Trident II 7030-6525Recalls & reported problems

Summary

The FDA's MAUDE database contains 10 adverse event reports that list this exact device (DI 07613327345001), received between Feb 20, 2018 and Jun 11, 2026 — classified as 6 injuries, 4 malfunctions.

The most frequently reported specific device problem is “Malposition of Device” (3 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 10 most recent of 10 reports, in the reporter's own words as published by the FDA.

• InjuryJun 11, 2026Malposition of Device

  THE FOLLOWING INFORMATION WAS PROVIDED: IT WAS REPORTED THAT THE PATIENT'S RIGHT HIP WAS REVISED DUE TO SHELL MALPOSITION. IT WAS ROTATED DISTALLY, AND MIGRATED THROUGH THE ACETABULAR WALL. NO TRAUMA WAS REPORTED TO THE REP. THE SHELL, SCREWS, HEAD AND INSERT WERE REVISED TO ANOTHER SHELL, EVEN MORE SCREWS, MDM/ ADM LINER, AND FEMORAL HEAD. REP CONFIRMED THERE WERE NO ALLEGATIONS AGAINST THE REVISED LINER AND HEAD, AND THAT NO FURTHER INFORMATION WILL BE RELEASED BY THE HOSPITAL OR SURGEON.

  Patient problems: Insufficient Information

  MAUDE report 25477957 ↗
• InjuryJun 11, 2026Malposition of Device

  THE FOLLOWING INFORMATION WAS PROVIDED: IT WAS REPORTED THAT THE PATIENT'S RIGHT HIP WAS REVISED DUE TO SHELL MALPOSITION. IT WAS ROTATED DISTALLY, AND MIGRATED THROUGH THE ACETABULAR WALL. NO TRAUMA WAS REPORTED TO THE REP. THE SHELL, SCREWS, HEAD AND INSERT WERE REVISED TO ANOTHER SHELL, EVEN MORE SCREWS, MDM/ ADM LINER, AND FEMORAL HEAD. REP CONFIRMED THERE WERE NO ALLEGATIONS AGAINST THE REVISED LINER AND HEAD, AND THAT NO FURTHER INFORMATION WILL BE RELEASED BY THE HOSPITAL OR SURGEON.

  Patient problems: Insufficient Information

  MAUDE report 25477956 ↗
• InjuryJun 11, 2026Malposition of Device

  THE FOLLOWING INFORMATION WAS PROVIDED: IT WAS REPORTED THAT THE PATIENT'S RIGHT HIP WAS REVISED DUE TO SHELL MALPOSITION. IT WAS ROTATED DISTALLY, AND MIGRATED THROUGH THE ACETABULAR WALL. NO TRAUMA WAS REPORTED TO THE REP. THE SHELL, SCREWS, HEAD AND INSERT WERE REVISED TO ANOTHER SHELL, EVEN MORE SCREWS, MDM/ ADM LINER, AND FEMORAL HEAD. REP CONFIRMED THERE WERE NO ALLEGATIONS AGAINST THE REVISED LINER AND HEAD, AND THAT NO FURTHER INFORMATION WILL BE RELEASED BY THE HOSPITAL OR SURGEON.

  Patient problems: Insufficient Information

  MAUDE report 25477778 ↗
• InjuryApr 15, 2025Fracture; Fracture

  DISLOCATION OF THE CUP AND SCREW BREAKAGE OCCURRED. REVISION SURGERY IS PLANNED ON (B)(6) 2025.

