INSTRUMENT 1440-2011Recalls & reported problems

Summary

The FDA's MAUDE database contains 14 adverse event reports that list this exact device (DI 07613327196245), received between Apr 6, 2018 and Apr 17, 2023 — classified as 1 injury, 13 malfunctions.

The most frequently reported specific device problem is “Difficult to Remove” (5 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 14 most recent of 14 reports, in the reporter's own words as published by the FDA.

• MalfunctionApr 17, 2023Difficult to Remove; Use of Device Problem; Difficult to Remove; Use of Device Problem

  IT WAS REPORTED "CUP IMPACTOR BOLT WAS NOT REMOVED FROM TRIDENT II CUP DURING HIP ARTHROPLASTY OPERATION. THE NEW CUP WAS USED INSTEAD".

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16750884 ↗
• MalfunctionJul 15, 2022Use of Device Problem; Use of Device Problem

  PRIMARY PROCEDURE, LEFT HIP. IT WAS REPORTED THAT THE IMPACTOR BOLT COLD-WELDED TO THE SHELL AND COULD NOT BE REMOVED. THE CONSTRUCT WAS REMOVED AND ANOTHER SHELL WAS IMPLANTED. PROCEDURE COMPLETED SUCCESSFULLY WITH A DELAY OF APPROXIMATELY 10-15 MINUTES.

  Patient problems: Insufficient Information

  MAUDE report 15027548 ↗
• MalfunctionJun 27, 2022Device Difficult to Setup or Prepare; Difficult to Remove; Device Difficult to Setup or Prepare; Difficult to Remove

  PRIMARY PROCEDURE, LEFT HIP. IT WAS REPORTED THAT AFTER THE CUP WAS INSERTED, THE MAGNETIC BOLT WAS COLD WELDED TO THE IMPACTOR AND COULD NOT BE REMOVED AT THE BACK TABLE. SURGERY WAS COMPLETED SUCCESSFULLY WITH NO DELAY. REP REPORTED THAT REPLACEMENT IS NEEDED, AND CONFIRMED THAT NO FURTHER INFORMATION WILL BE RELEASED BY THE HOSPITAL OR SURGEON.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14826744 ↗
• MalfunctionApr 20, 2022Difficult to Remove; Difficult to Remove

  IT HAS BEEN REPORTED "MAGNETIC IMPACT SLEEVE CAN NO LONGER BE DETACHED FROM THE TRIDENT CUP! THEREFORE, BOTH WERE REMOVED AND THE PATIENT WAS IMPLANTED WITH ANOTHER TRIDENT CUP, USING THE SECOND MAGNETIC IMPACT SLEEVE, WHICH WORKED PERFECTLY".

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14160520 ↗
• MalfunctionJan 13, 2022Difficult to Remove; Mechanical Jam; Difficult to Remove; Mechanical Jam

  CUP IMPACTOR BOLT IN DSA INSTRUMENT WAS NOT REMOVED FROM TRIDENT II CUP AFTER IMPACTING WITH CURVED CUP BOLT IMPACTOR DURING CUP INSERTION. THEY WERE NOT SEPARATED EVEN AFTER STERILIZATION. THERE WERE NOT ADDITIONAL ITEMS CAN BE REPLACED, SO THAT THE ITEMS IN OTHER COMPANY WERE USED IN THE CASE. 10 TO 15 MINUTES SURGICAL DELAY OCCUR FOR REPLACING THE PRODUCTS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13248192 ↗
• MalfunctionSep 16, 2021Device Difficult to Setup or Prepare; Device Difficult to Setup or Prepare

  PRIMARY PROCEDURE, LEFT HIP. IT WAS REPORTED THAT THE BOLT BECAME STUCK IN THE SHELL. THE BOLT AND SHELL WERE REMOVED, AND A SECOND BOLT WAS USED WITH A SECOND SHELL. SURGERY WAS COMPLETED SUCCESSFULLY WITH A DELAY OF APPROXIMATELY 5-7 MINUTES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12482528 ↗
• MalfunctionJul 22, 2021Degraded; Fracture; Degraded; Fracture

  PRIMARY PROCEDURE, RIGHT HIP. IT WAS REPORTED THAT AFTER POSITIONING THE SHELL, THE MAGNETIC BOLT CAME AWAY WITH 2 METAL RINGS ON IT. THE RINGS WERE DETERMINED TO BE THE 2 INNERMOST THREADS OF THE DOME HOLE. HOWEVER, AS THE TRIAL THREADED INTO THE SHELL WITHOUT ISSUE, THE SURGEON DECIDED TO LEAVE THE SHELL IN THE PATIENT. PROCEDURE WAS COMPLETED SUCCESSFULLY WITH NO DELAY. REP WAS PRESENT FOR AND WITNESS TO THE PROCEDURE. THE IMPACTOR BOLT AND THE BROKEN THREADS ARE AVAILABLE FOR RETURN. REP CONFIRMED THAT NO FURTHER INFORMATION WILL BE RELEASED BY THE HOSPITAL OR SURGEON.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12209047 ↗
• MalfunctionJun 10, 2021Difficult to Remove; Component Misassembled; Difficult to Remove; Component Misassembled

