Trident II 702-04-50DRecalls & reported problems

Summary

The FDA's MAUDE database contains 14 adverse event reports that list this exact device (DI 07613327344103), received between Jan 2, 2018 and Jul 10, 2026 — classified as 12 injuries, 2 malfunctions.

The most frequently reported specific device problem is “Detachment of Device or Device Component” (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 14 most recent of 14 reports, in the reporter's own words as published by the FDA.

• InjuryJul 10, 2026Detachment of Device or Device Component

  THE FOLLOWING INFORMATION WAS PROVIDED: LEFT-HIP-REVISION PERFORMED BY DR. TODAY. PT. PRESENTED WITH A DISLOCATED LEFT-HIP FROM A STUMBLE AND FALL, FOLLOWING A LEFT-THA (MDM DISLOCATED FROM THE SHELL). DR. OPTED TO PERFORM AN OPEN-REDUCTION AND REVISION OF THE BIOLOX HEAD AND X3 MDM COMPONENTS, "TO ADD MORE STABILITY."

  Patient problems: Fall; Joint Dislocation

  MAUDE report 25777588 ↗
• InjuryJul 31, 2025Detachment of Device or Device Component; Detachment of Device or Device Component

  NO NEW INFORMATION.

  Patient problems: Ambulation or Postural Difficulties; Insufficient Information

  MAUDE report 22673840 ↗
• InjuryFeb 18, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  AS REPORTED: "REV LTHA- CUP REVISION FOR DISLOCATION. ORIGINAL WAS DONE IN DECEMBER AND SHE DISLOCATED ANTERIOR TWICE. HE REVISED THE CUP AND PUT IN MDM." SPOKE TO REP, THE HEAD CAME OUT OF THE LINER. BECAUSE THE HIP WAS A POSTERIOR APPROACH HIP AND THE PATIENT DISLOCATED ANTERIORLY, THE SURGEON ALSO DECIDED TO REVISE THE SHELL. REP CONFIRMED THAT NO FURTHER INFORMATION WILL BE RELEASED BY THE HOSPITAL OR SURGEON.

  Patient problems: Joint Dislocation

  MAUDE report 21392837 ↗
• InjuryJul 26, 2024Device Dislodged or Dislocated; Device Dislodged or Dislocated

  THIS PI IS FOR REVISION ON (B)(6) 2023.PATIENT HAD AN INDEX LEFT THA ON (B)(6) 2023. PATIENT PRESENTED WITH INSTABILITY AND DISLOCATED THE LEFT HIP ON (B)(6) 2023, UNDERWENT A CLOSED REDUCTION. ON (B)(6) 2023. THE PATIENT PRESENTED WITH ANOTHER DISLOCATION EVENT, AND WAS REVISED, WITH HEAD AND LINER EXCHANGE ONLY. THE PATIENT HAS ANOTHER DISLOCATION EVENT AND IS REVISED AGAIN ON (B)(6) 2023. CUP, LINER, AND HEAD WERE EXCHANGED TO DUAL MOBILITY CONSTRUCT.

  Patient problems: Joint Dislocation

  MAUDE report 19836772 ↗
• InjuryFeb 28, 2023Material Erosion; Material Erosion

  IT WAS REPORTED BY THE PATIENT'S ATTORNEY AS A RESULT OF A LEGAL CLAIM THAT ALLEGEDLY ON OR ABOUT (B)(6) 2019, THE PATIENT UNDERWENT A RIGHT TOTAL HIP REPLACEMENT WITH STRYKER COMPONENTS. IT IS FURTHER ALLEGED THAT THREE MONTHS AFTER THE RIGHT HIP REPLACEMENT, THE PLAINTIFF BEGAN TO EXPERIENCE CLICKING OF THE JOINT, ALONG WITH PAIN IN HER HIP, GROIN AND BUTTOCK AREA. BLOOD TEST REVEALED ELEVATED CHROMIUM (1.0) AND COBALT (7.3) LEVELS AS WELL AS ELEVATED ESR (9) AND CRP (2.8) LEVELS. ALLEGEDLY THE PATIENT WAS REVISED ON AN UNKNOWN DATE.

