NA 71362806Recalls & reported problems

Summary

The FDA's MAUDE database contains 27 adverse event reports that list this exact device (DI 00885556025147), received between Nov 27, 2020 and Jun 30, 2026 — classified as 2 injuries, 25 malfunctions.

The most frequently reported specific device problem is “Break” (13 reports).

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 27 reports, in the reporter's own words as published by the FDA.

• MalfunctionJun 30, 2026Break

  IT WAS REPORTED THAT, DURING A TOTAL KNEE ARTHROSCOPY (TKA) SURGERY, ONE (1) FEMORAL HEAD IMPACTOR (JAPAN) WAS 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 25669817 ↗
• MalfunctionApr 1, 2026Fracture

  IT WAS REPORTED THAT, DURING A THA SURGERY, THE FINAL HEAD IMPLANTED WAS CHANGED TO A DIFFERENT SIZE. TO EXPLANT THE FIRST HEAD THAT WAS TO BE WASTED, ONE (1) FEMORAL HEAD IMPACTOR (JAPAN) WAS USED TO TAMP OFF THE HEAD. THIS WAS WHEN THE HEAD PUSHER BROKE. THE SURGERY WAS RESUMED, WITHOUT ANY DELAY, WITH A BONE TAMP TO EXTRACT THE OLD HEAD, AND ALSO TO IMPACT THE NEW HEAD. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24755346 ↗
• MalfunctionMar 14, 2026Fracture

  IT WAS REPORTED THAT DURING A THA SURGERY, THE TIP OF ONE (1) FEMORAL HEAD IMPACTOR (JAPAN) BROKE WHILE TRYING TO REDUCE THE HIP. THE ITEM BROKE IN TWO COMPLETE PIECES. THE HOSPITAL STAFF DISPOSED OF THE TWO PIECES. NO PARTS WERE LEFT ANYWHERE IN PATIENT ANATOMY. 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 24600301 ↗
• MalfunctionAug 6, 2025Fracture; Fracture

  IT WAS REPORTED THAT, DURING A THR SURGERY, WHILE IMPACTING, THE THREADED TIP OF ONE (1) FEMORAL HEAD IMPACTOR (JAPAN) BROKE OFF. THE PROCEDURE WAS RESUMED, AFTER A NON-SIGNIFICANT DELAY, WITH 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 22726967 ↗
• MalfunctionSep 17, 2024Fracture; Fracture

  IT WAS REPORTED THAT DURING THR SURGERY, ON IMPACTION, THE PIECE OF THE FEMORAL HEAD IMPACTOR BROKE OFF. NOTHING LEFT IN THE PATIENT AND ALL PIECES RETRIEVED BY HAND. THE PROCEDURE WAS COMPLETED WITHOUT 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 20242128 ↗
• MalfunctionJul 9, 2024Fracture; Fracture

  IT WAS REPORTED THAT DURING A THR SURGERY, UPON IMPACTION OF THE FINAL HEAD IMPLANT, ONE (1) FEMORAL HEAD IMPACTOR FRACTURED. ALL THE BROKEN PIECES WERE ACCOUNTED FOR AND MANUALLY REMOVED FROM THE PATIENT BY THE SURGEON. THE PROCEDURE 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 19703282 ↗
• MalfunctionJul 1, 2024Fracture; Fracture

  IT WAS REPORTED THAT, WHILE SEATING THE FEMORAL HEAD ONTO THE STEM IN A THR SURGERY, THE PLASTIC TIP OF ONE (1) FEMORAL HEAD IMPACTOR (JAPAN) CRACKED AND FELL INTO THE PATIENT. ALL PIECES WERE RECOVERED AND THROWN AWAY BY HOSPITAL STAFF. 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 19650942 ↗
• MalfunctionOct 30, 2023Break; Break

  IT WAS REPORTED THAT, DURING TKA SURGERY, THE PLASTIC INSERT OF A FEMORAL HEAD IMPACTOR 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 18035956 ↗
• MalfunctionAug 13, 2023Fracture; Fracture

