NA 71369721Recalls & reported problems

Summary

The FDA's MAUDE database contains 61 adverse event reports that list this exact device (DI 03596010559920), received between Feb 21, 2019 and Dec 15, 2025 — classified as 6 injuries, 55 malfunctions.

The most frequently reported specific device problem is “Break” (39 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 25 most recent of 61 reports, in the reporter's own words as published by the FDA.

• MalfunctionDec 15, 2025Fracture; Fracture

  IT WAS REPORTED THAT, DURING A THA SURGERY, ONE OF THE SMALL TABS OF ONE (1) MI TRIAL FEM HEAD 36 +0 BROKE OFF TRYING TO PUT THE TRIAL ON. THE PROCEDURE WAS PERFORMED, WITHOUT ANY DELAY, USING AN EQUIVALENT S+N BACK- UP. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23812782 ↗
• MalfunctionSep 24, 2025Fracture; Fracture

  IT WAS REPORTED THAT, DURING A THR SURGERY, IT WAS NOTICED THAT TWO OF THE TABS ON THE INSIDE ONE (1) MI TRIAL FEM HEAD 36 +0 SNAPPED OFF. NO PIECES FELL INSIDE THE PATIENT THE PROCEDURE WAS RESUMED, WITHOUT ANY SURGICAL DELAY, USING AN EQUIVALENT S+N BACK-UP. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23133255 ↗
• MalfunctionAug 14, 2025Break; Break

  IT WAS REPORTED THAT, DURING A THR SURGERY, THE TABS OF ONE (1) MI TRIAL FEM HEAD 36 +0, WHICH MAKE THE TRIAL FIT THE STEM, ARE BROKEN. THE PROCEDURE WAS RESUMED, WITHOUT ANY DELAY, USING THE SAME DEVICE. NO INJURY WAS REPORTED AS A CONSEQUENCE OF THIS ISSUE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22801577 ↗
• MalfunctionMar 21, 2025Fracture; Fracture

  IT WAS REPORTED THAT DURING A THR, THE PLASTIC ON A MI TRIAL FEM HEAD 36 +0 BROKE. ALL PIECES WERE REPORTEDLY RECOVERED WITH TWEEZERS AND SUCTION. THERE WAS NO DELAY AND THE PROCEDURE WAS FINISHED USING A SMITH & NEPHEW BACK UP. PATIENT WAS NOT HARMED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21663747 ↗
• MalfunctionJan 20, 2025Fracture; Fracture

  IT WAS REPORTED THAT, DURING THR SURGERY, THE INNER TAPER CONNECTION PIECE OF ONE (1) MI TRIAL FEM HEAD 36 +0 CHIPPED AND BROKE OFF. THE DEVICE WAS BROKEN INTERNALLY, BUT THE BROKEN PIECE WAS RETRIEVED AND CAPTURED. THE BROKEN PIECES WERE STILL INSIDE THE HEAD TRIAL WHEN REMOVED FROM THE PATIENT, THEN NO TWEEZERS OR SUCTION WAS REQUIRED. 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 21194214 ↗
• MalfunctionMar 27, 2024Fracture; Fracture

  IT WAS REPORTED THAT, DURING A THR SURGERY, THE INNER FLANGE ON ONE (1) MI TRIAL FEM HEAD 36 +0 BROKE AWAY, PREVENTING IT FROM PROPERLY SEATING ON THE FEMORAL STEM FOR TRIALING. 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 18987962 ↗
• MalfunctionMay 2, 2023Break; Fracture; Break; Fracture

  IT WAS REPORTED THAT, DURING A THR SURGERY, A MI TRIAL FEM HEAD 36 +0 BROKE DURING TRIALING. 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 16854462 ↗
• MalfunctionApr 18, 2023Fracture; Fracture

  IT WAS REPORTED THAT THE INNER TAPER PORTION OF MI TRIAL FEM HEAD 36 BROKE OFF WHILE TRIALING THE HEAD. NOTHING FELL INTO THE PATIENT. THE PROCEDURE WAS RESUMED, WITHOUT ANY DELAY, USING A S+N BACKUP DEVICE. THE PATIENT WAS NOT INJURED AS A CONSEQUENCE OF THIS PROBLEM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16765633 ↗
• MalfunctionApr 6, 2023Fracture; Fracture

  IT WAS REPORTED THAT, DURING THR SURGERY, A MI TRIAL FEM HEAD 36 +0 WAS SCRATCHED ON THE INSIDE, MAKING IT UNABLE TO BE USED WITH REAL STEM IMPLANT. SURGERY WAS RESUMED, AFTER A NON-SIGNIFICANT DELAY, WITH A S+N BACK-UP DEVICE. PATIENT WAS NOT INJURED AS CONSEQUENCE OF THIS PROBLEM. ADDITIONALLY, DURING DEVICE EVALUATION, IT WAS FOUND THAT TWO OF THE PLASTIC TABS ON THE INSIDE OF THE DEVICE ARE FRACTURED OFF.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16690472 ↗
• MalfunctionSep 13, 2022Fracture; Fracture

  IT WAS REPORTED THAT THE TAB OF THE MI TRIAL FEM HEAD 36 +0 BROKE OFF. AS THIS HAPPENED AFTER SURGERY. NO PATIENT WAS INVOLVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15415293 ↗
• MalfunctionAug 24, 2022Fracture; Fracture