  Patient problems: Foreign Body Reaction; Metal Related Pathology; Pain

  MAUDE report 16452314 ↗
• InjuryNov 4, 2021Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THE PATIENT'S RIGHT HIP WAS REVISED. ORIGINAL REASON FOR REVISION WAS DISSOCIATION OF THE LINER FROM THE SHELL. INTRA-OPERATIVELY, THE FOLLOWING WERE NOTED: DEFORMATION OF THE LINER, METALLOSIS DUE TO IMPINGEMENT OF THE STEM ON THE SHELL, AND THE SURGEON REPORTED THE STEM WAS TOO SMALL FOR THE PATIENT'S ANATOMY (REP CONFIRMED THERE ARE NO ALLEGATIONS AGAINST THE FEMORAL STEM'S ACTUAL VS. REPORTED SIZE). THE STEM, HEAD, AND LINER WERE REVISED. REP PROVIDED PRIMARY AND REVISION USAGE AND AN EXPLANT PICTURE, AND CONFIRMED THAT NO FURTHER INFORMATION WILL BE RELEASED BY THE HOSPITAL OR SURGEON.

  Patient problems: Insufficient Information

  MAUDE report 12754749 ↗
• MalfunctionAug 12, 2021Device Difficult to Setup or Prepare; Device Difficult to Setup or Prepare

  PRIMARY PROCEDURE, LEFT HIP. IT WAS REPORTED THAT AFTER IMPLANTING THE LINER, IT WOULD NOT LOCK INTO THE SHELL FULLY AND HAD MICROMOTION. THE LINER WAS REMOVED AND A SECOND ONE WAS IMPLANTED WITH THE SAME RESULT. SURGEON REMOVED THE SHELL AND LINER AND IMPLANTED A NEW SHELL. THE NEW (3RD) LINER LOCKED INTO THE SHELL. INSPECTION OF THE WASTED LINERS SHOWED A THIN PIECE HANGING CIRCUMFERENTIALLY AROUND THE LOCKING MECHANISM. PATIENT WAS IRRIGATED TO ENSURE NO PIECES REMAINED IN THE PATIENT. SURGERY WAS COMPLETED SUCCESSFULLY WITH A DELAY OF APPROXIMATELY 15 MINUTES. REP WAS PRESENT FOR AND WITNESSED TO THE PROCEDURE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12311971 ↗
• InjuryFeb 18, 2021Osseointegration Problem; Osseointegration Problem

  IT WAS REPORTED THAT THE PATIENT'S RIGHT HIP WAS REVISED DUE TO SHELL LOOSENING. A TRIDENT II CLUSTER SHELL AND A LINER WERE REVISED. THERE ARE NO ALLEGATIONS AGAINST THE LINER. REP CONFIRMED HE CAN PROVIDE PRIMARY AND REVISION USAGE SHEETS BUT NO OTHER INFORMATION WOULD BE RELEASED BY THE HOSPITAL OR SURGEON.

  Patient problems: Inadequate Osseointegration

  MAUDE report 11342306 ↗
• InjuryMar 12, 2020Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED THAT THE PATIENT'S LEFT HIP WAS REVISED. THE FOLLOWING WERE REPORTED TO THE REP: ELEVATED COBALT LEVELS, METALLOSIS, INFECTION (CONFIRMED BY PATHOLOGY), PSEUDO-TUMOR, METAL CORROSION AROUND THE RIM OF THE SHELL. REP CONFIRMED IMPINGEMENT WAS NOT A FACTOR. ALL COMPONENTS EXCEPT THE STEM WERE REVISED. THE REP FURTHER REPORTED: AFTER THE HEAD WAS EXPLANTED, BLACK MATERIAL WAS NOTED ON THE TRUNNION. WHILE THE BLACK MATERIAL WAS BEING SCRAPED OFF PREPARATORY TO IMPLANTING A NEW HEAD ON IT, PATHOLOGY CALLED THE OR AND CONFIRMED THE EXISTENCE OF INFECTION. THE ENTIRE CONSTRUCT WAS REVISED (STEM FROM THE PRIMARY, ALL OTHER COMPONENTS FROM PREVIOUS REVISION), AND A SPACER WAS PLACED.

  Patient problems: Inflammation; Injury; Reaction; Unspecified Infection

  MAUDE report 9825430 ↗
• InjuryMar 12, 2020Insufficient Device Problem Information; Insufficient Device Problem Information

  IN COVERING A REVISION OF THE PATIENT'S LEFT HIP ON (B)(6) 2020, THE REP WAS TOLD THE PATIENT HAD A PREVIOUS REVISION 'ABOUT A YEAR AGO' DUE TO DISLOCATION. SURGEON REPORTED PATIENT FACTOR OF "BAD SPINE". IT IS UNKNOWN WHICH DEVICE(S) MAY HAVE DISLOCATED OR DISASSOCIATED, BUT THE SURGEON DID REPORT THAT HE REVISED A 50MM SHELL TO A 52MM SOLID-BACK SHELL. REP WAS NOT PRESENT FOR THE PROCEDURE.

