NA 71369720Recalls & reported problems

Summary

The FDA's MAUDE database contains 23 adverse event reports that list this exact device (DI 03596010559913), received between Oct 1, 2020 and Jun 4, 2024 — classified as 1 injury, 22 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 23 most recent of 23 reports, in the reporter's own words as published by the FDA.

• MalfunctionJun 4, 2024Degraded; Fracture; Material Fragmentation; Deformation Due to Compressive Stress; Degraded; Fracture; Material Fragmentation; Deformation Due to Compressive Stress

  IT WAS REPORTED THAT, DURING A TKA, IT WAS NOTICED THAT ONE (1) MI TRIAL FEM HEAD 36 -3 WAS WORN AND THE PLASTIC WAS BREAKING OFF. THE PROCEDURE WAS RESUMED, WITHOUT ANY DELAY, USING A S+N BACK-UP DEVICE. PATIENT WAS NOT HARMED AS A CONSEQUENCE OF THIS PROBLEM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19463172 ↗
• MalfunctionJun 9, 2023Fracture; Fracture

  IT WAS REPORTED THAT DURING SURGERY, ONE (X1) MI TRIAL FEM HEAD 36 -3 BROKE INTERNALLY TO THE PATIENT. THE PIECES WERE RETRIEVED FROM THE PATIENT WITH FORCEPS. THE PROCEDURE WAS COMPLETED WITHOUT DELAY USING A S+N BACKUP DEVICE. NO INJURY WAS REPORTED AS A CONSEQUENCE OF THIS ISSUE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17095845 ↗
• MalfunctionNov 5, 2022Break; Break

  IT WAS REPORTED THAT THE INNER TAB OF THE MI TRIAL FEM HEAD 36 -3 BROKE OFF. FOUND BROKEN IN CENTRAL SERVICES WHEN ASSEMBLING TRAYS. NO CASE REPORTED; THEREFORE, THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15740875 ↗
• MalfunctionJul 20, 2022Fracture; Fracture

  IT WAS REPORTED THAT ONE (1) TRIAL FEMORAL HEAD 36 XS/-3 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 15067157 ↗
• MalfunctionJul 11, 2022Break; Break

  IT WAS REPORTED THAT, THE INNER FLANGES OF THE MI TRIAL FEM HEAD 36 -3 HAS BROKEN AWAY AND TRAIL HEAD WILL NOT SEAT ON STEM. NO CASE REPORTED; THEREFORE, THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14974324 ↗
• 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 14379612 ↗
• MalfunctionMar 20, 2022Crack; Positioning Failure; Crack; Positioning Failure

  IT WAS REPORTED THAT AN MI TRIAL FEMORAL HEAD 36M -3 HAD AN INNER FLANGE THAT HAD CRACKED AND WOULD NOT SEAT ON THE TRIAL FEMORAL STEM SECURELY. AS THIS WAS NOTICED IN A NON-SURGICAL ENVIRONMENT, THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13831431 ↗
• MalfunctionJan 26, 2022Break; Break

  IT WAS REPORTED THAT, AFTER A THR SURGERY, THE INNER FLANGE OF A MI TRIAL FEM HEAD 36 -3 BROKE AWAY AND THE HEAD WILL NOT SEAT ON THE FEMORAL STEM DURING TRAILING. AS THIS WAS NOTICED AFTER USE IN PATIENT, SURGERY WAS FINISHED WITH THE SAME DEVICE, WITHOUT ANY DELAY. NO HARM TO THE PATIENT REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13362294 ↗
• MalfunctionDec 29, 2021Break; Break

  IT WAS REPORTED THAT, THE TAP OF A MI TRIAL FEM HEAD 36 -3 WAS BROKEN. AS THIS WAS NOTICED UPON FIELD INSPECTION, THERE WAS NOT PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13114612 ↗
• MalfunctionDec 21, 2021Break; Break

  IT WAS REPORTED THAT, A MI TRIAL FEM HEAD 36 -3 WAS FOUND BROKEN, RENDERING IT UNUSABLE. NO CASE REPORTED; THEREFORE, THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13055090 ↗
• MalfunctionDec 20, 2021Break; Break

  IT WAS REPORTED THAT THE INSIDE TABS OF MI TRIAL FEM HEAD 36 -3 LOCK BROKEN OFF. NO CASE INVOLVED; THEREFORE, NO OTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13043406 ↗
• MalfunctionSep 15, 2021Break; Break

  IT WAS REPORTED THAT ONE (1) MI TRIAL FEMORAL HEAD 36MM -3 AND ONE (1) MI TRIAL FEMORAL HEAD 36MM + 0 HAVE THE INSIDE BROKEN OFF. IN ADDITION, TWO (2) EASY PLASTIC TRAY LIDS ARE CRACKED. AS THIS WAS NOTICED UPON FIELD INSPECTION, THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12474687 ↗
• MalfunctionJul 15, 2021Break; Break

