NA 75100855Recalls & reported problems

Summary

The FDA's MAUDE database contains 18 adverse event reports that list this exact device (DI 07611996121889), received between Mar 17, 2020 and May 28, 2026 — classified as 1 injury, 17 malfunctions.

The most frequently reported specific device problem is “Fracture” (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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 18 most recent of 18 reports, in the reporter's own words as published by the FDA.

• MalfunctionMay 28, 2026Fracture

  IT WAS REPORTED THAT, DURING A THA, ONE (1) TRIAL FEMORAL HEAD 36 XS/-3 GOT STUCK IN THE ACETABULAR PORTION. THE SURGEON TRIED TO USE A HOOK TO DISLOCATE THE HIP AND REMOVE THE TRIAL WITHOUT SUCCESS, SO AN OSTEOTOME WAS USED. THE OSTEOTOME SLIDE AND BROKE THE TRIAL HEAD INSIDE THE WOUND. ALL PIECES WERE REMOVED WITH CLAMP AND THE WOUND WAS WASHED WITH PULSEJET 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 25325415 ↗
• MalfunctionMar 30, 2026Fracture

  IT WAS REPORTED THAT, DURING A THR, THE PLASTIC ON THE INNER NECK ADAPTOR OF A TRIAL FEMORAL HEAD 36 XS/-3, WAS BROKEN. IT IS UNKNOWN IF ANY PIECE FELL INSIDE THE PATIENT. SURGERY WAS PERFORMED, WITHOUT ANY DELAY, WITH THE SAME DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24736997 ↗
• MalfunctionFeb 23, 2026Fracture

  IT WAS REPORTED THAT, DURING A THR, ONE (1) TRIAL FEMORAL HEAD 36 XS/-3 BROKE DURING TRIALING. ALL PIECES WERE RETRIEVED FROM THE PATIENT WITH FORCEPS. THE PROCEDURE WAS RESUMED, WITHOUT ANY DELAY, USING AN EQUIVALENT S+N BACK-UP. THE PATIENT HAS RECEIVED X-RAYS WHICH WERE REVIEWED BY THE SURGEON. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24416411 ↗
• MalfunctionFeb 20, 2026Fracture

  IT WAS REPORTED THAT, DURING A THR, THE PLASTIC ON THE INNER NECK ADAPTOR OF TWO (2) TRIAL FEMORAL HEAD 36 XS/-3, WERE BROKEN. IT IS UNKNOWN IF ANY PIECE FELL INSIDE THE PATIENT. SURGERY WAS PERFORMED, WITHOUT ANY DELAY, WITH THE SAME DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24401335 ↗
• MalfunctionDec 24, 2025Fracture; Fracture

  IT WAS REPORTED THAT, DURING A THA, AFTER TRIALING CUP AND HEAD, THE FLANGE INSIDE ONE (1) TRIAL FEMORAL HEAD 36 XS/-3 BROKE OFF. THE PIECE WAS RETRIEVED FROM THE PATIENT BY HAND. 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 23887841 ↗
• MalfunctionDec 10, 2025Fracture; Fracture

  IT WAS REPORTED THAT DURING A THA, THE INSIDE PRONG OF A TRIAL FEMORAL HEAD 36 XS/-3 BROKE OFF. AT THIS TIME, IT IS UNKNOWN IF ANY PIECES FELL INTO 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 23773925 ↗
• MalfunctionJul 30, 2025Fracture; Fracture

  IT WAS REPORTED THAT, DURING A THR SURGERY, THE INNER TAB OF THE TRIAL FEMORAL HEAD 36 XS/-3 BROKE WHILE ATTEMPTING TO REDUCE THE HEAD TRIAL INTO THE LINER SOCKET. THE BROKEN OFF PIECE WAS FOUND AND SUCCESSFULLY RECOVERED QUICKLY. THE PROCEDURE WAS RESUMED, AFTER A NON-SIGNIFICANT DELAY, WITH 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 22669074 ↗
• MalfunctionApr 16, 2024Break; Break

  IT WAS REPORTED THAT, DURING A THR, IT WAS NOTICED THAT THE INSIDE OF ONE (1) TRIAL FEMORAL HEAD 36 XS/-3 WAS BROKEN. 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 19121762 ↗
• MalfunctionDec 1, 2022Fracture; Fracture

