Trident II 702-04-54ERecalls & reported problems

Summary

The FDA's MAUDE database contains 26 adverse event reports that list this exact device (DI 07613327344073), received between Feb 20, 2018 and Aug 5, 2026 — classified as 24 injuries, 2 malfunctions.

The most frequently reported specific device problem is “Device Dislodged or Dislocated” (8 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 16, 2026.

Most reported problems

Recent adverse event reports

The 25 most recent of 26 reports, in the reporter's own words as published by the FDA.

• MalfunctionAug 5, 2026Unstable

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50147734 ↗
• InjuryMay 12, 2026Device Dislodged or Dislocated

  THE FOLLOWING INFORMATION WAS PROVIDED: RIGHT HIP REVISION PERFORMED, PATIENT HAD STABILITY ISSUES WITH THE CONSTRUCT AND DISLOCATED. SURGEON REMOVED THE LINER AND PLACED THREE SCREWS TO BETTER ANCHOR THE CUP, THEN PLACED A CONSTRAINED INSERT FOR STABILITY. SIMILARLY, THE HEAD WAS REMOVED AND REPLACED WITH A +8 MM HEAD FOR STABILITY PURPOSES. NO COMPLAINTS FILED AGAINST THE COMPONENTS THEMSELVES, AND NO FURTHER INFORMATION AVAILABLE AT THIS TIME. UPDATE PER REP: THE MDM CONSTRUCT DISLOCATED FROM THE ACETABULAR CUP AND METAL-LINER CONSTRUCT, PROMPTING DR. TO REVISE THE MDM-HIP TO A CONSTRAINED-HIP. THE ADM/MDM CAME OUT OF THE METAL LINER. METAL-LINER DID NOT LEAVE THE CUP, FEMORAL HEAD DID NOT LEAVE THE ADM/MDM.

  Patient problems: Joint Dislocation

  MAUDE report 25147105 ↗
• InjuryJul 9, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  REVISED A HEAD, LINER AND CUP OF A LEFT HIP DUE TO PAIN.

  Patient problems: Pain

  MAUDE report 22459270 ↗
• InjuryApr 22, 2025Unstable; Unstable

  IT WAS REPORTED THAT THE PATIENT'S RIGHT HIP WAS REVISED DUE TO INSTABILITY. A SHELL, SCREW, LINER AND HEAD WERE REVISED TO A SHELL, 6 SCREWS, LINER AND HEAD. REP CONFIRMED THAT 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: Joint Laxity

  MAUDE report 21886768 ↗
• InjuryMar 31, 2025Malposition of Device; Device Dislodged or Dislocated; Malposition of Device; Device Dislodged or Dislocated

  REVISED A LEFT HIP DUE TO DISLOCATION. HE HAD REVISED PREVIOUSLY ON (B)(6) 2024. THIS TIME HE REPLACED THE CUP AND HEAD/LINER. ADDITIONAL INFORMATION PROVIDED BY REP: THE SHELL WAS NOT OPTIMALLY POSITIONED, THAT IS WHY (THE SHELL WAS REVISED). THE INSERT (LARGE HEAD) DISLOCATED FROM THE CUP. THEN DR. TOLD ME WHEN THE SURGEON DID A CLOSED REDUCTION THE SMALL HEAD DISASSOCIATED FROM THE INSERT AT THAT TIME. THE CLOSED REDUCTION WAS APPARENTLY DONE AT (ANOTHER HOSPITAL).

  Patient problems: Joint Dislocation

  MAUDE report 21729547 ↗
• InjurySep 6, 2024Fracture; Fracture

  IT WAS REPORTED THAT THE PATIENT'S RIGHT HIP WAS REVISED. THE FOLLOWING WAS REPORTED BY THE SURGEON: PATIENT HAS POOR BONE QUALITY. A FEMORAL NECK FRACTURE WAS TREATED BY IMPLANTING A THA. AFTER IMPLANTATION, THE PATIENT WAS NON-COMPLIANT AND DEVELOPED A PELVIC FRACTURE WHICH PREVENTED THE SHELL FROM DEVELOPING ANY INGROWTH (OVERALL REPORTED AS ASEPTIC LOOSENING). THE SHELL, SCREWS, LINER AND HEAD WERE REVISED. REP CONFIRMED THERE ARE NO ALLEGATIONS AGAINST THE REVISED LINER AND HEAD, AND THAT NO FURTHER INFORMATION WILL BE RELEASED BY THE HOSPITAL OR SURGEON.

