NA 71353203Recalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 03596010198297), received between Oct 22, 2019 and Nov 20, 2025 — classified as 2 injuries, 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. How this data works · Data updated Oct 13, 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.

• MalfunctionNov 20, 2025Fracture; Fracture

  IT WAS REPORTED THAT DURING A THA SURGERY, WHILE TRIALING, ONE OF THE TABS ON THE INSIDE OF THE TRL 12/14 TPR FEM HD 32 -3 CRACKED OFF, DID NOT FALL INSIDE PATIENT. THE PROCEDURE WAS RESUMED, WITHOUT ANY DELAY, USING A S+N BACK-UP DEVICE. PATIENT WAS NOT INJURED AS CONSEQUENCE OF THIS PROBLEM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23607297 ↗
• InjuryOct 12, 2022Fracture; Fracture

  IT WAS REPORTED THAT, DURING THR, THE INNER TAB IN ONE (1) TRL 12/14 TPR FEM HD 32 -3, BROKE OFF WHILE TRIALING. THE DEVICE DID BREAK INSIDE THE PATIENT, THE PIECE WAS VISUALIZED AND RETRIEVED WITH A SNAP. SURGERY WAS PERFORMED, WITHOUT ANY DELAY, WITH A BACK-UP DEVICE INSTEAD. NO OTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15591336 ↗
• MalfunctionAug 22, 2022Break; Break

  IT WAS REPORTED THAT THE TABS OF THE TRL 12/14 TPR FEM HD 32 -3 WAS 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 15266752 ↗
• InjuryMar 5, 2020Break; Break

  IT WAS REPORTED THAT DURING A THA PROCEDURE, FLANGE THAT APPROXIMATES WITH TRUNNION ON FEMORAL STEM BROKE OFF. THE TRIAL HEAD DOES NOT FIT SECURELY WITHOUT THIS PLASTIC FLANGE. LENGTH OF DELAY UNKNOWN. S&N BACKUP DEVICE AVAILABLE. NO IMPACT OR INJURY TO PATIENT REPORTED.

  Patient problems: Injury

  MAUDE report 9792467 ↗
• MalfunctionOct 22, 2019Break; Break

  IT WAS REPORTED THAT TWO PIECES OF INNER COLLAR BROKE OFF. OCCURRED INSIDE OF PATIENT, ALL PIECES WERE RECOVERED. S&N BACKUP DEVICE WAS AVAILABLE AND WAS USED TO COMPLETE THE SURGERY. NO PATIENT AFFECTATION, NO PICTURES AVAILABLE, NO CLOSURE LETTER NEEDED, LOT NUMBER IS NOT ON ITEM.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9220414 ↗

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