  IT WAS REPORTED THAT DURING A THR SURGERY, THE BLACK PLASTIC TIP OF THE FEMORAL HEAD IMPACTOR (JAPAN) BROKE DURING IMPACTION OF HEAD. ALL PIECES OF THE PLASTIC TIP WERE REMOVED FROM PATIENT BY THE SURGEON'S HAND. 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 17538088 ↗
• MalfunctionJun 16, 2023Fracture; Fracture

  IT WAS REPORTED THAT, DURING A THR SURGERY, A FEMORAL HEAD IMPACTOR (JAPAN) BROKE AT JUNCTION WHERE IT SCREWS TOGETHER. HOWEVER ALL PIECES WERE RETRIEVED. 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 17143412 ↗
• MalfunctionMar 6, 2023Break; Break

  IT WAS REPORTED THAT, DURING THR SURGERY A FEMORAL HEAD IMPACTOR (JAPAN) PUSHER BROKE DURING HIP REDUCTION. THE PROCEDURE WAS RESUMED, WITHOUT ANY DELAY, USING A S+N BACK-UP DEVICE. NO INJURY WAS REPORTED AS A CONSEQUENCE OF THIS PROBLEM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16493021 ↗
• MalfunctionNov 29, 2022Fracture; Fracture

  IT WAS REPORTED DURING SURGERY, THE IMPACTOR HEAD OF ONE (1) FEMORAL HEAD IMPACTOR (JAPAN) BROKE OFF. THE PROCEDURE WAS RESUMED, WITHOUT ANY DELAY, USING A S+N BACK-UP DEVICE. PATIENT WAS NOT INJURED AS CONSEQUENCE OF THIS PROBLEM. 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 15875762 ↗
• MalfunctionNov 21, 2022Fracture; Fracture

  IT WAS REPORTED THAT, DURING A THR SURGERY, THE PLASTIC TIP OF A FEMORAL HEAD IMPACTOR BROKE . 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. 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 15840482 ↗
• MalfunctionSep 9, 2022Break; Break

  IT WAS REPORTED THAT A FEMORAL HEAD IMPACTOR IS BROKEN. IT IS UNKNOWN WHEN THIS WAS NOTICED AND IF THERE WAS A PATIENT INVOLVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15393128 ↗
• MalfunctionSep 5, 2022Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT, DURING TOTAL HIP REPLACEMENT, THE DISTAL PLASTIC TIP OF A FEMORAL HEAD IMPACTOR WAS CRACKED OUTSIDE THE PATIENT. THE SURGEON WAS TRYING TO REMOVE A FEMORAL HEAD IMPLANT AND THE TIP CRACKED. BASED ON THE DESCRIPTION PROVIDED BY THE INITIAL REPORTER, THERE IS NO INFORMATION THAT INDICATES THAT A SEPARATION OF PIECES OCCURRED; HOWEVER, A VISUAL INSPECTION CONFIRMED THE TIP IS MISSING FROM THE HEAD OF THE DEVICE AND WAS NOT RETURNED. IT WAS CONFIRMED THAT NO PIECES FELL INTO THE PATIENT. SURGERY WAS COMPLETED, WITHOUT ANY DELAY, WITH A SMITH & NEPHEW BACK-UP DEVICE INSTEAD. PATIENT WAS NOT INJURED AS CONSEQUENCE OF THIS PROBLEM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15358633 ↗
• MalfunctionAug 28, 2022Fracture; Fracture

  IT WAS REPORTED THAT, DURING THR USING A FEMORAL HEAD IMPACTOR, THE IMPACTOR TIP BROKE. NO PIECES FELL INTO THE PATIENT. THE TREATMENT WAS CONTINUED WITH A SMITH AND NEPHEW BACK-UP DEVICE. NO INJURY TO PATIENT OR DELAY WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15307963 ↗
• MalfunctionJul 1, 2022Fracture; Fracture

