NA 71360093Recalls & reported problems

Summary

The FDA's MAUDE database contains 134 adverse event reports that list this exact device (DI 03596010619310), received between Nov 1, 2018 and Mar 31, 2026 — classified as 26 injuries, 108 malfunctions.

The most frequently reported specific device problem is “Break” (83 reports).

1 other recall cover devices cleared under the same FDA submission (K113789); 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 134 reports, in the reporter's own words as published by the FDA.

• MalfunctionMar 31, 2026Break

  IT WAS REPORTED THAT DURING A THR SURGERY, THE BLACK PLASTIC TIP OF A FEMORAL HEAD/NECK IMPACTOR BROKE. THE PROCEDURE WAS RESUMED, WITHOUT ANY DELAY, USING AN EQUIVALENT S+N BACK-UP DEVICE. PATIENT WAS NOT INJURED AS CONSEQUENCE OF THIS PROBLEM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24750503 ↗
• MalfunctionDec 2, 2025Break; Fracture; Break; Fracture

  IT WAS REPORTED THAT, DURING A THR SURGERY, THE PLASTIC TIP OF THE FEMORAL HEAD/NECK 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 23700824 ↗
• MalfunctionMay 14, 2025Break; Break

  IT WAS REPORTED THAT DURING A THR SURGERY, THE PLASTIC TIP OF ONE (1) FEMORAL HEAD/NECK IMPACTOR BROKE WHILE IMPACTING A HEAD BALL. THE PROCEDURE WAS RESUMED, WITHOUT ANY SURGICAL 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 22019500 ↗
• MalfunctionFeb 4, 2025Fracture; Fracture

  IT WAS REPORTED THAT, AFTER THR SURGERY HAD BEEN PERFORMED ON AN UNKNOWN DATE WITH COMPETITOR'S PROSTHESIS, A REVISION SURGERY WAS PERFORMED ON (B)(6) 2025 DUE TO THE USEFUL LIFE OF THE PROSTHESIS, IN WHICH THE MATERIAL REMOVED WAS COMPLETELY REPLACED BY SMITH MATERIALS. AT THE MOMENT TO REMOVE THE HEAD FOLLOWING THE INSTRUCTIONS FOR USE, THE POLYETHYLENE TIP OF ONE (1) FEMORAL HEAD/NECK IMPACTOR BROKE 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 21303876 ↗
• MalfunctionDec 2, 2024Fracture; Fracture

  IT WAS REPORTED THAT, DURING THR SURGERY, WHILE INSERTING THE FEMORAL HEAD, A PIECE OF ONE (1) FEMORAL HEAD/NECK IMPACTOR SNAPPED OFF. NOTHING WAS LEFT IN THE PATIENT, AND ALL PIECES WERE RETRIEVED BY HAND WITHOUT CAUSING ANY DAMAGED TO 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 20818952 ↗
• MalfunctionSep 27, 2024Fracture; Fracture

  IT WAS REPORTED THAT DURING A TKA SURGERY, THE FEMORAL HEAD/NECK IMPACTOR BROKE WHEN IT WAS STRUCK. IT WAS OBSERVED THAT THE PIECE WAS FATIGUED AND IT WAS FRACTURED VERY EASILY. THE PROCEDURE WAS RESUMED, WITHOUT ANY DELAY, USING THE SAME DEVICE. PATIENT WAS NOT HARMED AS CONSEQUENCE OF THIS PROBLEM. THE PATIENT'S HEALTH CONDITION IS STABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20324931 ↗
• MalfunctionSep 19, 2024Fracture; Fracture

  IT WAS REPORTED THAT DURING A THR SURGERY, ON IMPACTION, THE FEMORAL HEAD/NECK IMPACTOR HEAD BROKE OFF. NOTHING FELL INTO THE PATIENT. NOTHING LEFT IN PATIENT AND ALL PIECES RETRIEVED. 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 20262989 ↗
• MalfunctionJul 22, 2024Fracture; Fracture