  Patient problems: Bone Fracture(s)

  MAUDE report 20156283 ↗
• InjuryMar 23, 2024Malposition of Device; Malposition of Device

  IT WAS REPORTED THAT THE PATIENT'S RIGHT HIP WAS REVISED DUE TO MULTIPLE DISLOCATIONS OF THE HEAD FROM THE LINER. THE HEAD, LINER, AND SHELL WERE REVISED TO A NEW HEAD, MDM METAL LINER, ADM/ MDM POLY INSERT, AND MULTI-HOLE SHELL. THE SHELL WAS REVISED FOR BETTER POSITIONING (THERE ARE NO ALLEGATIONS THAT THE REVISED SHELL WAS MALPOSITIONED, BUT THE SURGEON WANTED TO ADJUST THE VERSION GIVEN THE NATURE OF REVISION).

  Patient problems: Joint Dislocation

  MAUDE report 18966123 ↗
• InjuryFeb 15, 2024Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IT WAS REPORTED THAT THE PATIENT'S LEFT HIP WAS REVISED DUE TO DISSOCIATION OF THE CONSTRAINED LINER FROM THE SHELL. THE CONSTRAINED LINER, HEAD AND REST MOD PROXIMAL BODY WERE REVISED. THERE ARE NO ALLEGATIONS AGAINST THE REVISED HEAD. REASON FOR REVISING WAS NOT GIVEN TO REP WHEN HOSPITAL STAFF WAS ASKED (NEITHER WERE ANY ALLEGATIONS MADE OR OBSERVED).

  Patient problems: Joint Dislocation

  MAUDE report 18717800 ↗
• InjuryJan 16, 2024Positioning Problem; Positioning Problem

  PATIENT REPORTED A PAINFUL HIP. SURGEON SUSPECTED CUP POSITION. THE CUP WAS REVISED TO A COMPETITIVE COMPANY IMPLANT. A NEW STRYKER SLEEVE AND HEAD WERE PLACED. NO ALLEGATIONS AGAINST THE IMPLANTS WERE MADE. PATIENT REPORTED INDEX OPERATION AS (B)(6) WITHOUT SPECIFIC DAY.

  Patient problems: Pain

  MAUDE report 18517298 ↗
• InjuryMar 2, 2023Malposition of Device; Malposition of Device

  IT WAS REPORTED THAT THE PATIENT'S LEFT HIP WAS REVISED DUE TO RECURRING DISLOCATIONS. SURGEON DECIDED TO REVISE THE SHELL (FOR REPOSITIONING), HEAD AND LINER TO A NEW SHELL, MDM METAL LINER, ADM/ MDM POLY INSERT, AND A NEW HEAD. REP CONFIRMED THAT NO FURTHER INFORMATION WILL BE RELEASED BY THE HOSPITAL OR SURGEON.

  Patient problems: Joint Dislocation

  MAUDE report 16465177 ↗
• InjuryDec 21, 2022Unstable; Unstable

  IT WAS REPORTED THAT THE PATIENT'S RIGHT HIP WAS REVISED AFTER PATIENT COMPLAINT OF PAIN AND INSTABILITY FOLLOWING A FALL. REP CONFIRMED NOTHING WAS OBSERVED LOOSE OR BROKEN INTRA-OPERATIVELY. A WELL-FIXED SHELL AND TWO SCREWS, ELEVATED RIM INSERT AND CERAMIC HEAD WERE REVISED. A PORTION OF A SCREW WHICH HAD BROKEN DURING THE PRIMARY IMPLANTATION WAS LEFT IN THE PATIENT. REP PROVIDED USAGE SHEETS FOR THE PRIMARY AND REVISION AND CONFIRMED THAT NO FURTHER INFORMATION WILL BE RELEASED BY THE HOSPITAL OR SURGEON.

