Trident II 702-04-56FRecalls & reported problems

Summary

The FDA's MAUDE database contains 14 adverse event reports that list this exact device (DI 07613327344004), received between Oct 28, 2019 and Mar 4, 2026 — classified as 12 injuries, 2 malfunctions.

The most frequently reported specific device problem is “Loss of Osseointegration” (4 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.

• InjuryMar 4, 2026Failure to Osseointegrate

  DURING RECOVER, CUP LOOSENED IN PATIENT AND REVISION WAS PERFORMED 3 DAYS AFTER PRIMARY MAKO THA.

  Patient problems: Inadequate Osseointegration

  MAUDE report 24505850 ↗
• InjuryDec 17, 2025Degraded; Loss of Osseointegration; Degraded; Loss of Osseointegration

  ADDITIONAL INFORMATION RECEIVED 25-MAR-26, "THE PATIENT WAS BROUGHT TO THE OPERATING ROOM FOR REVISION HIP SURGERY ON (b)(6), 2026 FROM A PRIMARY HIP TO AN FDA AND IRB APPROVED STRYKER COMPASSIONATE USE PSS DEVICE. THE PATIENT'S PELVIS WAS REPORTED AS FRACTURED, AND IT REQUIRED THIS DEVICE ALONG WITH MULTIPLE SCREWS AND A RESTORATION MODULAR FEMORAL HIP STEM TO RESTORE STABILITY TO THE JOINT."

  Patient problems: Bone Fracture(s); Foreign Body Reaction; Inadequate Osseointegration; Metal Related Pathology; Periprosthetic fracture

  MAUDE report 23829962 ↗
• InjuryDec 17, 2025Malposition of Device; Device Dislodged or Dislocated; Malposition of Device; Device Dislodged or Dislocated

  UPDATE: SHELL WAS REVISED DUE TO BEING IMPLANTED IN A POOR POSITION PER THE SURGEON.

  Patient problems: Joint Dislocation

  MAUDE report 23826297 ↗
• InjuryApr 28, 2025Malposition of Device; Malposition of Device

  IT WAS REPORTED THAT THE PATIENT'S LEFT HIP WAS REVISED DUE TO SHELL MALPOSITION (SURGEON REPORTED THAT THE SHELL WAS IMPLANTED IN THAT POSITION). A SHELL WITH 2 SCREWS, MDM METAL LINER, ADM/ MDM POLY INSERT, AND BIOLOX HEAD WERE REVISED TO A MULTI-HOLE SHELL WITH 4 SCREWS, POLY LINER, AND FEMORAL HEAD. REP CONFIRMED THERE WERE NO ALLEGATIONS AGAINST THE REVISED LINER, INSERT AND HEAD, AND THAT NO FURTHER INFORMATION WILL BE RELEASED BY THE HOSPITAL OR SURGEON.

  Patient problems: Insufficient Information

  MAUDE report 21922301 ↗
• InjuryJan 6, 2025Loss of Osseointegration; Loss of Osseointegration

  SUBJECT PRESENTED TO CLINIC ON (B)(6) 24 WITH RIGHT HIP PAIN. X-RAYS AND CT SCANS WERE ORDERED. SUBJECT RETURNED TO CLINIC (B)(6) 2024, WHERE THE CT WAS NOTED TO SHOW THAT THE CUP WAS RETROVERTED AND THERE WAS ALSO LUCENCY AROUND THE SCREW. THE BONE SCAN SHOWED INCREASED ACTIVITY IN THE ACETABULUM. INFECTIVE MARKERS WERE NEGATIVE. FINDINGS INDICATED ASEPTIC LOOSENING OF THE RIGHT ACETABULAR COMPONENT. SUBJECT REQUIRES REVISION SURGERY WHICH MAY ALSO REQUIRE EXTENDED TROCHANTERIC OSTEOTOMY AND REMOVAL OF THE STEM GIVEN THE BONE LOSS ASSOCIATED WITH THE ACETABULAR REMOVAL. REVISION SURGERY IS SCHEDULED FOR (B)(6) 2025.