  IT WAS REPORTED THAT, DURING A THA SURGERY, THE TIP OF A FEMORAL HEAD/NECK IMPACTOR BROKE OFF WHILE DOCTOR WAS IMPACTING FEMORAL HEAD ON. ALL PIECES WERE RECOVERED FROM 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 19801257 ↗
• MalfunctionJul 17, 2024Fracture; Fracture

  IT WAS REPORTED THAT, DURING A THR SURGERY, THE SURGEON USED THE PUSHER AND THE TIP OF THE FEMORAL HEAD/NECK IMPACTOR CRACKED BUT WAS RETAINED INSIDE THE PUSHER. THE DEVICE WAS PROCESSED AND TIP MUST HAVE BEEN DISCARDED DURING PROCESSING. THE SURGERY WAS COMPLETED, WITHOUT ANY DELAY, WITH A S+N BACK-UP DEVICE. NO INJURIES WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19759310 ↗
• MalfunctionJul 11, 2024Fracture; Fracture

  IT WAS REPORTED THAT DURING A THR WHILE IMPACTING THE BHR FEMORAL HEAD IMPLANT ONTO THE FEMORAL HEAD THE TIP OF ONE (1) FEMORAL HEAD/NECK IMPACTOR SPLIT IN HALF RENDERING THE DEVICE USELESS. IT IS UNKNOWN HOW THE PROCEDURE WAS COMPLETED. NO PATIENT INJURIES WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19727234 ↗
• MalfunctionApr 16, 2024Fracture; Fracture

  IT WAS REPORTED THAT, DURING THR SURGERY, THE PLASTIC TIP OF ONE (1) FEMORAL HEAD/NECK IMPACTOR BROKE IN TO PIECES. IT IS UNKNOWN IF PIECES FELL INSIDE THE PATIENT. THE PROCEDURE WAS PERFORMED, WITHOUT ANY DELAY, USING A S+N BACK-UP DEVICE. SINCE INCIDENT OCCURRED BEFORE PROCEDURE; PATIENT WAS NOT YET INVOLVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19121813 ↗
• MalfunctionApr 9, 2024Fracture; Fracture

  IT WAS REPORTED THAT DURING A THA CASE, THE THREADS OF THE PLASTIC TIP OF THE FEMORAL HEAD/NECK IMPACTOR FRACTURED DURING IMPACTION. NO PIECES FELL IN THE PATIENT. STAFF CHECKED THE PATIENT VERY THOROUGHLY TO CONFIRM NO PIECES FELL IN 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 19069585 ↗
• MalfunctionFeb 20, 2024Fracture; Fracture

  IT WAS REPORTED THAT, DURING A THR SURGERY, THE TIP OF A FEMORAL HEAD/NECK IMPACTOR CRACKED WHILE APPLYING FORCE TO THE FEMORAL HEAD. NONE OF THE MATERIAL THAT FELL IN WAS LEFT IN THE PATIENT. THE PROCEDURE WAS COMPLETED, 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 18743366 ↗
• MalfunctionDec 19, 2023Fracture; Fracture

  IT WAS REPORTED THAT DURING A THR SURGERY, IN ONE (1) FEMORAL HEAD/NECK IMPACTOR, THE BLACK TIP IMPACTOR FRACTURED AFTER IMPACTING HEAD. NO PIECES FELL INTO 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 18357771 ↗
• MalfunctionDec 12, 2023Fracture; Fracture

  IT WAS REPORTED THAT DURING A THA SURGERY, IN ONE (1) FEMORAL HEAD/NECK IMPACTOR, THE BLACK PLASTIC IMPACTOR TIP WAS FRACTURED DURING USE. APPROXIMATELY A DIME SIZE PIECE OF THE IMPACTOR TIP BROKE OFF DURING USE. ALL PIECES WERE REMOVED WITH FORCEPS. 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 18313005 ↗
• MalfunctionOct 17, 2023Fracture; Fracture

  IT WAS REPORTED THAT, DURING A THR, WHILE IMPACTING A FEMORAL HEAD/NECK IMPACTOR THE PLASTIC PIECE BROKE IN HALF. HOWEVER, NO PIECES FELL INTO THE PATIENT. SURGERY WAS RESUMED, WITHOUT ANY DELAY, WITH A SMITH AND NEPHEW BACK-UP DEVICE. NO PATIENT HARM WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17954487 ↗
• MalfunctionOct 16, 2023Fracture; Fracture