  IT WAS REPORTED THAT, THE TIP OF A FEMORAL HEAD IMPACTOR BROKE. AS THIS WAS NOTICE IN A FIELD INSPECTION, NOT PATIENT WAS INVOLVED. THE VISUAL INSPECTION COULD NOT CONFIRM ANY BREAKAGE, ALTHOUGH IT WAS FOUND THAT THE DEVICE SHOWS SIGNS OF WEAR.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14885923 ↗
• MalfunctionJun 5, 2022Break; Break

  IT WAS REPORTED THAT, DURING A THR SURGERY, WHEN SURGEON WAS HITTING WITH THE MALLET THE FEMORAL HEAD IMPACTOR (JAPAN), THE END BROKE OFF. SURGERY WAS RESUMED, WITH A LESS THAN OR EQUAL TO 30 MINUTES DELAY, WITH A SMITH AND NEPHEW BACK-UP DEVICE. PATIENT WAS NOT HARMED. NO FURTHER COMPLICATIONS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14599750 ↗
• MalfunctionMay 31, 2022Fracture; Fracture

  IT WAS REPORTED THAT, DURING TOTAL HIP REPLACEMENT, A FEMORAL HEAD IMPACTOR BROKE INSIDE THE PATIENT UPON IMPACTING. NO PIECES FELL INTO PATIENT, SINCE THE DEVICE REMAINED INTACT. SURGERY WAS RESUMED, WITHOUT ANY DELAY, WITH A SMITH & NEPHEW BACK-UP DEVICE. PATIENT WAS NOT INJURED AS CONSEQUENCE OF THIS PROBLEM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14548620 ↗
• MalfunctionApr 26, 2022Break; Break

  IT WAS REPORTED THAT, THE TIP OF A FEMORAL HEAD IMPACTOR (B)(6) HAD BROKEN IN HALF. IT IS UNKNOWN WHETHER THIS PROBLEM WAS NOTICED IN A SURGICAL ENVIRONMENT OR NOT; THEREFORE, PATIENT INVOLVEMENT HAS NOT BEEN CONFIRMED.

  Patient problems: Insufficient Information

  MAUDE report 14205993 ↗
• MalfunctionApr 19, 2022Break; Break

  IT WAS REPORTED THAT A FEMORAL HEAD IMPACTOR ((B)(6)) IS BROKEN. IT IS UNKNOWN IF THIS HAPPENED DURING SURGERY OR NOT, THEREFORE, PATIENT INVOLVEMENT HAS NOT BEEN CONFIRMED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14140621 ↗
• MalfunctionJan 19, 2022Break; Break

  IT WAS REPORTED THAT A FEMORAL HEAD IMPACTOR BROKE OFF. AS THIS WAS NOTICED UPON FIELD INSPECTION, THERE WAS NOT PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13289826 ↗
• InjuryNov 12, 2021Break; Break

  IT WAS REPORTED THAT, DURING A THR SURGERY, THE FEMORAL HEAD IMPACTOR ((B)(6)) BROKE ON IMPACTION. ALL PIECES WERE RETRIEVED. 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 12804520 ↗
• MalfunctionNov 7, 2021Break; Break

  IT WAS REPORTED THAT, DURING TOTAL HIP REPLACEMENT, A FEMORAL HEAD IMPACTOR BROKE OUTSIDE THE PATIENT. SURGERY WAS RESUMED, WITHOUT ANY DELAY, WITH A SMITH & NEPHEW BACK-UP DEVICE. PATIENT WAS NOT INJURED AS CONSEQUENCE OF THIS PROBLEM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12760409 ↗
• MalfunctionAug 10, 2021Break; Break

  IT WAS REPORTED THAT, DURING THR SURGERY, THE IMPACTOR TIP OF A FEMORAL HEAD IMPACTOR (JAPAN) BROKE. INCIDENT OCCURRED WHILE INSTRUMENT WAS OUTSIDE THE PATIENT. SURGERY WAS RESUMED, WITHOUT ANY DELAY, USING A BACK-UP DEVICE. PATIENT WAS NOT INJURED AS CONSEQUENCE OF THIS PROBLEM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12301919 ↗