NA 71364009Recalls & reported problems

Summary

The FDA's MAUDE database contains 174 adverse event reports that list this exact device (DI 03596010199256), received between Jan 25, 2019 and May 3, 2026 — classified as 13 injuries, 161 malfunctions.

The most frequently reported specific device problem is “Break” (133 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 25 most recent of 174 reports, in the reporter's own words as published by the FDA.

• MalfunctionMay 3, 2026Break

  IT WAS REPORTED THAT, DURING A THA SURGERY, THE TIP OF THE FEMORAL HEAD IMPACTOR BROKE. THE PROCEDURE WAS PERFORMED, 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 25063017 ↗
• MalfunctionApr 18, 2026Fracture

  IT WAS REPORTED THAT, DURING A THA SURGERY, UPON FINAL IMPACTION OF FEMORAL HEAD, THE BLACK PLASTIC OF THE TIP OF A FEMORAL HEAD IMPACTOR BROKE INTO THREE PIECES. 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 24919502 ↗
• MalfunctionMar 20, 2026Fracture

  IT WAS REPORTED THAT, DURING A THR SURGERY, THE PLASTIC HEAD OF ONE (1) FEMORAL HEAD IMPACTOR CRACKED AND BROKE OFF IN 3 PIECES DURING HEAD IMPACTION. ONE PIECE FELL OUT OF THE PATIENT AND THE OTHER 2 PIECES WERE RETRIEVED WITH A PICK UP THE PROCEDURE WAS RESUMED, AFTER A NON-SIGNIFICANT DELAY, USING A COMPETITOR DEVICE (HOSPITAL FEMORAL HEAD IMPACTOR). NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24649405 ↗
• MalfunctionMar 5, 2026Fracture

  IT WAS REPORTED THAT, DURING A REVISION HIP SURGERY, A FEMORAL HEAD IMPACTOR BROKE. THE PLASTIC SCREW IN THE IMPACTOR BROKE IN HALF DURING IMPACT. 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 24520062 ↗
• MalfunctionFeb 27, 2026Insufficient Device Problem Information

  IT WAS REPORTED THAT, DURING A THR REVISION SURGERY, THE FEMORAL HEAD IMPACTOR HAD A PRESENTED AN UNSPECIFIC FAILURE. SURGERY WAS PERFORMED, WITHOUT ANY DELAY, WITH AN EQUIVALENT S+N BACK-UP. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24473387 ↗
• MalfunctionJan 25, 2026Break

  IT WAS REPORTED THAT, DURING A THA SURGERY, THE TIP OF ONE (1) FEMORAL HEAD IMPACTOR BROKE WHILE IMPACTING THE HEAD ONTO THE STEM. 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 24175720 ↗
• MalfunctionNov 15, 2025Break; Break

  IT WAS REPORTED THAT, DURING A THR SURGERY, THE TIPS OF TWO (2) FEMORAL HEAD IMPACTOR WERE BROKEN. 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 23564234 ↗
• MalfunctionOct 22, 2025Fracture; Fracture

  IT WAS REPORTED THAT DURING A THR, THE FEMORAL HEAD IMPACTOR BROKE WHILE IMPACTING A FEMORAL IMPLANT. IT IS UNKNOWN IF ANY PIECE FELL INSIDE PATIENT'S ANATOMY. THERE WAS NO HARM TO PATIENT. IT IS UNKNOWN HOW THE PROCEDURE WAS PERFORMED AND IF THERE WAS ANY DELAY. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23364025 ↗
• MalfunctionJul 10, 2025Break; Break

  IT WAS REPORTED THAT DURING A THR SURGERY, ONE (1) FEMORAL HEAD IMPACTOR BROKE ON IMPACTION. ALL THE PIECES WERE REMOVED FROM THE PATIENT. 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 22469004 ↗
• MalfunctionSep 8, 2024Fracture; Fracture

  IT WAS REPORTED THAT, DURING A THR, THE PLASTIC TIP OF ONE (1) FEMORAL HEAD IMPACTOR BROKE. THE PROCEDURE WAS RESUMED, WITHOUT ANY DELAY, USING THE SAME DEVICE. PATIENT WAS NOT HARMED AS A CONSEQUENCE OF THIS PROBLEM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20165926 ↗
• MalfunctionJun 23, 2024Fracture; Fracture

  IT WAS REPORTED THAT, DURING A THR SURGERY, THE TIP OF A FEMORAL HEAD IMPACTOR BROKE. IT IS UNKNOWN HOW PROCEDURE WAS COMPLETED, NO DELAY OCCURRED DUE TO THIS EVENT. NO OTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19591827 ↗
• MalfunctionApr 11, 2024Break; Break

  IT WAS REPORTED THAT DURING A THR SURGERY, THE PLASTIC HEAD OF THE FEMORAL HEAD/NECK IMPACTOR BROKE DURING USE, EXTERNAL TO 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 19088610 ↗
• MalfunctionApr 5, 2024Break; Break

