NA 71360484Recalls & reported problems

Summary

The FDA's MAUDE database contains 48 adverse event reports that list this exact device (DI 00885556024362), received between Jul 30, 2019 and Jan 19, 2026 — classified as 17 injuries, 31 malfunctions.

The most frequently reported specific device problem is “Break” (28 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 18, 2026.

Most reported problems

Recent adverse event reports

The 25 most recent of 48 reports, in the reporter's own words as published by the FDA.

• MalfunctionJan 19, 2026Break

  IT WAS REPORTED THAT, DURING A THA SURGERY, WHEN THE SURGEON WAS IMPACTING THE FEMORAL HEAD ONTO THE STEM AND THE TIP OF THE IMPACTOR BROKE. THE PROCEDURE WAS RESUMED, 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 24111910 ↗
• MalfunctionJul 2, 2025Fracture; Fracture

  IT WAS REPORTED THAT DURING A THR, THE FEM HD/NECK IMPCTR RPMT TIP BROKE, WHEN IMPACTING. IT IS UNKNOWN HOW PROCEDURE WAS FINISHED AND IF THERE WAS ANY DELAY. NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22391784 ↗
• MalfunctionMay 27, 2025Fracture; Fracture

  IT WAS REPORTED THAT, DURING A THR SURGERY, THE EDGE OF A FEM HD/NECK IMPCTR RPMT TIP BROKE OFF. 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 22089085 ↗
• MalfunctionApr 17, 2025Fracture; Fracture

  IT WAS REPORTED THAT, DURING A THR SURGERY, ONE (1) FEM HD/NECK IMPCTR RPMT TIP BROKE IN HALF WHILE IMPACTING THE HEAD. ALL PIECES WERE FOUND, NOTHING FELL IN THE WOUND, THE DEVICE WAS THROWN ON THE GROUND ONCE IT BROKE. 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 21862186 ↗
• MalfunctionMar 31, 2025Fracture; Fracture

  IT WAS REPORTED THAT DURING A THR, ONE (1) FEM HD/NECK IMPCTR RPMT TIP BROKE AFTER BEING STUCK WITH MALLET. THE PROCEDURE WAS COMPLETED WITHOUT DELAY USING A S+N BACK-UP DEVICE. ALL PIECES RETRIEVED, NOTHING FELL INTO PATIENT. NO INJURY WAS REPORTED AS A CONSEQUENCE OF THIS ISSUE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21731005 ↗
• MalfunctionMar 6, 2025Fracture; Fracture

  IT WAS REPORTED THAT DURING SURGERY, A PIECE OF ONE (1) FEM HD/NECK IMPCTR RPMT TIP BROKE OFF AFTER BEING STRUCK WITH MALLET. THE PROCEDURE WAS COMPLETED WITHOUT DELAY USING A S+N BACK-UP DEVICE. NO INJURY WAS REPORTED AS A CONSEQUENCE OF THIS ISSUE ANA ALL PIECES WERE RETRIEVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21543067 ↗
• MalfunctionSep 2, 2024Fracture; Fracture

  IT WAS REPORTED THAT, DURING THR SURGERY, FOLLOWING IMPACTION OF THE FEMORAL HEAD, ONE (1) FEM HD/NECK IMPCTR RPMT TIP FRACTURED AND FELL ON THE FLOOR. THE PROCEDURE WAS RESUMED, AFTER A NON-SIGNIFICANT DELAY, WITH A COMPETITOR DEVICE. NO INJURY WAS REPORTED AS A CONSEQUENCE OF THIS ISSUE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20118242 ↗
• InjuryMay 22, 2024Fracture; Fracture

  IT WAS REPORTED THAT, AFTER A THR SURGERY PERFORMED ON (B)(6) 2024 A PIECE OF THE PLASTIC TIP OF ONE (1) FEM HD/NECK IMPCTR RPMT TIP WAS FOUND IN THE CONSTRAINED LINER. THESE PIECES WERE DISCOVERED AS THE IMPLANT KEPT DISLOCATING. A REVISION SURGERY WAS PERFORMED ON (B)(6) 2024 TO SOLVE THE ISSUE. DURING THIS PROCEDURE ALL THE BROKEN PIECES WERE REMOVED AND ACCOUNTED FROM INSIDE THE IMPLANT. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: Foreign Body In Patient; Joint Dislocation

