Trident II 7030-6535Recalls & reported problems

Summary

The FDA's MAUDE database contains 7 adverse event reports that list this exact device (DI 07613327345100), received between Oct 25, 2018 and Nov 25, 2025 — classified as 4 injuries, 3 malfunctions.

The most frequently reported specific device problem is “Fracture” (2 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 7 most recent of 7 reports, in the reporter's own words as published by the FDA.

• InjuryNov 25, 2025Patient Device Interaction Problem; Patient Device Interaction Problem

  RIGHT HIP REVISION. PT. PRESENTED WITH SIGNS OF SCIATIC NERVE IRRITATION FROM AN ACETABULAR SCREW FOLLOWING A THA. DR. OPTED TO REMOVE THE OFFENDING SCREW(S) AND REPLACE THE HEAD AND LINER ALONG WITH A THOUGH IRRIGATION AND DEBRIDEMENT OF SCAR TISSUE. NO COMPLAINTS FILED AGAINST THE COMPONENTS THEMSELVES, NO FURTHER INFO AVAILABLE.

  Patient problems: Neuralgia

  MAUDE report 23644441 ↗
• InjuryAug 28, 2023Migration; Migration

  IT WAS REPORTED THAT THE PATIENT'S LEFT HIP WAS REVISED. AS REPORTED: "ACETABULAR SHELL SHIFTED FROM IMPLANTED POSITION. EXPLANTS ARE BEING RETAINED BY THE FACILITY."

  Patient problems: Insufficient Information

  MAUDE report 17629973 ↗
• InjuryAug 25, 2022Unstable; Unstable

  IT WAS REPORTED THAT THE PATIENT'S RIGHT HIP WAS REVISED DUE TO INSTABILITY. A SHELL, 6 SCREWS, HEAD AND LINER WERE REVISED TO ANOTHER SHELL, LINER, SCREWS, AND HEAD. REP CONFIRMED THAT NO FURTHER INFORMATION WILL BE RELEASED BY THE HOSPITAL OR SURGEON.

  Patient problems: Joint Laxity

  MAUDE report 15294902 ↗
• MalfunctionJul 8, 2022Material Deformation; Material Twisted/Bent; Material Deformation; Material Twisted/Bent

  PRIMARY PROCEDURE, LEFT HIP. IT WAS REPORTED THAT POST-OP X-RAY SHOWED THAT THE SCREW WAS BENT/ CURVED. SCREW WAS NOT BENT OR CURVED WHEN TAKEN OUT OF THE PACKAGING. SURGEON USED 25MM DRILL WITH GUIDE TO DRILL THE PILOT HOLE. PATIENT'S BONE QUALITY UNKNOWN BUT WAS REPORTED AS 'NOT YOUNG, STRONG BONE'. SURGEON DOES NOT HAVE ANY PLAN TO REVISE THE PATIENT. UPDATE PER SALES REP: 35MM SCREW IS BENT.

  Patient problems: Insufficient Information; No Clinical Signs, Symptoms or Conditions

  MAUDE report 14961293 ↗
• InjuryAug 12, 2021Fracture; Loss of Osseointegration; Loosening of Implant Not Related to Bone-Ingrowth; Fracture; Loss of Osseointegration; Loosening of Implant Not Related to Bone-Ingrowth

  AS REPORTED: "REVISED HIP FOR LOOSE CUP. PATIENT CAME WITH LOOSE CUP AND PAIN." PATIENT'S LEFT HIP WAS REVISED. A SHELL, MDM METAL LINER, ADM/ MDM POLY INSERT, AND 2 SCREWS WERE REVISED. REP PROVIDED AN OPERATIVE REPORT FROM THE PRIOR IMPLANTATION AND AN X-RAY. UPDATE 20/JULY/2021 WG: SPOKE TO REP. THERE ARE NO ALLEGATIONS AGAINST THE REVISED MDM METAL LINER OR ADM/ MDM POLY INSERT. THE SHELL HAD SHIFTED THROUGH THE PATIENT'S PELVIS. NO FURTHER INFORMATION WILL BE RELEASED BY THE HOSPITAL OR SURGEON.

  Patient problems: Inadequate Osseointegration; Pain

  MAUDE report 12312017 ↗
• MalfunctionFeb 11, 2019Break; Break

  REVISION OF COMPETITOR DEVICES, LEFT HIP. WHILE IMPLANTING A SCREW THROUGH A TRIDENT II SHELL, THE SCREW BROKE. THE SURGEON HAD USED A 3.3 X 25 DRILL BIT TO PREPARE THE ACETABULUM. 6.5 X 35MM SCREW WAS LESS THAN HALFWAY INTO THE PATIENT. PATIENT REPORTEDLY HAS SCLEROTIC BONE (HARD/ DENSE BONE QUALITY). THE PORTION OF THE SCREW WAS NOT SITTING PROUD AND THE SURGEON DECIDED TO LEAVE THAT PORTION IN THE PATIENT. SURGEON PROCEEDED TO USE A 4.0 X 25 DRILL BIT TO PREPARE THE ACETABULUM, AND WAS ABLE TO IMPLANT 3 SCREWS OF SMALLER LENGTH (6.5 X 20 AND 6.5 X 30MM). REP CONFIRMED THERE WAS NO SURGICAL DELAY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8325060 ↗
• MalfunctionOct 25, 2018Fracture; Fracture

  IT WAS REPORTED THAT THE SCREW BROKE IN HALF DURING INSERTION.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8006232 ↗