NA 71369722Recalls & reported problems

Summary

The FDA's MAUDE database contains 17 adverse event reports that list this exact device (DI 03596010559937), received between May 28, 2020 and Apr 12, 2024 — classified as 3 injuries, 14 malfunctions.

The most frequently reported specific device problem is “Fracture” (7 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 17 most recent of 17 reports, in the reporter's own words as published by the FDA.

• MalfunctionApr 12, 2024Fracture; Fracture

  IT WAS REPORTED THAT, DURING A THR SURGERY, TWO TABS ON THE INSIDE OF ONE (1) MI TRIAL FEM HEAD 36 +4 WERE BROKEN. IT IS UNKNOWN IF PIECES FELL INTO 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 19097336 ↗
• MalfunctionJun 7, 2023Fracture; Fracture

  IT WAS REPORTED THAT DURING A THR, ONE OF THE INNER RETAINING TABS ON TRIAL FEMORAL HEAD 36 M/+4 BROKE OFF. BROKEN PIECES DID NOT FALL IN THE WOUND. NO RETRIEVAL NECESSARY. NO PATIENT AFFECTATION AND ALL PARTS WERE RECOVERED. THE PROCEDURE WAS RESUMED, WITHOUT ANY DELAY, USING A S+N BACK UP TRAIL. PATIENT WAS NOT HARMED AS CONSEQUENCE OF THIS PROBLEM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17084169 ↗
• MalfunctionApr 25, 2023Fracture; Fracture

  IT WAS REPORTED THAT, DURING TOTAL HIP REPLACEMENT, ONE (1) MI TRIAL FEM HEAD 36 +4 BROKE. IT IS UNKNOWN IF PIECES FELL INTO THE PATIENT. THE PROCEDURE WAS RESUMED, WITHOUT ANY DELAY, USING THE SAME DEVICE. PATIENT WAS NOT HARMED AS CONSEQUENCE OF THIS PROBLEM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16806909 ↗
• MalfunctionMar 23, 2023Fracture; Fracture

  IT WAS REPORTED THAT, DURING A THR SURGERY IT WAS NOTICED THAT, ONE (1) OF THE TABS INSIDE THE HEAD OF THE MI TRIAL FEM HEAD 36 +4 BROKE OFF. THE PIECE WAS RETRIEVED AND ALL THE PIECES ACCOUNTED FOR. THE PROCEDURE WAS RESUMED, WITHOUT ANY DELAY, USING THE SAME DEVICE. PATIENT WAS NOT HARMED AS CONSEQUENCE OF THIS PROBLEM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16607580 ↗
• MalfunctionSep 30, 2022Fracture; Fracture

  IT WAS REPORTED THAT, DURING A THR SURGERY, A MI TRIAL FEM HEAD 36 +4 WAS CRACKED. ALL PIECES WERE RETRIEVED. IT IS UNKNOWN IF PIECES FELL INTO THE PATIENT. SURGERY WAS FINISHED WITHOUT ANY DELAY WITH THE SAME DEVICE. NO HARM TO THE PATIENT OR FURTHER COMPLICATIONS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15519144 ↗
• MalfunctionSep 13, 2022Fracture; Break; Fracture

  IT WAS REPORTED THAT AFTER SURGERY, ONE OF THE TABS OF THE MI TRIAL FEM HEAD 36 +4 BROKE OFF. NO CASE INVOLVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15415257 ↗
• MalfunctionJul 20, 2022Fracture; Fracture

  IT WAS REPORTED THAT ONE (1) TRIAL FEMORAL HEAD 36 M/+4 BROKE OFF AND IT WAS 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 15066957 ↗
• MalfunctionSep 29, 2021Crack; Naturally Worn; Crack; Naturally Worn

  IT WAS REPORTED THAT A FEMORAL HEAD IMPACTOR TIP IS BROKEN AND MISSING, FIVE (5) MI TRIAL FEM HEAD TRIALS ARE CRACKED AND WORN, AND AN ANTHOLOGY STD BROACH IS DULL AND WORN. AS THIS WAS NOTICED UPON FIELD INSPECTION, THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12546009 ↗
• MalfunctionJul 14, 2021Break; Break

  IT WAS REPORTED THAT A MI TRIAL FEM HEAD 36 +4 IS BROKEN. AS THIS WAS NOTICED IN A NON-SURGICAL ENVIRONMENT, THERE WAS NO PATIENT INVOLVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12165951 ↗
• InjuryMay 27, 2021Break; Break

  IT WAS REPORTED THAT, DURING SURGERY, THE INNER TABS OF 3 MI TRIAL FEM HEAD 36 +4 BROKE OFF. DEVICE INSIDE THE PATIENT. 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 11894046 ↗
• InjuryMay 27, 2021Break; Break

  IT WAS REPORTED THAT, DURING SURGERY, THE INNER TABS OF THREE (3) MI TRIAL FEM HEAD 36 +4 BROKE OFF. DEVICE INSIDE THE PATIENT. 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 11894022 ↗
• InjuryMay 27, 2021Break; Break

  IT WAS REPORTED THAT, DURING SURGERY, THE INNER TABS OF THREE (3) MI TRIAL FEM HEAD 36 +4 BROKE OFF. DEVICE INSIDE THE PATIENT. 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 11893998 ↗
• MalfunctionMay 13, 2021Break; Break

  IT WAS REPORTED THAT, DURING A THR, A MI TRIAL FEM HEAD 36 +4 WAS OBSERVED TO HAVE ONE OF THE FOUR LOCKING TABS BROKEN. TABS ARE USED TO SECURE THE TRIAL HEAD TO THE REUNION OF THE STEM OR THE TRIAL NECK. INSTRUMENT OUTSIDE THE PATIENT. 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 11817248 ↗
• MalfunctionApr 19, 2021Connection Problem; Material Deformation; Connection Problem; Material Deformation

  IT WAS REPORTED THAT SURGICAL REPROCESSING TEAM NOTICED THAT 3 OF THE MI TRIAL FEM HEAD 36 +4 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 11683741 ↗
• MalfunctionApr 19, 2021Connection Problem; Material Deformation; Connection Problem; Material Deformation

  IT WAS REPORTED THAT SURGICAL REPROCESSING TEAM NOTICED THAT 3 OF THE MI TRIAL FEM HEAD 36 +4 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 11683738 ↗
• MalfunctionApr 19, 2021Connection Problem; Material Deformation; Connection Problem; Material Deformation

  IT WAS REPORTED THAT SURGICAL REPROCESSING TEAM NOTICED THAT 3 OF THE MI TRIAL FEM HEAD 36 +4 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 11683736 ↗
• MalfunctionMay 28, 2020Device Damaged Prior to Use; Device Damaged Prior to Use

  IT WAS REPORTED THAT DURING INSPECTION IT WAS NOTICED THAT THE INTERNAL PLASTIC CONNECTING PARTS ARE CHIPPED AND MISSHAPEN DUE TO NORMAL USE. NO CASE INVOLVED. NO PATIENT INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10097757 ↗

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