  Patient problems: Fall; Joint Laxity; Pain

  MAUDE report 16022484 ↗
• InjuryOct 18, 2022Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IT WAS REPORTED THAT THE PATIENT'S LEFT HIP WAS REVISED. AS REPORTED: "PT. PRESENTED WITH A DISLOCATED HIP, FOLLOWING A REVISION OF THE SAME HIP ON (B)(6) 2022. HEAD/LINER EXCHANGE, ALONG WITH AN EXTENSIVE I&D, AND TISSUE REARRANGEMENT TO HELP WITH THE PT'S HIP-STABILITY. NO COMPLAINTS FILED AGAINST THE COMPONENTS THEMSELVES, NO FURTHER INFO." SPOKE TO REP. THE CONSTRAINED LINER DISSOCIATED OUT OF THE SHELL. THE CONSTRAINED INSERT AND 22.2 +0 FEMORAL HEAD (IMPLANTED (B)(6) 2022) WERE REVISED TO ANOTHER CONSTRAINED INSERT AND FEMORAL HEAD (SAME CATALOG NUMBERS). THE SHELL (IMPLANTED (B)(6) 2020) WAS NOT REVISED. REP CONFIRMED NO FURTHER INFORMATION WILL BE RELEASED BY THE HOSPITAL OR SURGEON.

  Patient problems: Insufficient Information

  MAUDE report 15624171 ↗
• InjurySep 12, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  AS REPORTED: "DR. PERFORMED AN ACETABULAR REVISION TODAY. PT. PRESENTED WITH COMPLAINTS OF DISCOMFORT IN THE HIP. DR. DETERMINED THE POSITION OF SHELL MIGHT BE CAUSING IRRITATION OF THE PT'S ILIOPSOAS TENDON. DR. OPTED TO REVISE THE ACETABULAR SHELL ALONG WITH THE INSERT AND HEAD OPTIONS. NO COMPLAINTS FILED AGAINST THE IMPLANTS THEMSELVES."

  Patient problems: Discomfort

  MAUDE report 15406561 ↗
• InjuryJul 5, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE FOLLOWING WAS REPORTED: STRYKER CUP, LINER AND SCREW REVISED DUE TO INFECTION. LEFT HIP.

  Patient problems: Unspecified Infection

  MAUDE report 14915166 ↗
• InjuryMar 29, 2022Off-Label Use; Malposition of Device; Device Dislodged or Dislocated; Off-Label Use; Malposition of Device; Device Dislodged or Dislocated

  AS REPORTED: "PATIENT DISLOCATED AND WAS REVISED. CUP WAS REPOSITIONED AND CONVERTED TO AN MDM. NO ALLEGATIONS AGAINST THE IMPLANTS. ORIGINAL USAGE AND REVISION USAGE ATTACHED. NO FURTHER INFORMATION IS AVAILABLE." SPOKE TO REP. THE HEAD HAD DISLOCATED FROM THE LINER. THE ELEVATED RIM LINER AND FEMORAL HEAD WERE REVISED TO A METAL MDM LINER, ADM/ MDM POLY INSERT, AND FEMORAL HEAD WITH SLEEVE. THE SURGEON REMOVED 2 SCREWS FROM THE IN-SITU ACETABULAR SHELL, REPOSITIONED THAT SAME SHELL, REIMPLANTED THE ORIGINAL 2 SCREWS, AND ADDED AN ADDITIONAL SCREW. REP CONFIRMED THAT NO FURTHER INFORMATION WILL BE RELEASED BY THE HOSPITAL OR SURGEON.