  Patient problems: Inadequate Osseointegration; Pain

  MAUDE report 21080397 ↗
• InjuryOct 13, 2024Unstable; Unstable

  IT WAS REPORTED THAT THE PATIENT'S LEFT HIP WAS REVISED DUE TO INSTABILITY. INTRA-OPERATIVELY, IMPLANTS WERE NOTED TO BE WELL-FIXED WITH NO SIGNS OF WEAR OR DAMAGE. A SHELL, 2 SCREWS, HEAD AND LINER WERE REVISED TO COMPETITOR ACETABULAR IMPLANTS AND A 28 +8 V40 METAL HEAD. REP CONFIRMED THAT NO FURTHER INFORMATION WILL BE RELEASED BY THE HOSPITAL OR SURGEON.

  Patient problems: Joint Laxity

  MAUDE report 20436154 ↗
• InjurySep 17, 2024Insufficient Device Problem Information; Insufficient Device Problem Information

  PT CALLED AND WANTED TO KNOW IF THE IMPLANTS HAD COBALT / ANY RECALLS. HAD A TOTAL HIP REPLACEMENT A YEAR AGO. ADDITIONAL INFO. 22-8-2024: HIGH COBALT LEVELS.

  Patient problems: Metal Related Pathology

  MAUDE report 20235873 ↗
• InjuryDec 11, 2023Loss of Osseointegration; Adverse Event Without Identified Device or Use Problem; Loss of Osseointegration; Adverse Event Without Identified Device or Use Problem

  AS REPORTED: "PATIENT REPORTED TO CLINIC WITH A LEFT HIP PERIPROSTHETIC JOINT INFECTION AND UNDERWENT REVISION SURGERY." ALL IMPLANTS WERE REMOVED. UPDATE: REVISION OP REPORT INDICATED THAT THE ACETABULAR COMPONENT WAS OBSERVED TO BE LOOSE UPON REMOVAL.

  Patient problems: Inadequate Osseointegration; Unspecified Infection

  MAUDE report 18299618 ↗
• InjuryOct 31, 2023Corroded; Loss of Osseointegration; Corroded; Loss of Osseointegration

  PATIENT LEFT VOICEMAIL ON PATIENT HOTLINE REPORTING A REVISION DUE TO PAIN AND "CORRODED METAL ON METAL" WITH HIS RIGHT STRYKER DUAL MOBILITY HIP. UPDATE: METALLOSIS, OSTEOLYSIS. MY BONE WAS DECOMPOSING. I HAD TO HAVE THE HIP REVISED.

  Patient problems: Ambulation or Postural Difficulties; Fibrosis; Metal Related Pathology; Osteolysis; Pain

  MAUDE report 18044734 ↗
• MalfunctionJan 6, 2023Malposition of Device; Malposition of Device

  PRIMARY PROCEDURE, LEFT HIP. ON 09/DECEMBER/2022, REP WAS MADE AWARE THAT POST-OP X-RAYS FOR A HIP IMPLANTED 24/OCTOBER/2022 SHOW THAT THE SCREW PASSED THROUGH THE SHELL. THE SURGEON DOES NOT PLAN ANY INTERVENTION AS OF THE DATE OF AWARENESS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16111864 ↗
• InjuryJun 20, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  AS REPORTED: "X RAYS DEMONSTRATE FAILED ACETABULAR PROSTHESIS WITH ACETABULAR FRACTURE. NO MECHANISM OF INJURY WAS DESCRIBED BY PATIENT." REP PROVIDED AN X-RAY, EXPLANT PICTURES, AND REVISION USAGE. A SHELL, MDM METAL LINER, ADM/ MDM POLY INSERT, CERAMIC HEAD, AND 2 SCREWS WERE REVISED. REP CONFIRMED THAT THERE ARE NO ALLEGATIONS AGAINST THE REVISED LINER CONSTRUCT OR FEMORAL HEAD. NO FURTHER INFORMATION WILL BE RELEASED BY THE HOSPITAL OR SURGEON.

