NA 71366517Recalls & reported problems

Summary

The FDA's MAUDE database contains 35 adverse event reports that list this exact device (DI 00885556110119), received between Feb 17, 2019 and Feb 3, 2026 — classified as 4 injuries, 31 malfunctions.

The most frequently reported specific device problem is “Break” (24 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. What reports can and can't tell you · How this data works · Data updated Oct 16, 2026.

Most reported problems

Recent adverse event reports

The 25 most recent of 35 reports, in the reporter's own words as published by the FDA.

• MalfunctionFeb 3, 2026Fracture

  IT WAS REPORTED THAT, DURING A THA SURGERY, A TINE ON THE INSIDE OF ONE (1) FEMORAL HEAD TRIAL 12/14 40 +0 BROKE OFF. IT IS UNKNOWN IF ANY PIECE FELL INSIDE THE PATIENT. THE PROCEDURE WAS RESUMED, WITHOUT ANY DELAY, USING THE SAME DEVICE. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24246704 ↗
• MalfunctionDec 5, 2024Break; Break

  IT WAS REPORTED THAT, DURING THR SURGERY, THE ENGAGEMENT AREA WERE THE HEAD SEATS IN ONE (1) FEMORAL HEAD TRIAL 12/14 40 +0 BROKE. NO PIECES WERE LEFT IN THE PATIENT, THE BROKEN PLASTIC FROM THE HEAD WAS IDENTIFIED, REMOVED WITH A PICK UP AND ACCOUNTED FOR. 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 20854250 ↗
• MalfunctionDec 5, 2024Break; Break

  IT WAS REPORTED THAT DURING A TKA SURGERY, THE FEMORAL HEAD TRIAL 12/14 40 +0 BROKE DURING THE RELOCATION OF THE HIP. THE PROCEDURE WAS PERFORMED, AFTER NO DELAY, USING A S+N BACK-UP DEVICE. PATIENT WAS NOT HARMED AS CONSEQUENCE OF THIS PROBLEM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20854190 ↗
• MalfunctionJan 20, 2024Fracture; Fracture

  IT WAS REPORTED THAT, DURING A THR, THE TABS ON THE INSIDE OF ONE (1) FEMORAL HEAD TRIAL 12/14 40 +0 BROKE. 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 18548859 ↗
• MalfunctionDec 18, 2023Fracture; Fracture

  IT WAS REPORTED THAT, DURING THR SURGERY, IT WAS NOTICED THAT ONE (1) FEMORAL HEAD TRIAL 12/14 40 +0 HAD THE PLASTIC CHIPPED. THE PROCEDURE HAD BEEN COMPLETED, WITHOUT ANY DELAY, WITH A S+N BACK-UP DEVICE. PATIENT WAS NOT HARMED AS CONSEQUENCE OF THIS PROBLEM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18352289 ↗
• MalfunctionOct 30, 2023Fracture; Fracture

  IT WAS REPORTED THAT DURING A THR SURGERY, THE INSIDE PART OF THE FEMORAL HEAD TRIAL 12/14 40 +0 CHIPPED SO IT DOES NOT SIT PROPERLY ON THE NECK OF THE TRIAL/STEM. NOTHING WAS FOUND INSIDE 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 18034759 ↗
• MalfunctionJul 11, 2023Break; Break

  IT WAS REPORTED THAT DURING A THR SURGERY, ONE OF THE 4 INNER LOCKING SIDES OF A FEMORAL HEAD TRIAL 12/14 TAPER40 +0 WAS BROKEN OFF. THERE WAS A NON-SIGNIFICANT 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 17302855 ↗
• MalfunctionJun 20, 2023Fracture; Fracture

  IT WAS REPORTED, THAT DURING A THR SURGERY. THE TAB BROKE OFF INSIDE THE FEMORAL HEAD TRIAL 12/14 40 +0. ALL PIECES WERE RETRIEVED. THE PROCEDURE WAS AFTER A NON-SIGNIFICANT 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 17162221 ↗
• MalfunctionJun 10, 2023Fracture; Fracture

  IT WAS REPORTED THAT, DURING A THR, THE INNER TAB OF ONE (1) FEMORAL HEAD TRIAL 12/14 40 +0 BROKE DURING TRAILING. THE PROCEDURE WAS PERFORMED, 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 17102155 ↗
• MalfunctionMar 3, 2023Fracture; Fracture

  IT WAS REPORTED THAT, DURING A THR SURGERY, IT WAS NOTICED THAT ONE OF THE TABS ON THE INSIDE OF ONE (1) FEMORAL HEAD TRIAL 12/14 40 +0 BROKE DURING REDUCTION, THE BROKEN PIECE WAS RETRIEVED. 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 16482286 ↗
• MalfunctionDec 6, 2022Fracture; Fracture