  MAUDE report 19372714 ↗
• MalfunctionMay 31, 2023Fracture; Fracture

  IT WAS REPORTED THAT, DURING A THR, THE FEM HD/NECK IMPCTR RPMT TIP BROKE UPON IMPACTION. HOWEVER, ALL PIECES WERE RECOVERED. SURGERY WAS RESUMED, WITHOUT ANY DELAY, WITH A SMITH AND NEPHEW BACK-UP DEVICE. PATIENT WAS NOT HARMED AS CONSEQUENCE OF THIS PROBLEM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17035122 ↗
• MalfunctionNov 12, 2022Fracture; Fracture

  IT WAS REPORTED THAT, DURING A THR SURGERY, THE FEMORAL HEAD/NECK IMPACTOR REPLACEMENT TIP BROKE. SURGERY WAS RESUMED, WITHOUT ANY DELAY, WITH THE SAME DEVICE. PATIENT WAS NOT HARMED AS CONSEQUENCE OF THIS PROBLEM. AFTER VISUAL INSPECTION OF THE RETURNED DEVICE DID NOT CONFIRM THE STATED FAILURE. THERE IS NOTHING BROKE OFF OR NO THE DEVICE. THE DEVICE IS INTACT. THE DEVICE SHOWS NO SIGNS OF WEAR OR USE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15785909 ↗
• MalfunctionOct 22, 2022Fracture; Fracture

  IT WAS REPORTED THAT, DURING SURGERY, THE HEAD OF THE FEM HD/NECK IMPCTR RPMT TIP SHEARED OFF IN HALF, THEREFORE IS UNUSABLE. DEVICE 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 15656089 ↗
• MalfunctionOct 5, 2022Fracture; Fracture

  IT WAS REPORTED THAT, DURING A ROUTINE INSPECTION, A FEM HD/NECK IMPCTR RPMT TIP BROKE. AS THIS WAS NOTICED IN A NON-SURGICAL ENVIRONMENT, NO PATIENT WAS INVOLVED. NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15544692 ↗
• MalfunctionJul 26, 2022Fracture; Fracture

  IT WAS REPORTED THAT, DURING A THR SURGERY, THE FEM HD/NECK IMPCTR RPMT TIP CRACKED. SURGERY WAS FINISHED WITHOUT ANY DELAY, WITH THE SAME DEVICE. NO HARM TO THE PATIENT OR FURTHER COMPLICATIONS REPORTED. ON PRELIMINARY INVESTIGATION, DURING VISUAL INSPECTION IT WAS FOUND THAT DEVICE IS FRACTURE, WHICH MAKES IT A REPORTABLE EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15108589 ↗
• MalfunctionJul 23, 2022Fracture; Fracture

  IT WAS REPORTED THAT, THE FEM HD/NECK IMPCTR RPMT TIP WAS BROKEN. IT IS UNKNOWN WHETHER THIS PROBLEM WAS NOTICED IN A SURGICAL ENVIRONMENT OR NOT; THEREFORE, PATIENT INVOLVEMENT HAS NOT BEEN CONFIRMED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15090394 ↗
• InjuryJun 10, 2022Break; Break

  IT WAS REPORTED THAT, DURING A THR SURGERY, TWO (2) FEM HD/NECK IMPCTR RPMT TIP BROKE. ALL PIECES RETRIEVED BY HAND. THE PROCEDURE WAS COMPLETED, WITHOUT DELAY, USING A S+N BACK UP DEVICE. PATIENT WAS NOT HARMED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14655189 ↗
• MalfunctionApr 4, 2022Break; Break