  Patient problems: Bone Fracture(s)

  MAUDE report 14748368 ↗
• InjurySep 20, 2021Insufficient Device Problem Information; Insufficient Device Problem Information

  AS REPORTED: "REVISION OF LEFT ACETABULAR COMPONENT. SURGEON STATES PATIENT IS PHYSICALLY ACTIVE AND PRESENTED WITH PAIN AND FRACTURE OF ACETABULUM. SURGEON STATES SIGNIFICANT ADVERSE LOCAL TISSUE REACTION NOTED DURING SURGERY. SURGEON STATES CUP WAS WELL FIXED." SPOKE TO REP. REP CONFIRMED PATIENT IS VERY PHYSICALLY ACTIVE (WATERSKIING, 72-HOLE GOLF, GYM, ETC). INTRA-OPERATIVELY, THE SURGEON CONFIRMED THAT THE MDM METAL LINER WAS WELL FIXED AND WELL POSITIONED IN THE SHELL. SURGEON ALSO CONFIRMED THERE WAS NO IMPINGEMENT ON THE FEMORAL STEM, AND COULD NOT PROVIDE ANY POSSIBLE CAUSE OR CONTRIBUTOR TO ALTR. A SHELL WITH DOME HOLE PLUG, MDM METAL LINER, ADM/ MDM POLY INSERT, AND V40 BIOLOX CERAMIC HEAD WERE REVISED. REP CONFIRMED THERE ARE NO ALLEGATIONS AGAINST THE REVISED POLY INSERT OR CERAMIC HEAD. REP PROVIDED IMAGING AND PRIMARY IMPLANT REPORT AND CONFIRMED THAT NO FURTHER INFORMATION WILL BE RELEASED BY THE HOSPITAL OR SURGEON.

  Patient problems: Bone Fracture(s); Pain

  MAUDE report 12495399 ↗
• InjuryOct 7, 2020Insufficient Device Problem Information; Insufficient Device Problem Information

  AS REPORTED: "REVISION RIGHT TOTAL HIP. SURGEON STATED PATIENT HAS HIP PAIN. SURGEON STATES PATIENT COBALT LEVEL IS 30. POSSIBLE METALOSIS.". SPOKE TO REP, A SHELL, MDM METAL LINER, ADM/ MDM POLY INSERT, AND CERAMIC HEAD WERE REVISED. REP PROVIDED EXPLANT PICTURES, CONFIRMED THERE ARE NO ALLEGATIONS AGAINST THE REVISED POLY INSERT AND CERAMIC HEAD, AND CONFIRMED THAT NO FURTHER INFORMATION WILL BE RELEASED BY THE HOSPITAL OR SURGEON.

  Patient problems: Foreign Body Reaction; Pain

  MAUDE report 10640542 ↗
• MalfunctionOct 28, 2019Migration; Migration

  AS REPORTED: "ON (B)(6) 2019, DOCTOR WAS PERFORMING A DIRECT ANTERIOR THA. WHEN IMPLANTING 35MM HEX SCREW THE SCREW PROTRUDED THROUGH THE TRIDENT II TRITANIUM CLUSTERHOLE SHELL. THE SCREW WAS LEFT IN THE PATIENT SINCE THERE WAS NO WAY TO RETRIEVE IT." SPOKE TO REP. AFTER IMPLANTING THE SHELL, SCREW, AND LINER, AN INTRA-OP IMAGE WAS TAKEN SHOWING THE SCREW HAD PASSED COMPLETELY THROUGH THE SHELL. THE LINER HAD TO BE REMOVED, ANOTHER SCREW IMPLANTED, AND ANOTHER LINER IMPLANTED. SURGERY WAS COMPLETED WITH A 10 MINUTE DELAY. REP PROVIDED THE USAGE SHEET AND INTRA-OP IMAGE, AND CONFIRMED THAT NO FURTHER INFORMATION WILL BE RELEASED BY THE HOSPITAL OR SURGEON.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9246434 ↗