  IT WAS REPORTED THAT, DURING A THR SURGERY, A FEMORAL HEAD TRIAL 12/14 40 +0 IS CHIPPED ON INSIDE. A PICTURE OF THE REPORTED DEVICE SHOWS ONE OF THE FOUR PIECES OF THE LOCKING MECHANISM HAS FRACTURED OFF. 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 15926028 ↗
• MalfunctionOct 4, 2022Fracture; Fracture

  IT WAS REPORTED THAT, THE INNER LIPS OF A FEMORAL HEAD TRIAL 12/14 40 +0 WERE BROKEN. AS THIS WAS NOTICED UPON FIELD INSPECTION, NO PATIENT WAS INVOLVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15535480 ↗
• MalfunctionSep 15, 2022Fracture; Fracture

  IT WAS REPORTED THAT ONE (1) FEMORAL HEAD TRIAL 12/14 40 +0 WAS BROKEN. AS THIS WAS NOTICED IN A NON-SURGICAL ENVIRONMENT, THERE WAS NOT PATIENT INVOLVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15434658 ↗
• InjuryJul 21, 2022Break; Break

  IT WAS REPORTED THAT, DURING A THR SURGERY THE FEMORAL HEAD TRIAL 12/14 40 +0 INNER TAB BROKE DURING TRIAL REDUCTION. ALL PIECES RECOVERED, NO PATIENT AFFECTATION. THE PROCEDURE WAS COMPLETED, WITHOUT DELAY. NO FURTHER COMPLICATION WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15076050 ↗
• MalfunctionJun 9, 2022Break; Break

  IT WAS REPORTED THAT THE FEMORAL HEAD TRIAL 12/14 40 +0 BROKE. AS THIS WAS FOUND OUT DURING FACILITY INSPECTION, NO PATIENT WAS INVOLVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14644930 ↗
• MalfunctionApr 6, 2022Break; Break

  IT WAS REPORTED THAT A FEMORAL HEAD TRIAL 12/14 40 +0 WAS FOUND BROKEN. AS THIS WAS NOTICED IN A FIELD INSPECTION, NO PATIENT WAS INVOLVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14022085 ↗
• MalfunctionMar 1, 2022Break; Break

  IT WAS REPORTED THAT THE INSIDE OF A FEMORAL HEAD TRIAL 12/14 TAPER40 +0 BROKE. AS THIS WAS NOTICED UPON INSPECTION, THERE WAS NOT PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13636253 ↗
• MalfunctionFeb 9, 2022Break; Break

  IT WAS REPORTED THAT THE FEMORAL HEAD TRIAL 12/14 40 +0 BROKE ON THE INSIDE. AS THIS WAS NOTICED UPON FIELD INSPECTION, NO PATIENT WAS INVOLVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13502764 ↗
• InjuryDec 8, 2021Break; Break

  IT WAS REPORTED THAT, DURING THR SURGERY, THE INNER TABS OF FEMORAL HEAD TRIAL 12/14 40 +0 BROKE OFF INSIDE THE PATIENT. ALL PARTS ACCOUNTED FOR. 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 12964935 ↗
• MalfunctionNov 15, 2021Break; Break

  IT WAS REPORTED THAT THE INTERNAL NECK OF A TRIAL FEMORAL HEAD 40 S/+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 12814196 ↗
• MalfunctionJun 9, 2021Break; Break

  IT WAS REPORTED THAT THE FEMORAL HEAD TRIAL 12/14 40 +0 BROKE. AS THIS WAS NOTICED UPON FIELD INSPECTION, NO PATIENT WAS INVOLVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11968571 ↗
• MalfunctionMay 31, 2021Break; Break

  IT WAS REPORTED THAT A FEMORAL HEAD TRIAL 12/14 40 +0 WAS BROKEN. SINCE IT WAS NOTICED DURING A FIELD INSPECTION, NO PATIENT WAS INVOLVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11909322 ↗
• InjuryApr 25, 2021Break; Break

  IT WAS REPORTED THAT, DURING THR SURGERY, THE PLASTIC INSIDE THE 40MM FEMORAL HEAD TRIAL +0 BROKE OFF WHILE BEING USED INSIDE THE PATIENT. THE PROCEDURE FINISHED WITH THE SAME DEVICE AND IT WAS DELAYED LESS THAN OR EQUAL TO 30MIN.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11722119 ↗
• MalfunctionApr 19, 2021Break; Break

  IT WAS REPORTED THAT DURING INSPECTION THE INTERNAL CAPTURE PIECE OF THE FEMORAL HEAD TRIAL 12/14 40 +0 SNAPPED OFF. NO CASE INVOLVED THEREFORE NO PATIENT IMPACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11683761 ↗
• MalfunctionMar 8, 2021Material Integrity Problem; Material Integrity Problem

  IT WAS REPORTED THAT, THE FEMORAL HEAD TRIAL 12/14 40 +0 CAME BACK IN OFFICE SET WITH LARGE GASH TAKEN OUT OF IT. NO CASE REPORTED; THEREFORE, THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11431676 ↗

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