NA 71369714Recalls & reported problems

Summary

The FDA's MAUDE database contains 16 adverse event reports that list this exact device (DI 03596010555601), received between Sep 24, 2019 and Jul 11, 2022 — classified as 1 injury, 15 malfunctions.

The most frequently reported specific device problem is “Break” (9 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 16 most recent of 16 reports, in the reporter's own words as published by the FDA.

• MalfunctionJul 11, 2022Break; Break

  IT WAS REPORTED THAT, THE INNER FLANGES OF THE MI TRIAL FEM HEAD 32 -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 14974314 ↗
• MalfunctionJul 6, 2022Fracture; Fracture

  IT WAS REPORTED THAT, DURING THR SURGERY, A MI TRIAL FEM HEAD 32 -3 BROKE AND COULD NOT SIT PROPERLY ON THE STEM. IT IS UNKNOWN IF PIECES FELL INTO THE PATIENT. THE PROCEDURE WAS COMPLETED WITHOUT DELAY USING A S+N BACK-UP DEVICE. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14940311 ↗
• MalfunctionApr 28, 2022Material Fragmentation; Material Fragmentation

  IT WAS REPORTED THAT CHIPPED PIECES WERE OBSERVED ON A MI TRIAL FEMORAL HEAD 32MM -3. AS THIS WAS NOTICED UPON CLEANING AND STERILIZATION ACTIVITIES, THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14231964 ↗
• MalfunctionDec 28, 2021Break; Break

  IT WAS REPORTED THAT, DURING FIELD INSPECTION, IT WAS FOUND THAT THE BOTTOM PIECE OF A MI TRIAL FEM HEAD 36 +0, A MI TRIAL FEM HEAD 32 -3 AND A MI TRIAL FEM HEAD 32 +4 IS BROKEN SO THE NECK TRIALS CANNOT STAY ATTACHED TO THEM (CASE: (B)(4)). NO CASE INVOLVED; THEREFORE, THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13094858 ↗
• MalfunctionJun 10, 2021Break; Break

  IT WAS REPORTED THAT THE KIT NO. 008310-004-S002 HAD THE MI TRIAL FEM HEAD 28 -3 (B)(4) WORN OUT AT THE BOTTOM, AND ONE OF THE PLASTIC TEETH ON THE INSIDE OF THE MI TRIAL FEM HEAD 32 -3 (B)(4) HAD BROKEN OFF. AS THIS WAS NOTICED UPON FIELD INSPECTION, NO PATIENT WAS INVOLVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11977950 ↗
• MalfunctionApr 21, 2021Fracture; Naturally Worn; Fracture; Naturally Worn

  IT WAS REPORTED THAT THE TRIAL FEMORAL HEAD 32 XS/-3 IS WORN AND HAS A SMALL CHIP ON IT. NO CASE OR PATIENT INVOLVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11704468 ↗
• MalfunctionApr 18, 2021Connection Problem; Naturally Worn; Connection Problem; Naturally Worn

  IT WAS REPORTED THAT, THREE 32 -3 TRIAL HEADS ARE WORN AND WILL NOT ARTICULATE WITH THE FEMORAL STEM SECURELY. NO CASE REPORTED; THEREFORE, THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11683591 ↗
• MalfunctionApr 18, 2021Connection Problem; Naturally Worn; Connection Problem; Naturally Worn

  IT WAS REPORTED THAT, THREE 32 -3 TRIAL HEADS ARE WORN AND WILL NOT ARTICULATE WITH THE FEMORAL STEM SECURELY. NO CASE REPORTED; THEREFORE, THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11683590 ↗
• MalfunctionApr 18, 2021Connection Problem; Naturally Worn; Connection Problem; Naturally Worn

  IT WAS REPORTED THAT, THREE 32 -3 TRIAL HEADS ARE WORN AND WILL NOT ARTICULATE WITH THE FEMORAL STEM SECURELY. NO CASE REPORTED; THEREFORE, THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11683585 ↗
• MalfunctionMar 22, 2021Break; Connection Problem; Break; Connection Problem

  IT WAS REPORTED THAT, DURING SET UP OR INSPECTION BEFORE A THR THE INNER FLANGE HAS BROKEN AWAY AND THE MI TRIAL FEM HEAD 32 -3 WILL NOT SEAT ON THE FEMORAL STEM DURING TRIALING. INCIDENT OCCURRED BEFORE THE PROCEDURE; THEREFORE, THERE WAS NO PATIENT INVOLVEMENT. 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 11540711 ↗
• MalfunctionDec 31, 2020Break; Break

  IT WAS REPORTED THAT A MI TRIAL FEM HEAD 32 -3 WAS FOUND CRACKED. NO CASE INVOLVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11099913 ↗
• InjuryDec 28, 2020Break; Break

  IT WAS REPORTED THAT DURING SURGERY, THE MI TRIAL FEMORAL HEAD 32 -3 BROKE INSIDE THE PATIENT. PROCEDURE CONTINUED WITH A BACKUP DEVICE FROM SMITH AND NEPHEW AND WITHOUT A DELAY. FURTHER DETAILS ARE UNKNOWN. 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 11083732 ↗
• MalfunctionDec 24, 2020Break; Break

  IT WAS REPORTED THAT, THE INNER FLANGE OF THE MI TRIAL FEM HEAD 32 -3 THAT ENGAGED WITH FEMORAL STEM BROKE AWAY. NO CASE REPORTED; THEREFORE, THERE WAS NO PATIENT INVOLVEMENT. 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 11072335 ↗
• MalfunctionSep 29, 2020Break; Break

  IT WAS REPORTED THAT ONE OF LOCKING TAPER TABS OF THE MI TRIAL FEM HEAD 32 -3 BROKE DURING USE. NO DELAY. PROCEDURE CONCLUDED WITH THE SAME DEVICE. NO INJURIES REPORTED AT THIS TIME. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED. IF ADDITIONAL INFORMATION SHOULD BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED ACCORDINGLY.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 10604126 ↗
• MalfunctionSep 24, 2020Naturally Worn; Naturally Worn

  IT WAS REPORTED THAT UPON INSPECTION THE PLASTIC RING INSIDE THE TRIAL WAS TORN, THE OUTSIDE WAS EXTREMELY SCRATCHED UP AND WORN OUT. NO CASE INVOLVED.

  Patient problems: No Patient Involvement

  MAUDE report 10583588 ↗
• MalfunctionSep 24, 2019Break; Break

  IT WAS REPORTED THAT DURING SURGERY THE TAB BROKE OFF THE INNER PORTION OF THE HEAD TRIAL. NO DELAY WAS REPORTED AND A BACKUP DEVICE WAS AVAILABLE. THE DEVICE BROKE INSIDE THE PATIENT BUT ALL THE PIECES WERE RECOVERED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9112467 ↗

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