  IT WAS REPORTED THAT, DURING THR, A MI TRIAL FEM HEAD 36 -3 HAD BROKEN TABS. THIS HAPPENED BEFORE USE IN PATIENT. SURGERY WAS PERFORMED, WITHOUT ANY DELAY, WITH A BACK-UP DEVICE INSTEAD. PATIENT WAS NOT INJURED AS CONSEQUENCE OF THIS PROBLEM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12173245 ↗
• MalfunctionJul 5, 2021Break; Break

  IT WAS REPORTED THAT TWO (2) MI TRIAL FEM HEAD 36 -3 HAVE THE INNER FLANGE BROKEN OFF AND WILL NOT SEAT ON THE FEMORAL STEM. 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 12114804 ↗
• MalfunctionJul 5, 2021Break; Break

  IT WAS REPORTED THAT TWO (2) MI TRIAL FEM HEAD 36 -3 HAVE THE INNER FLANGE BROKEN OFF AND WILL NOT SEAT ON THE FEMORAL STEM. 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 12114803 ↗
• InjuryMay 19, 2021Break; Break

  IT WAS REPORTED THAT, DURING A THR SURGERY WHILE THE INSTRUMENT WAS INSIDE OF THE PATIENT, THE MI TRIAL FEM HEAD 36 -3 WAS BROKE DURING SURGEON'S ATTEMPT TO ATTACH TRIAL HEAD TO TRIAL NECK PRIOR TO THE TRIAL REDUCTION STEP. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITHOUT DELAY USING THE SAME DEVICE. PATIENT WAS NOT HARMED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11849965 ↗
• MalfunctionApr 19, 2021Connection Problem; Material Deformation; Connection Problem; Material Deformation

  IT WAS REPORTED THAT SURGICAL REPROCESSING TEAM NOTICED THAT 3 OF THE MI TRIALS FEMORAL HEAD 36 -3 ARE WORN AND WOULD NOT ARTICULATE WITH THE FEMORAL STEM SECURELY. THERE WAS NO CASE INVOLVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11683735 ↗
• MalfunctionApr 19, 2021Connection Problem; Material Deformation; Connection Problem; Material Deformation

  IT WAS REPORTED THAT SURGICAL REPROCESSING TEAM NOTICED THAT 3 OF THE MI TRIALS FEMORAL HEAD 36 -3 ARE WORN AND WOULD NOT ARTICULATE WITH THE FEMORAL STEM SECURELY. THERE WAS NO CASE INVOLVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11683731 ↗
• MalfunctionApr 18, 2021Connection Problem; Material Deformation; Connection Problem; Material Deformation

  IT WAS REPORTED THAT SURGICAL REPROCESSING TEAM NOTICED THAT 3 OF THE MI TRIALS FEMORAL HEAD 36 -3 ARE WORN AND WOULD NOT ARTICULATE WITH THE FEMORAL STEM SECURELY. THERE WAS NO CASE INVOLVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11683583 ↗
• MalfunctionMar 8, 2021Fracture; Fracture

  IT WAS REPORTED THAT THE TRIAL BALL HEAD 36 S/+0 CONE WAS NOTICED TO BE CRACKED IN CLEANING. NO PATIENT OR SURGERY INVOLVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11430911 ↗
• MalfunctionJan 6, 2021Break; Break

  IT WAS REPORTED THAT, AFTER A THR, IT WAS NOTICED THAT THE LOCKING TAPER TAB OF A MI TRIAL FEM HEAD 36 -3 BROKE OFF DURING USE. PROCEDURE HAD BEEN FINISHED WITH SAME DEVICE. PATIENT WAS NOT HARMED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11124713 ↗
• MalfunctionJan 4, 2021Break; Break

  IT WAS REPORTED THAT THE INNER FLANGE FROM THE MI TRIAL FEMORAL HEAD 36 -3 HAS BROKEN OFF, NOT ALLOWING THE TRIAL HEAD TO SEAT ON THE UNION OF THE FEMORAL STEM/BROACH. 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

  MAUDE report 11113341 ↗
• MalfunctionOct 1, 2020Material Fragmentation; Material Fragmentation

  IT WAS REPORTED THAT THE MECHANISM WHICH HOLDS THE HEAD TO THE TRIAL NECK BROKE OFF, RENDERING THE HEAD UNUSABLE. AS NOTICED IN THE MDRD, NO CASE WAS INVOLVED.

  Patient problems: No Patient Involvement

  MAUDE report 10614185 ↗

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