  IT WAS REPORTED THAT, DURING THR SURGERY, THE PLASTIC TIP OF A FEMORAL HEAD/NECK IMPACTOR BROKE WHILE PLACING THE FINAL IMPLANTS. ALL OF 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 17940676 ↗
• MalfunctionOct 9, 2023Fracture; Fracture

  IT WAS REPORTED THAT, DURING A THR, THE PLASTIC TIP OF A FEMORAL HEAD/NECK IMPACTOR FRACTURED WHILE IMPACTING THE HEAD. HOWEVER, NO PIECES FELL INTO THE PATIENT. SURGERY WAS RESUMED, WITHOUT ANY DELAY, WITH A SMITH AND NEPHEW BACK-UP DEVICE. NO PATIENT HARM WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17901132 ↗
• MalfunctionAug 22, 2023Fracture; Fracture

  IT WAS REPORTED THAT, DURING A THR SURGERY, THE BLACK PLASTIC TIP OF A FEMORAL HEAD/NECK IMPACTOR BROKE IN HALF DURING IMPACTION OF FEMORAL HEAD, RENDERING THE INSTRUMENT UNABLE. ALL THE PIECES WERE REMOVED. 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 17599112 ↗
• MalfunctionApr 21, 2023Fracture; Fracture

  IT WAS REPORTED THAT, DURING A THR SURGERY, WHILE IMPACTING THE FEMORAL HEAD, A FEMORAL HEAD/NECK IMPACTOR BROKE AT THE PLASTIC TIP. THE PIECE FELL INTO THE PATIENT, BUT THE PIECE WAS RECOVERED. 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 16792391 ↗
• InjuryNov 4, 2022Fracture; Fracture

  IT WAS REPORTED THAT, DURING A THR SURGERY, THE FEMORAL HEAD/NECK IMPACTOR BROKE WHEN IMPACTING THE HEAD. ALL PIECES WERE RETRIEVED FROM THE WOUND. 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 15729316 ↗
• MalfunctionNov 3, 2022Fracture; Fracture

  IT WAS REPORTED THAT DURING THR SURGERY, THE PLASTIC TIP OF (1) FEMORAL HEAD/NECK IMPACTOR BROKE. THE PROCEDURE WAS RESUMED, USING THE SAME DEVICE; HOWEVER, IS UNKNOWN IF THERE WAS A SURGICAL DELAY. PATIENT WAS NOT INJURED AS CONSEQUENCE OF THIS ISSUE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15722317 ↗
• MalfunctionNov 1, 2022Fracture; Fracture

  IT WAS REPORTED THAT, THE TIP OF A FEMORAL HEAD/NECK IMPACTOR 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 15711720 ↗
• MalfunctionOct 26, 2022Fracture; Fracture

  IT WAS REPORTED THAT AFTER A THR, ONE (1) FEMORAL HEAD/NECK IMPACTOR HAD THE BLACK TIP BROKE IN HALF. THE PROCEDURE HAD BEEN COMPLETED, WITHOUT ANY DELAY, USING THE SAME DEVICE. SINCE INCIDENT OCCURRED AFTER PROCEDURE; PATIENT WAS NO LONGER INVOLVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15674651 ↗
• MalfunctionJul 10, 2022Break; Break

  IT WAS REPORTED THAT, DURING A THR SURGERY, THE CAP OF THE FEMORAL HEAD/NECK IMPACTOR BROKE. IT IS UNKNOWN IF ANY PIECES FELL INSIDE OF THE PATIENT. SURGERY WAS RESUMED, WITHOUT ANY DELAY, WITH THE SAME DEVICE. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14973829 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K113789. One submission often covers many models, so check the product and lot details in each record.

• Z-0945-2017 · Nov 15, 2016 · Terminated
  Modular SMF(TM) The Modular SMF(TM) and Modular REDAPT(TM) Hip Systems are indicated for individuals undergoing primary and revision surgery where other treatments or devices have