOT PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12043000 ↗
• MalfunctionApr 19, 2021Break; Break

  IT WAS REPORTED THAT, WHILE DOING INSTRUMENT INSPECTIONS, IT WAS NOTICED THAT ONE OF THE PRONGS OF THE TRL 12/14 TPR FEM HD 32 + 0 WAS BROKEN. NO CASE REPORTED; THEREFORE, THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11683740 ↗
• MalfunctionMar 30, 2021Break; Break

  IT WAS REPORTED THAT, WHILE DOING INSTRUMENT INSPECTIONS, IT WAS NOTICED THAT ONE OF THE PRONGS OF THE TRL 12/14 TPR FEM HD 32 + 0 WAS BROKEN. NO CASE REPORTED; THEREFORE, THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11593384 ↗
• MalfunctionOct 7, 2019Break; Break

  IT WAS REPORTED THAT THE PLASTIC PART OF THE INNER HEAD COLLAPSED DURING TRIAL. THERE WAS NO DELAY NOR PATIENT INJURY INVOLVED. NO FURTHER INFORMATION AVAILABLE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9163287 ↗

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