  PRIMARY PROCEDURE, LEFT HIP. IT WAS REPORTED THAT THE OFFSET CUP INSERTER BECAME STUCK IN THE CUP. THE CONSTRUCT WAS REMOVED AND ANOTHER SHELL IMPLANTED. SURGERY WAS COMPLETED SUCCESSFULLY WITH A DELAY OF APPROXIMATELY 5-10 MINUTES. REP PROVIDED THE USAGE SHEET SHOWING THE WASTED SHELL, AND CONFIRMED THAT NO FURTHER INFORMATION WILL BE RELEASED BY THE HOSPITAL OR SURGEON. UPDATE PER SALES REP ON JUNE 1, 2021: THE PRODUCT IN QUESTION IS THE BOLT 1440-2011.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11974023 ↗
• MalfunctionJun 2, 2021Mechanical Jam; Mechanical Jam

  THE CONNECTION BETWEEN THE BOLT AND THE TRIDENT CUP WAS SO TIGHT. WHEN THE BOLT WAS REMOVED AFTER THE CUP WAS PLACED IN THE BODY, IT TURNED TOGETHER WITH THE CUP. EVENTUALLY IT COULD NOT BE PRESS-FITTED, SO A CEMENT CUP WAS USED INSTEAD.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11918557 ↗
• MalfunctionJan 2, 2020Mechanical Jam; Mechanical Jam

  PRIMARY PROCEDURE, LEFT HIP. IT WAS REPORTED THAT AFTER IMPACTING THE SHELL, THE IMPACTING BOLT WAS COLD-WELDED INTO THE SHELL AND COULD NOT BE REMOVED. THE CONSTRUCT WAS REMOVED AND ANOTHER SHELL IMPLANTED WITH A SCREW. SURGERY WAS COMPLETED SUCCESSFULLY WITH A DELAY OF APPROXIMATELY 10 MINUTES.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9541245 ↗
• MalfunctionJan 1, 2020Mechanical Problem; Mechanical Problem

  PRIMARY PROCEDURE, RIGHT HIP. IT WAS REPORTED THAT THE IMPACTOR BOLT BECAME CROSS-THREADED WHEN IT WAS INSERTED INTO THE CUP. SURGEON CONFIRMED THERE ARE NO ALLEGATIONS AGAINST THE IMPACTOR BOLT OR THE SHELL. THE SHELL WAS IMPLANTED USING A NEW BOLT. THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITH NO SURGICAL DELAY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9537183 ↗
• MalfunctionDec 4, 2019Detachment of Device or Device Component; Difficult or Delayed Separation; Detachment of Device or Device Component; Difficult or Delayed Separation

  IT WAS REPORTED THAT DURING A HIP PROCEDURE, THE BOLT COLD WELDED INTO THE SHELL.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9408820 ↗
• InjurySep 27, 2019Separation Problem; Separation Problem

  WHEN IMPACTING A TRIDENT PSL 50 CUP, THE MAGNETISED OFFSET CUP IMPACTOR BOLT (1440-2011) GOT STUCK IN THE DEFINITIVE CUP & COULDN¿T BE DETACHED. THE SURGEON HAD TO DISLODGE THE CUP, TAKE IT OUT, REAM UP AND IMPLANT A 52 PSL CUP WITH A DIFFERENT IMPACTOR (THE STANDARD TRIDENT CUP IMPACTOR). UPON DISLODGING THE CUP TO TAKE IT OUT, THE ANTERIOR COLUMN FRACTURED. APPROX 5-10 MINUTES SURGICAL DELAY.

  Patient problems: Bone Fracture(s)

  MAUDE report 9131169 ↗
• MalfunctionApr 6, 2018Device Operates Differently Than Expected; Device Operates Differently Than Expected

  A SIZE 48MM CUP WAS OPENED ON THE FIELD BY THE NURSE, ST PUT THE CUP ON THE DA CURVED IMPACTED AND PHYSICIAN INSERTED THE CUP. WHEN THE BOLT WAS ATTEMPTED TO BE REMOVED, IT WOULD NOT GO. THE DOCTOR REMOVED THE CUP AND REPLACED WITH A NEW CUP.

  Patient problems: Injury

  MAUDE report 7404437 ↗