  Patient problems: Joint Dislocation

  MAUDE report 13945021 ↗
• InjuryMar 4, 2022Malposition of Device; Insufficient Device Problem Information; Malposition of Device; Insufficient Device Problem Information

  DR. REVISED A LEFT TOTAL HIP ORIGINALLY DONE BY MAKO. THE STEM WAS NOT PUT IN CORRECTLY ORIGINALLY. THE CUP WASN'T FULLY STABLE WHEN ASSESSED. EVERYTHING WAS REPLACED WITH COMPETITOR COMPONENTS. NO ALLEGATIONS AGAINST THE IMPLANTS. UPDATE 10/FEBRUARY/2022 WG: REP PROVIDED THE FOLLOWING RESPONSE WHEN ASKED IF THE SHELL WAS IMPLANTED IN THE POSITION IT WAS FOUND IN, OR IF IT HAD SHIFTED: "THE CUP WAS NOT SHIFTED AND WAS IN THE LOCATION AS PLANNED WITH MAKO. DR. USES A MANUAL REAMER WITH SMALLER SIZES UP THROUGH ONE UNDER, AND THEN USES MAKO FOR ONLY THE FINAL SIZE. IT WAS SUSPECTED THAT WAS THE CAUSE FOR THE CUP POSSIBLY NOT BEING FULLY SEATED AS IT'S POSSIBLE HE MANUALLY REAMED DEEPER THAN MAKO PLAN OR OFF CENTER."

  Patient problems: Ambulation or Postural Difficulties; Insufficient Information

  MAUDE report 13665763 ↗
• InjuryJan 11, 2022Loss of Osseointegration; Loss of Osseointegration

  SPOKE TO REP. PATIENT'S LEFT HIP WAS REVISED DUE TO LOOSENING OF THE SHELL. THE SHELL, LINER, HEAD AND SLEEVE WERE REVISED TO COMPETITOR ACETABULAR COMPONENTS, AND ANOTHER STRYKER HEAD AND SLEEVE. REP CONFIRMED THERE ARE NO ALLEGATIONS AGAINST THE REVISED HEAD, SLEEVE, OR LINER.

  Patient problems: Inadequate Osseointegration

  MAUDE report 13222692 ↗
• InjuryAug 25, 2021Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IT WAS REPORTED THAT THE PATIENT'S LEFT HIP WAS REVISED DUE TO DISSOCIATION OF THE CONSTRAINED LINER FROM THE ACETABULAR SHELL. THE CONSTRAINED LINER AND FEMORAL HEAD WERE REVISED. REP PROVIDED USAGE SHEET FROM THE PRIMARY STRYKER IMPLANTATION AND REVISIONS. REP CONFIRMED THERE ARE NO ALLEGATIONS AGAINST THE REVISED FEMORAL HEAD, AND THAT NO FURTHER INFORMATION WILL BE RELEASED BY THE HOSPITAL OR SURGEON.

  Patient problems: Ambulation or Postural Difficulties

  MAUDE report 12364683 ↗
• InjuryJul 2, 2021Malposition of Device; Malposition of Device

  PATIENTS ACETABULUM WAS REVISED FOR MALPOSITION AND RECURRENT SUBLUXATION DUE TO EXCESSIVE ANTEVERSION. TRIDENT II TRITANIUM CLUSTER SHELL 54MM WAS REPLACED WITH A TRIDENT II TRITANIUM MULTIHOLE 54MM SHELL AND 36MM NEUTRAL LINER. FEMORAL HEAD WAS REPLACED WITH A 36 +5 C-TAPER HEAD AND V40-C-TAPER CONVERSION SLEEVE.

  Patient problems: Joint Dislocation

  MAUDE report 12106080 ↗
• InjuryJan 11, 2021Malposition of Device; Malposition of Device

  DR. REVISED A CUP/LINER/HEAD OF A LEFT TOTAL HIP DUE TO DISLOCATION. ORIGINAL SURGERY WAS ON (B)(6) 2019. HE IMPLANTED ANOTHER PRIMARY CUP ADJUSTING THE CUP POSITION RELATIVE TO THE ORIGINAL AND USED MDM. UPDATE 23/DECEMBER/2020: REP PROVIDED PRIMARY AND REVISION USAGE SHEETS AND REPORTED THAT NO FURTHER INFORMATION IS AVAILABLE FROM THE HOSPITAL OR SURGEON.