  IT WAS REPORTED THAT, DURING A THR, A TRIAL FEMORAL HEAD 36 XS/-3 BROKE. AT THIS TIME, IT IS UNKNOWN IF PIECES FELL INTO THE PATIENT. SURGERY WAS RESUMED, WITH A S+N BACKUP DEVICE. IT IS UNKNOWN IF A DELAY HAPPENED. THE PATIENT WAS NOT HARMED AS A CONSEQUENCE OF THIS PROBLEM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15895232 ↗
• MalfunctionNov 12, 2022Fracture; Fracture

  IT WAS REPORTED THAT DURING A THR, THE INTERNAL PLASTIC LOCKING MECHANISM OF ONE TRIAL FEMORAL HEAD 36 XS/-3 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 15785879 ↗
• MalfunctionOct 27, 2022Fracture; Fracture

  IT WAS REPORTED THAT, DURING THR SURGERY, A TRIAL FEMORAL HEAD 36 XS/-3 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 15685379 ↗
• MalfunctionFeb 28, 2022Break; Break

  IT WAS REPORTED THAT DURING INSTRUMENT INSPECTION ON FACILITY, THE TINE INSIDE OF THE TRIAL FEMORAL HEAD 36 XS/-3 BROKE. NO CASE INVOLVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13620915 ↗
• InjuryFeb 15, 2022Fracture; Fracture

  IT WAS REPORTED THAT, DURING TOTAL HIP REPLACEMENT, A TRIAL FEMORAL HEAD 36 XS/-3 BROKE INSIDE THE PATIENT WHERE IT CONNECTS TO THE NECK TRIAL. NO PIECES FELL IN 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 13537166 ↗
• MalfunctionSep 28, 2021Break; Fracture; Break; Fracture

  IT WAS REPORTED THAT. AFTER A PROCEDURE, THE SCRUB TECH NOTICED THE TRIAL FEMORAL HEAD 36 XS/-3 HAD A PIECE FALL OUT OF IT. THIS HAPPENED AFTER USE IN PATIENT. ONE OF THE FOUR TINES ON THE INSIDE OF THE TRIAL HEAD BROKE OFF. ALL PIECES ACCOUNTED FOR IT DID NOT CAUSE A SURGICAL DELAY. PATIENT WAS NOT INJURED AS CONSEQUENCE OF THIS PROBLEM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12544214 ↗
• MalfunctionJul 1, 2021Break; Break

  IT WAS REPORTED THAT, DURING A THR SURGERY WHILE THE INSTRUMENT WAS OUTSIDE THE PATIENT, THE TRIAL FEMORAL HEAD 36 XS/-3 BROKE. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITHOUT DELAY USING A SMITH AND NEPHEW BACK UP DEVICE. PATIENT WAS NOT HARMED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12102238 ↗
• MalfunctionApr 6, 2021Fracture; Fracture

  IT WAS REPORTED A FIN HAS BROKEN ON THE INSIDE OF THE TRIAL FEMORAL HEAD. THE EVENT OCCURRED DURING PROCEDURE, WHILE OUTSIDE THE PATIENT. NO SURGICAL DELAY OR INJURY TO THE PATIENT WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11617773 ↗
• MalfunctionSep 4, 2020Break; Break

  IT WAS REPORTED THAT DURING PROCEDURE THE FEMORAL HEAD TRIAL WAS FOUND CHIPPED, SCRAPED, AND THE SURGEON MADE A COMMENT ON IT. NOTHING FELL INTO PATIENT, NO DELAY TO PROCEDURE, NO HARM TO PATIENT, ALL PIECES RECOVERED. S+N BACKUP DEVICE AS AVAILABLE.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 10497035 ↗
• MalfunctionMar 17, 2020Break; Break

  IT WAS REPORTED THAT, DURING THA, THE TABS THAT HOLD THE HEAD ON A TRUNNION HAVE SNAPPED OFF WHILE TRIALING. SN BACKUP WAS AVAILABLE. NO DELAY WAS RECORDED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9841896 ↗