  Patient problems: Injury; Joint Dislocation

  MAUDE report 9824822 ↗
• InjurySep 10, 2019Fracture; Insufficient Device Problem Information; Fracture; Insufficient Device Problem Information

  THIS PI IS FOR THE REVISION OF THE PRIMARY STRYKER IMPLANTS ON (B)(6) 2019. PATIENT HAD A COMPETITOR NAIL IN HER LEFT FEMUR WHICH WAS REVISED TO A STRYKER TOTAL HIP WITH ROBOT NAVIGATION ON (B)(6) 2019. ON (B)(6) 2019, IT WAS DISCOVERED THAT THE PATIENT'S ACETABULUM HAD FRACTURED AT THE POSTERIOR WALL AND POSTERIOR COLUMN. ON 14/AUGUST/2019, THE SURGEON REVISED THE SHELL, 36D 0° POLY LINER, AND BIOLOX 36 +0 HEAD TO A NEW SHELL WITH AN ADM/ MDM LINER CONSTRUCT AND ANOTHER FEMORAL HEAD. REP CONFIRMED THERE ARE NO ALLEGATIONS AGAINST THE LINER OR FEMORAL HEAD. THE RESTORATION MODULAR 23 +0 BODY HAD BEEN REMOVED TO ACCESS THE PATIENT'S ACETABULUM, AND RE-IMPLANTED. POSSIBLE CAUSE OR TIME OF FRACTURE ARE UNKNOWN (OR WHETHER IT WAS PRE- OR POST- MAKO PROCEDURE), BUT DURING THE IMPLANTATION 12/AUGUST/2019, THE SURGEON REPORTED THAT THE SHELL FELT "INCREDIBLY STABLE" AND SAW NO NEED TO IMPLANT SUPPLEMENTAL SCREWS.

  Patient problems: Bone Fracture(s); Injury

  MAUDE report 8980909 ↗
• InjuryAug 29, 2019Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IT WAS REPORTED THAT THE PATIENT'S RIGHT HIP WAS REVISED DUE TO DISASSOCIATION OF THE CONSTRAINED LINER FROM THE ACETABULAR SHELL. SURGEON ELECTED TO REVISE THE SHELL TO CHANGE ITS POSITION, THE CONSTRAINED LINER, AND THE FEMORAL HEAD TO A NEW SHELL WITH AN ECCENTRIC LINER AND HEW HEAD. REP CONFIRMED THERE ARE NO ALLEGATIONS AGAINST THE REVISED FEMORAL HEAD. SURGEON REPORTED THAT A SPINAL FUSION IN THE PATIENT'S HISTORY WAS A CONTRIBUTING FACTOR. REP PROVIDED A PRE-REVISION X-RAY AND USAGE SHEETS FOR ALL PATIENT HIP PROCEDURES, AND REPORTED THAT NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: Injury

  MAUDE report 8944171 ↗
• MalfunctionJun 14, 2019Difficult to Remove; Difficult to Remove

  AS REPORTED: "THE CUP WAS PREPARED FOR IMPLANTING BY THREADING ON THE SMALL MAGNETIC BOLT THAT IS DESIGNED FOR THE TRITANIUM II CUP. AFTER IMPACTING THE CUP, [SURGEON] TRIED TO UNSCREW THE BOLT WITH ZERO SUCCESS. THIS NECESSITATED HIM REMOVING THE IMPLANTED CUP AND ONCE AGAIN ATTEMPTING TO UNSCREW THE BOLT UNSUCCESSFULLY. IT TOOK A FEW STAFF MEMBERS USING VARIOUS INSTRUMENTS TO DISLODGE THE BOLT FROM THE CUP. THE SURGEON INDICATED THAT THE CUP'S DOME HOLE THREADS HAD BEEN COMPROMISED AND ASKED FOR A SECOND CUP OF THE SAME SIZE TO BE OPENED. A DIFFERENT BOLT WAS USED FOR THIS AND THE CUP WAS IMPACTED SUCCESSFULLY".

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8699228 ↗
• InjuryJan 2, 2018Migration or Expulsion of Device; Loss of Osseointegration; Migration or Expulsion of Device; Loss of Osseointegration

  PATIENT RECEIVED A TOTAL HIP REPLACEMENT ON (B)(6) 2017. PATIENT CONTINUED TO HAVE PAIN AND DIFFICULTY AMBULATING. PATIENT UNDERWENT TOTAL HIP REVISION TO FIX GROSS LOOSENING AND SUBSIDENCE OF ALL COMPONENTS.

  Patient problems: Ambulation or Postural Difficulties; Inadequate Osseointegration; Injury; Pain

  MAUDE report 7156904 ↗