  Patient problems: Joint Dislocation

  MAUDE report 11151375 ↗
• InjuryJan 8, 2021Corroded; Corroded

  IT WAS REPORTED THE PATIENT'S LEFT MAKO HIP WAS REVISED DUE TO CORROSION, FLUID BUILDUP, METAL DEBRIS, AND MASSIVE PELVIC OSTEOLYSIS. AN MDM METAL LINER, ADM/ MDM POLY INSERT, AND FEMORAL HEAD OF UNKNOWN COMPOSITION WERE REVISED TO A 40MM X3 INSERT, 40MM CERAMIC HEAD WITH A +4 V40 SLEEVE. THE REPORTING REP (WHO WAS NOT THE REP PRESENT FOR THE REVISION SURGERY) DOES NOT KNOW AT THE TIME OF REPORT WHERE THE CORROSION OCCURRED. UPDATE: "ACCORDING TO DR. (B)(6) THE CORROSION WAS NOTED ON THE BACK OF THE MDM LINER, ON THE INNER SURFACE OF THE ACETABULAR SHELL AND IN THE JOINT FLUID. THE FEMORAL HEAD THAT WAS REVISED WAS DELTA CERAMIC. THE EXPLANTED COMPONENTS WERE RETAINED BY THE PATIENT. I DO NOT HAVE ANY PICTURES OF THE EXPLANTED COMPONENTS AS I WAS NOT PRESENT FOR THE SURGERY."

  Patient problems: Inflammation; Osteolysis

  MAUDE report 11139454 ↗
• InjuryJun 8, 2020Device Dislodged or Dislocated; Device Dislodged or Dislocated

  DR. BROUGHT THE PATIENT BACK FOR DISLOCATION. REMOVED HEAD AND LINER. WENT TO A LARGER HEAD WITH LONGER NECK LENGTH.

  Patient problems: Injury; Joint Dislocation

  MAUDE report 10128036 ↗
• InjuryJun 3, 2019Device Dislodged or Dislocated; Device Dislodged or Dislocated

  REP REPORTED "PATIENT IMPLANTED WITH 10* TRIDENT CONSTRAINED ACETABULAR LINER WITH 22MM/0+ INNER HEAD. LINER DISASSOCIATED FROM SHELL UPON PATIENT TRANSFER FROM SURGICAL TABLE TO HOSPITAL BED, POST ANESTHESIA WAKEUP AND SITE CLOSURE. PATIENT HAD TO BE REINDUCED AND RE-OPENED FOR IMMEDIATE REVISION. CONSTRAINED LINER AND INNER HEAD WERE REVISED TO NEW IMPLANTS; SURGEON REQUESTED THAT PRIMARY IMPLANTS BE INVESTIGATED. UPDATE: "NO ALLEGATIONS AGAINST THE HEAD; SURGEON QUESTION LOCKING MECHANISM." RIGHT SIDE.

  Patient problems: Injury

  MAUDE report 8664408 ↗
• InjuryMar 28, 2019Malposition of Device; Malposition of Device

  IT WAS REPORTED THAT THE PATIENT'S RIGHT HIP WAS REVISED. AS REPORTED BY REP: "PATIENT PRESENTED WITH A DISLOCATED HIP, CUP POSITION WAS DETERMINED TO REQUIRE REVISION". A 54MM TRIDENT II SHELL, 36E LINER, AND 36 -2.5 BIOLOX HEAD WERE REVISED TO A 56MM TRIDENT II SHELL WITH ONE SCREW, MDM/ADM LINER CONSTRUCT, AND 28 +0 BIOLOX HEAD. REP REPORTED THAT NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: Injury; Joint Dislocation

  MAUDE report 8461352 ↗
• InjuryApr 11, 2018Migration or Expulsion of Device; Loss of Osseointegration; Insufficient Device Problem Information; Migration or Expulsion of Device; Loss of Osseointegration; Insufficient Device Problem Information

  AS REPORTED: "PATIENT WITH PRIMARY [LEFT] THA ON (B)(6) 2017. UNDERWENT SUBSEQUENT REVISION FOR MECHANICAL COMPLICATIONS. LYTIC LESIONS BEHIND ACETABULAR COMPONENT AND STEM SUBSIDENCE WERE NOTED ON RADIOGRAPHS BEFORE REVISION. ALL COMPONENTS REVISED".

  Patient problems: Bone Fracture(s); Inadequate Osseointegration; Injury; Pain

  MAUDE report 7420818 ↗