NA 71353600Recalls & reported problems

Summary

The FDA's MAUDE database contains 19 adverse event reports that list this exact device (DI 03596010479716), received between Sep 24, 2020 and Dec 26, 2023 — classified as 5 injuries, 14 malfunctions.

The most frequently reported specific device problem is “Break” (14 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 19 most recent of 19 reports, in the reporter's own words as published by the FDA.

• MalfunctionDec 26, 2023Fracture; Fracture

  IT WAS REPORTED THAT, DURING THR SURGERY, THE INSIDE THAT CONNECTS WITH THE TRIAL 12/14 FEM HEAD 36MM +0 HAD A PIECE THAT BROKE. ALL PIECES OF THE TRIAL HEAD WERE RETRIEVED FROM THE PATIENT. THE PROCEDURE WAS RESUMED, WITHOUT ANY DELAY, USING A S+N BACK-UP DEVICE. NO INJURY WAS REPORTED AS A CONSEQUENCE OF THIS ISSUE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18392476 ↗
• MalfunctionDec 26, 2022Fracture; Fracture

  IT WAS REPORTED THAT, DURING A THR SURGERY, THE TRIAL 12/14 FEMORAL HEAD 36MM +0 BROKE. IT IS UNKNOWN IF PIECES FELL INTO THE 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 16048326 ↗
• MalfunctionNov 29, 2022Fracture; Fracture

  IT WAS REPORTED THAT, DURING A THR, THE INSIDE OF A TRIAL 12/14 FEM HEAD 36MM +0 THAT LATCHES ONTO THE STEM TRIAL WAS BROKEN. ADDITIONALLY, NO PIECES FELL INTO THE PATIENT. SURGERY WAS RESUMED, WITHOUT ANY DELAY, WITH A BACKUP DEVICE. THE PATIENT WAS NOT HARMED AS A CONSEQUENCE OF THIS PROBLEM. 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

  MAUDE report 15875765 ↗
• MalfunctionMay 11, 2022Break; Fracture; Break; Fracture

  IT WAS REPORTED THAT, DURING A THR PROCEDURE, THE INNER TRIAL 12/14 FEM HEAD 36 MM +0 LOCKING PART BROKE. NO PIECES FELL INTO PATIENT. SURGERY WAS RESUMED, WITHOUT ANY DELAY, WITH A SMITH AND NEPHEW BACK-UP DEVICE. PATIENT WAS NOT HARMED. NO FURTHER COMPLICATIONS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14352613 ↗
• MalfunctionMay 4, 2022Break; Break

  IT WAS REPORTED THAT, DURING THR SURGERY, A TRIAL 12/14 FEM HEAD 36MM +0 BROKE. NO PIECES FELL INTO PATIENT. SURGERY WAS FINISHED WITHOUT ANY DELAY, WITH A SN BACK-UP DEVICE. NO HARM TO THE PATIENT OR FURTHER COMPLICATIONS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14283278 ↗
• MalfunctionMar 28, 2022Crack; Crack

  IT WAS REPORTED THAT DURING ROUTINE INSPECTION AND CLEANING, IT WAS FOUND THAT TWELVE (12) TRIAL 12/14 FEM HEAD 36MM +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 13927408 ↗
• MalfunctionDec 22, 2021Break; Break

  IT WAS REPORTED THAT DURING A THR, THE TAB OF A TRIAL 12/14 FEM HEAD 36MM +0 BROKE OUTSIDE THE PATIENT. BROKEN PIECES WERE RECOVERED. THERE WAS NO DELAY AND THE PROCEDURE WAS FINISHED USING A SMITH & NEPHEW BACK UP DEVICE. PATIENT WAS NOT HARMED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13063878 ↗
• MalfunctionNov 15, 2021Break; Detachment of Device or Device Component; Break; Detachment of Device or Device Component

  IT WAS REPORTED THAT, THE LOCKING MECHANISM OF A TRIAL 12/14 FEM HEAD 36MM +0 IS BROKEN AND WILL NOT STAY ATTACHED TO THE STEM WHEN REDUCING THE HIP. AS THIS WAS NOTICED IN A NON-SURGICAL ENVIRONMENT, THERE WAS NOT ANY PATIENT INVOLVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12813961 ↗
• MalfunctionNov 3, 2021Break; Break

  IT WAS REPORTED THAT, DURING A THR SURGERY, THE RING OF A TRIAL 12/14 FEM HEAD 36MM +0 BROKE OFF. SURGERY WAS RESUMED, WITHOUT ANY DELAY, WITH A BACK-UP DEVICE. PATIENT WAS NOT INJURED AS CONSEQUENCE OF THIS PROBLEM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12745130 ↗
• MalfunctionAug 6, 2021Crack; Crack