  IT WAS REPORTED THAT, DURING A THR SURGERY, THE SURGEON TRIED TO USE A FEMORAL HEAD IMPACTOR TO KNOCK OFF A FEMORAL HEAD OF A STEM, AND THE PLASTIC BROKE. 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 19051692 ↗
• MalfunctionFeb 2, 2024Break; Fracture; Break; Fracture

  IT WAS REPORTED THAT DURING A THR SURGERY, THE FEMORAL HEAD IMPACTOR BROKE WHILE IMPACTING IMPLANT. INSTRUMENT BROKE WHILE BEING USED ON PATIENT OUTSIDE BODY SO NO PIECES WENT MISSING OR INTO 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 18630441 ↗
• MalfunctionJan 8, 2024Fracture; Fracture

  IT WAS REPORTED THAT, DURING THR SURGERY, WHILE UTILIZING ONE (1) FEMORAL HEAD IMPACTOR, IT BROKE WHILE IMPACTING THE HEAD. ALL PARTS THAT FRACTURED WERE RECOVERED BY HAND. NO PARTS LEFT IN 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 18466806 ↗
• MalfunctionNov 20, 2023Crack; Crack

  IT WAS REPORTED THAT, DURING A THR SURGERY, THE PLASTIC TIP OF A FEMORAL HEAD IMPACTOR CRACKED DURING IMPACTION. IT IS UNKNOWN HOW THE PROCEDURE WAS FINISHED. NO INJURY OR DELAY WERE REPORTED AS A CONSEQUENCE OF THIS ISSUE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18171183 ↗
• MalfunctionJul 20, 2023Fracture; Fracture

  IT WAS REPORTED THAT DURING A THR SURGERY, THE PLASTIC TIP OF THE FEMORAL HEAD IMPACTOR DEVICE FRACTURED WHEN IMPACTING. THE PIECE WAS RECOVERED. 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 17358384 ↗
• MalfunctionJun 10, 2023Fracture; Fracture

  IT WAS REPORTED THAT, DURING A TKA, A FEMORAL HEAD IMPACTOR BROKE WHEN IMPACTING THE FEMORAL HEAD IMPLANT. ALL OF THE PIECES THAT FELL INTO THE PATIENT WERE RETRIEVED VIA SUCTION, HOWEVER NO X-RAY IS AVAILABLE. SURGERY WAS RESUMED, WITHOUT ANY DELAY, WITH THE SAME DEVICE. NO PATIENT HARM WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17102150 ↗
• MalfunctionMay 25, 2023Fracture; Fracture

  IT WAS REPORTED THAT, DURING A THR SURGERY, THE TIP OF A FEMORAL HEAD IMPACTOR BROKE OFF WHILE REDUCING THE HIP AT THE END OF THE PROCEDURE. ALL THE PIECES WERE ACCOUNTED FOR. THE PROCEDURE WAS FINISHED, WITHOUT ANY DELAY, USING THE SAME DEVICE. NO INJURY WAS REPORTED DUE TO THIS ISSUE. 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 17007754 ↗
• MalfunctionMay 20, 2023Fracture; Fracture

  IT WAS REPORTED THAT DURING A THR, THE PLASTIC HEAD PIECE OF ONE (1) FEMORAL HEAD IMPACTOR CHIPPED WHILE IMPACTING THE FEMORAL HEAD. NOTHING FELL INTO 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 16970547 ↗
• MalfunctionApr 21, 2023Break; Detachment of Device or Device Component; Break; Detachment of Device or Device Component

  IT WAS REPORTED THAT THE BLACK PLASTIC TIP OF A FEMORAL HEAD IMPACTOR FRACTURED. BLACK IMPACTOR TIP BROKE WHILE REDUCING THE HIP. THE PIECE THAT BROKE WAS RECOVERED FROM PATIENT. PATIENT IMPACT IS YET TO BE DETERMINED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16792468 ↗
• MalfunctionApr 20, 2023Fracture; Fracture

  IT WAS REPORTED THAT, DURING A THR SURGERY, THE PLASTIC HEAD OF ONE (1) FEMORAL HEAD IMPACTOR BROKE AFTER IMPACTING FEMORAL HEAD. NO PIECES FELL INTO 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 16781990 ↗
• MalfunctionApr 18, 2023Material Fragmentation; Material Fragmentation

  IT WAS REPORTED, THAT DURING THR SURGERY, THE PLASTIC END OF A FEMORAL HEAD IMPACTOR SHATTERED DURING USE. ALL PIECES WERE RECOVERED. SURGERY WAS RESUMED, 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 16759066 ↗
• MalfunctionFeb 27, 2023Fracture; Fracture

  IT WAS REPORTED THAT, DURING A THR SURGERY, THE TIP OF ONE (1) FEMORAL HEAD IMPACTOR BROKE WHILE TRYING TO KNOCK THE HEAD OFF IMPACTOR. 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 16449302 ↗
• MalfunctionFeb 8, 2023Break; Break

  IT WAS REPORTED THAT, DURING THR, THE HEAD OF ONE (1) FEMORAL HEAD IMPACTOR BROKE. 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 16325453 ↗

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