  IT WAS REPORTED THAT DURING A THR, THE MI TRIAL FEM HEAD 36 +0 BROKE. SURGERY WAS RESUMED, WITHOUT ANY DELAY, WITH THE SAME DEVICE. PATIENT WAS NOT HARMED AS CONSEQUENCE OF THIS PROBLEM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15281977 ↗
• MalfunctionJul 27, 2022Fracture; Fracture

  IT WAS REPORTED THAT, THE NECK JUNCTION OF A MI TRIAL FEM HEAD 36 +0 IS BROKEN. AS THIS WAS NOTICED UPON FIELD INSPECTION, THERE WAS NOT PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15117453 ↗
• MalfunctionJul 20, 2022Fracture; Fracture

  IT WAS REPORTED THAT ONE (1) TRIAL FEMORAL HEAD 36 S/+0 BROKE OFF AND IS UNABLE TO RECEIVE THE NECK TRIAL. AS THIS WAS NOTICED UPON FIELD INSPECTION, NO PATIENT WAS INVOLVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15067039 ↗
• MalfunctionJul 13, 2022Fracture; Fracture

  IT WAS REPORTED THAT THE MI TRIAL FEM HEAD 36 +0 INNER SLEEVE HAS A BROKEN TAB. NO CASE INVOLVED; THEREFORE, THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15009029 ↗
• MalfunctionJun 22, 2022Break; Break

  IT WAS REPORTED THAT A MI TRIAL FEMORAL HEAD 36MM +0 IS BROKEN. 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 14777554 ↗
• MalfunctionJun 9, 2022Break; Break

  IT WAS REPORTED THAT THE INNER TAB OF A MI TRIAL FEMORAL HEAD 36MM +0 BROKE. AS THIS WAS NOTICED UPON INSPECTION, THERE WAS NOT PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14644931 ↗
• MalfunctionJun 8, 2022Break; Break

  IT WAS REPORTED THAT BOTH OXINIUM FEM HD 12/14 36 MM +0 HAVE PIECES BROKEN THAT KEEP THEM FROM SITTING ON THE NECK PROPERLY. SINCE IT WAS NOTICED DURING A FIELD INSPECTION, NO PATIENT WAS INVOLVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14629625 ↗
• MalfunctionMay 12, 2022Break; Break

  IT WAS REPORTED THAT ONE MI TRIAL FEM HEAD 36 -3, ONE MI TRIAL FEM HEAD 36 +0 AND ONE MI TRIAL FEM HEAD 32 +0 HAVE INNER FLANGES THAT HAVE BROKEN AWAY PREVENTING THE TRIAL HEAD FROM SEATING ON THE FEMORAL TRIAL/STEM. SURGICAL REPROCESSING HAS DISCARDED. NO CASE INVOLVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14378179 ↗
• MalfunctionMay 11, 2022Break; Break

  IT WAS REPORTED THAT TWO (2) MI TRIAL FEM HEAD 36 +0 TAB BROKEN. SINCE IT WAS NOTICED DURING A FIELD INSPECTION, NO PATIENT WAS INVOLVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14366170 ↗
• InjuryMay 4, 2022Fracture; Fracture

  IT WAS REPORTED THAT, DURING TOTAL HIP REPLACEMENT, THE LOCKING MECHANISM INSIDE AN MI TRIAL FEMORAL HEAD 36MM +0 WAS OBSERVED TO NOT STAY ON TO TRIAL COMPONENTS. INCIDENT OCCURRED INSIDE PATIENT. SURGERY WAS RESUMED, WITHOUT ANY DELAY, WITH A SMITH & NEPHEW BACK-UP DEVICE. PATIENT WAS NOT INJURED BEYOND THE REPORTED ISSUE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14282398 ↗
• MalfunctionApr 8, 2022Break; Break

  IT WAS REPORTED THAT A TAB INSIDE THE MI TRIAL FEM HEAD 36 +0 WAS FOUND TO BE BROKEN. SINCE IT WAS NOTICED DURING AN INSPECTION, NO PATIENT WAS INVOLVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14051244 ↗
• MalfunctionMar 31, 2022Break; Break

  IT WAS REPORTED THAT, DURING THR SURGERY, ONE OF INNER LOCKING TABS TO MI TRIAL FEM HEAD 36 +0 BROKE OFF DURING EXTRACTION FROM NECK. THE PROCEDURE WAS ABLE TO BE COMPLETED WITH THE SAME DEVICE. SURGERY WAS NOT DELAYED. PATIENT WAS NOT HARMED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13961731 ↗
• MalfunctionMar 24, 2022Fracture; Fracture

  IT WAS REPORTED THAT THE INNER TAB OF THE TRIAL FEMORAL HEAD 36 S/+0 WAS FOUND TO BE MISSING. AS THIS WAS NOTICED UPON FIELD INSPECTION, NO PATIENT WAS INVOLVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13878140 ↗
• InjuryMar 20, 2022Break; Break

  IT WAS REPORTED THAT DURING A THR SURGERY THE MI TRIAL FEM HEAD 36 +0 BROKE INSIDE THE PATIENT. ALL PIECES WERE REMOVED WITH TWEEZERS. THE PROCEDURE WAS COMPLETED, WITH A NON-SIGNIFICANT DELAY, USING A S+N BACK-UP DEVICE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13830062 ↗
• MalfunctionMar 10, 2022Break; Break

  IT WAS REPORTED THAT, THE MI TRIAL FEM HEAD 36 +0 WAS BROKEN. 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 13725136 ↗

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