  IT WAS REPORTED THAT, AFTER THR SURGERY, IT WAS NOTICED THAT A TRIAL 12/14 FEM HEAD 36MM +0 WAS CRACKED ON THE UNDERSIDE OF IT. SURGERY HAD BEEN COMPLETED WITHOUT ANY DELAY. PATIENT WAS NOT HARMED AS CONSEQUENCE OF THIS PROBLEM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12291490 ↗
• InjuryMay 19, 2021Break; Break

  IT WAS REPORTED THAT, DURING A THR SURGERY, WHEN THE INSTRUMENT WAS INSIDE OF THE PATIENT, THE TRIAL 12/14 FEM HEAD 36MM +0 BROKE. ALL THE BROKEN PIECES WERE RETRIEVED WITH A HEMOSTAT. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITH NO SIGNIFICANT DELAY USING A SMITH AND NEPHEW BACK UP DEVICE. PATIENT WAS NOT HARMED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11849862 ↗
• InjuryMay 19, 2021Break; Break

  IT WAS REPORTED THAT, DURING A THR SURGERY, FOUR (4) TRIAL 12/14 FEM HEAD 36 MM +0 BROKE. DEVICE INSIDE THE PATIENT. THE PROCEDURE WAS COMPLETED USING A S+N BACK-UP DEVICE. IT IS UNKNOWN IF THERE WAS ANY SURGICAL DELAY. PATIENT WAS NOT HARMED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11848857 ↗
• InjuryMay 19, 2021Break; Break

  IT WAS REPORTED THAT, DURING A THR SURGERY, FOUR (4) TRIAL 12/14 FEM HEAD 36MM +0 BROKE. DEVICE INSIDE THE PATIENT. THE PROCEDURE WAS COMPLETED USING A S+N BACK-UP DEVICE. IT IS UNKNOWN IF THERE WAS ANY SURGICAL DELAY. PATIENT WAS NOT HARMED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11848842 ↗
• InjuryMay 19, 2021Break; Break

  IT WAS REPORTED THAT, DURING A THR SURGERY, FOUR (4) TRIAL 12/14 FEM HEAD 36MM +0 BROKE. DEVICE INSIDE THE PATIENT. THE PROCEDURE WAS COMPLETED USING A S+N BACK-UP DEVICE. IT IS UNKNOWN IF THERE WAS ANY SURGICAL DELAY. PATIENT WAS NOT HARMED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11848816 ↗
• InjuryMay 19, 2021Break; Break

  IT WAS REPORTED THAT, DURING A THR SURGERY, FOUR (4) TRIAL 12/14 FEM HEAD 36 MM +0 BROKE. DEVICE INSIDE THE PATIENT. THE PROCEDURE WAS COMPLETED USING A S+N BACK-UP DEVICE. IT IS UNKNOWN IF THERE WAS ANY SURGICAL DELAY.PATIENT WAS NOT HARMED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11848778 ↗
• MalfunctionApr 11, 2021Break; Break

  IT WAS REPORTED THAT DURING EFIP INSPECTION, THE FOLLOWING ITEMS WERE FOUND DEFECTIVE: THE HANDLE AND THE TIP OF THE R3 DEPTH GAUGE ARE BENT (CASE (B)(4)), THE R3 IMPACTOR TIP HAS SCRATCHES (CASE (B)(4)), THE R3 LNR MPACTOR HD II 28MM HAS GOUGES ON THE HEAD (CASE (B)(4)), THE TRL 12/14 TPR FEM HD 32 + 8 HAS DISCOLORATION (CASE (B)(4)), THE TRIAL 12/14 FEM HEAD 36MM +0 IS BROKEN (CASE (B)(4)) AND THE TRIAL 12/14 FEM HEAD 36MM -3 HAS SCRATCHES (CASE (B)(4)). NO CASE OR PATIENT WAS INVOLVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11646906 ↗
• MalfunctionFeb 15, 2021Break; Break

  IT WAS FOUND DURING THE INSPECTION THAT THE HEAD OF THE TRIAL WAS BROKEN. NO CASE INVOLVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11326343 ↗
• MalfunctionSep 24, 2020Break; Break

  IT WAS REPORTED THAT THE PLASTIC FLANGES THAT CAPTURE THE NECK TRIAL WAS CRACKED OFF. NO CASE OR PATIENT INVOLVED. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED. IF ADDITIONAL INFORMATION SHOULD BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED ACCORDINGLY.

  Patient problems: No Patient Involvement

  MAUDE report 10583742 ↗
• MalfunctionSep 24, 2020Break; Break

  IT WAS REPORTED THAT THE PLASTIC FLANGES THAT CAPTURE THE NECK TRIAL WAS CRACKED OFF. NO CASE OR PATIENT INVOLVED. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED. IF ADDITIONAL INFORMATION SHOULD BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED ACCORDINGLY.

  Patient problems: No Patient Involvement

  MAUDE report 10583711 ↗

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