  IT WAS REPORTED THAT, A FEM HD/NECK IMPCTR RPMT TIP WAS BROKEN. AS THIS WAS NOTICE IN A FIELD INSPECTION, NOT PATIENT WAS INVOLVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13996209 ↗
• MalfunctionJan 18, 2022Break; Naturally Worn; Material Split, Cut or Torn; Break; Naturally Worn; Material Split, Cut or Torn

  IT WAS REPORTED THAT A FEMORAL HEAD/NECK IMPACTOR REPLACEMENT TIP IS DAMAGED DUE TO WEAR AND TEAR. AS THIS WAS NOTICED UPON FIELD INSPECTION, THERE WAS NO PATIENT INVOLVEMENT. MOREOVER, DURING INVESTIGATION IT WAS FOUND THAT THE DEVICE IS CHIPPED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13282336 ↗
• MalfunctionJan 5, 2022Break; Break

  IT WAS REPORTED THAT, DURING A THR SURGERY, A FEM HD/NECK IMPCTR RPMT TIP BROKE INSIDE HANDLE. SURGERY WAS COMPLETED, WITHOUT ANY DELAY, USING A SN BACK-UP DEVICE. NO HARM TO THE PATIENT OR FURTHER COMPLICATIONS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13170957 ↗
• MalfunctionDec 28, 2021Break; Break

  IT WAS REPORTED THAT, AFTER TOTAL HIP REPLACEMENT, A FEMORAL HEAD/NECK IMPACTOR REPLACEMENT TIP WAS OBSERVED TO BE CRACKED IN PIECES. AS THIS HAPPENED AFTER SURGERY WAS CONCLUDED, THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13094307 ↗
• InjuryNov 9, 2021Break; Break

  IT WAS REPORTED THAT, DURING A THR SURGERY, A FEMORAL HEAD/NECK IMPACTOR REPLACEMENT TIP WAS BROKEN, NO PIECES FELL INSIDE THE PATIENT. SURGERY WAS RESUMED, WITHOUT ANY DELAY, WITH A BACK-UP DEVICE. PATIENT WAS NOT INJURED AS CONSEQUENCE OF THIS PROBLEM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12780045 ↗
• MalfunctionOct 5, 2021Break; Break

  IT WAS REPORTED THAT THE FEMORAL HEAD/NECK IMPACTOR REPLACEMENT TIP 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 12577515 ↗
• MalfunctionAug 17, 2021Break; Break

  IT WAS REPORTED THAT A FEM HD/NECK IMPCTR RPMT TIP BROKE. IT IS UNKNOWN WHEN THIS HAPPENED, THEREFORE PATIENT INVOLVEMENT IS NOT CONFIRMED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12332305 ↗
• MalfunctionJul 13, 2021Break; Break

  IT WAS REPORTED THAT, DURING A FIELD INSPECTION, A FEM HD/NECK IMPCTR RPMT TIP WAS FOUND 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 12159076 ↗
• MalfunctionJul 7, 2021Break; Break

  IT WAS REPORTED THAT WHILE INSPECTING INSTRUMENTS, A FEM HD/NECK IMPCTR RPMT TIP WAS CRACKED AND BROKEN. NO PATIENT INVOLVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12131877 ↗
• InjuryJul 5, 2021Break; Break

  IT WAS REPORTED THAT, DURING A THA, THE HEAD IMPACTOR OF THE FEM HD/NECK IMPCTR RPMT TIP BROKE. THE DEVICE EXPLODED UPON FINAL HEAD IMPACT. PLASTIC PIECES HAD TO BE PICKED OUT OF THE WOUND AND PIECED BACK TOGETHER TO MAKE SURE NO RESIDUAL PARTS WERE LEFT BEHIND. IT IS UNKNOWN HOW THE PROCEDURE WAS FINISHED AND IF IT WAS DELAYED. PATIENT OUTCOME IS ALSO UNKNOWN.

  Patient problems: Insufficient Information; No Clinical Signs, Symptoms or Conditions

  MAUDE report 12116473 ↗

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