  Patient problems: Inadequate Osseointegration; Joint Dislocation

  MAUDE report 21838676 ↗
• MalfunctionOct 26, 2023Fracture; Fracture

  WHILE PERFORMING A PRIMARY TOTAL HIP REPLACEMENT, THE SURGEON DECIDED TO PLACED SCREWS INTO THE ACETABULAR COMPONENT. A 25MM 3.3 DRILL BIT WAS USED, WITH THE APPROPRIATE DRILL GUIDE, TO PREPARE THE SCREW HOLE. AFTER USING THE DEPTH GAUGE, THE SURGEON DECIDED TO IMPLANT A 25MM SCREW, USING THE 6.5 HEX DRIVER ON THE RATCHETING HANDLE. THE MAJORITY OF THE SCREW WAS IMPLANTED INTO THE ACETABULUM, WHEN THE AHEAD OF THE SCREW BROKE OFF OF THE SCREW BODY. THE REMAINING SHANK OF THE SCREW WAS SITTING PROUD TO THE INNER PORTION OF THE ACETABULAR SHELL. THE SURGEON DECIDED TO LEAVE THE BROKEN PORTION OF THE SCREW THAT WAS EMBEDDED IN THE ACETABULUM. THE PATIENT RECEIVED AN INTRA-OPERATIVE X-RAY AND THE SURGICAL TIME WAS EXTENDED AS A DIRECT RESULT OF THIS EVENT. UPDATE PER RESPONSE: "WHILE PERFORMING A PRIMARY TOTAL HIP REPLACEMENT, THE SURGEON DECIDED TO PLACED SCREWS INTO THE ACETABULAR COMPONENT. A 25MM 3.3 DRILL BIT WAS USED, WITH THE APPROPRIATE DRILL GUIDE, TO PREPARE THE SCREW HOLE. AFTER USING THE DEPTH GAUGE, THE SURGEON DECIDED TO IMPLANT A 25MM SCREW, USING THE 6.5 HEX DRIVER ON THE RATCHETING HANDLE. THE MAJORITY OF THE SCREW WAS IMPLANTED INTO THE ACETABULUM, WHEN THE HEAD OF TH

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18009588 ↗
• 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 17629970 ↗
• 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 15294883 ↗
• MalfunctionApr 14, 2022Break

  ATTENDING SURGEON UTILIZED STRYKER SCREW SIZE 6.5 MM LOW DIAMETER AND 25MM LENGTH PROFILE HEX SCREW REF # (B)(4) IN RIGHT ACETABULUM WHEN OPERATING ON RIGHT HIP. AT THIS TIME, HEAD OF THIS SCREW BROKE OFF.

  Patient problems: Insufficient Information

  MAUDE report 14111189 ↗
• MalfunctionNov 18, 2020Material Discolored; Packaging Problem; Material Discolored; Packaging Problem

  PRIMARY THA. IT WAS REPORTED THAT AFTER OPENING THE OUTER STERILE BLISTER, THE CORNER OF THE INNER STERILE PACKET WAS DISCOLORED. THE DEVICE WAS REFUSED BEFORE IT ENTERED THE STERILE FIELD AND ANOTHER SCREW (DIFFERENT LOT) WAS OPENED AND USED TO COMPLETE THE PROCEDURE SUCCESSFULLY WITH NO DELAY. REP RETAINED ALL PACKAGING, PROVIDED THE USAGE SHEET (WHICH DOES NOT SHOW THE WASTED SCREW), CONFIRMED HE WAS PRESENT FOR AND WITNESSED THE PROCEDURE, AND CONFIRMED THAT NO FURTHER INFORMATION WILL BE RELEASED BY THE HOSPITAL OR SURGEON.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 10861066 ↗
• MalfunctionFeb 20, 2018Metal Shedding Debris; Device Operates Differently Than Expected; Metal Shedding Debris; Device Operates Differently Than Expected

  PRIMARY PROCEDURE, RIGHT HIP. IT WAS REPORTED THAT THE SCREW PASSED ENTIRELY THROUGH THE CUP. THE SCREW COULD NOT BE EXTRACTED AND WAS LEFT IN THE PATIENT BUT A METAL SHAVING WAS RETRIEVED FROM THE CUP. THE SURGEON PLACED ANOTHER SCREW IN THE CUP TO PROVIDE FIXATION. NO SURGICAL DELAY WAS CAUSED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7282608 ↗