Trident II 702-04-48DRecalls & reported problems

Summary

The FDA's MAUDE database contains 19 adverse event reports that list this exact device (DI 07613327343861), received between Mar 14, 2019 and May 6, 2026 — classified as 18 injuries, 1 malfunction.

The most frequently reported specific device problem is “Insufficient Device Problem Information” (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 19 most recent of 19 reports, in the reporter's own words as published by the FDA.

• InjuryMay 6, 2026Fracture

  THE FOLLOWING INFORMATION WAS PROVIDED: IT WAS REPORTED VIA PHONE; I'M CALLING IN REFERENCE TO A STRYKER TITANIUM TO ACETABULAR CUP MODEL: 702-04-408-D, LOT NUMBER: 23670251A AS IN APPLE AND I WOULD LIKE TO VERIFY WHETHER THIS LOT HAS BEEN INCLUDED IN ANY RECALL SAFETY NOTICES OR AN INVESTIGATION.PT HAD AN INITIAL TOTAL HIP REPLACEMENT PROCEDURE IN (B)(6) 2024 WITH STRYKER IMPLANTS. PT. STARTED TO EXPERIENCE PAIN WITHIN MONTHS AFTER THE PROCEDURE. RECEIVED SHOTS FOR THE PAIN AND HAD 2 ER VISITS AS A RESULT OF THE PAIN. A CAT SCAN REVEALED A FRACTURE. REVISION WAS PERFORMED FOR MECHANICAL FAILURE. HAD AN MRI WHICH CONFIRMED THAT THE IMPLANTS HAD FAILED. CHANGED ACETABULAR CUP AND V-40 BALL DURING REVISION. HAS RECEIVED ADVISE FROM LEGAL COUNSEL (HAS NOT RETAINED LEGAL COUNSEL YET) AND HAS FILED A REPORT WITH THE FDA. LEFT HIP. UPDATE PER MEDWATCH MW5185322: DEVICE FAILURE ON (B)(6) 2024, I UNDERWENT A TOTAL LEFT HIP REPLACEMENT USING A STRYKER TRIDENT II TRITANIUM CLUSTERHOLE ACETABULAR SHELL (702-04-48D, LOT 23670251A AT (B)(6) HOSPITAL IN (B)(6). ALTHOUGH I WAS EXPECTED TO BE DISCHARGED THE SAME DAY, I REMAINED HOSPITALIZED FOR FOUR DAYS DUE TO UNCONTROLLED POSTOPERATIVE PAIN REQU

  Patient problems: Pain

  MAUDE report 25091652 ↗
• InjuryJan 23, 2026Malposition of Device

  THE FOLLOWING INFORMATION WAS PROVIDED: CUP, HEAD, LINER REVISION. PATIENT DISLOCATED DUE TO CUP POSITIONING. RIGHT HIP.

  Patient problems: Insufficient Information

  MAUDE report 24159333 ↗
• InjurySep 6, 2024Migration; Migration

  IT WAS REPORTED THE PATIENT'S RIGHT HIP WAS REVISED DUE TO AN ACETABULAR FRACTURE SUSTAINED IN A FALL. THIS IN TURN LED TO SHELL LOOSENING. THE SHELL, 2 SCREWS, HEAD AND LINER WERE REVISED TO A REVISION MULTI-HOLE SHELL, LINER, AND 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: Bone Fracture(s); Inadequate Osseointegration

  MAUDE report 20156271 ↗
• 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 17629972 ↗
• InjuryMar 13, 2023Loss of Osseointegration; Loss of Osseointegration

  REVISION TOTAL RIGHT HIP DUE TO LOOSENING AND MIGRATION OF ACETABULAR SHELL. REPLACED SHELL, LINER, POLY HEAD AND METAL FEMORAL HEAD WITH DIFFERENT MANUFACTURER PRODUCTS. PER RESPONSE: OPERATIVE SIDE WAS - "RIGHT SIDE".

  Patient problems: Inadequate Osseointegration

  MAUDE report 16527973 ↗
• InjuryJan 6, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  AS REPORTED: "PT. PRESENTED WITH PAIN OF THE HIP FOLLOWING THA. DR. OPTED TO REVISE THE SHELL (NOTE: LINER AND HEAD WERE REVISED AS WELL). NO COMPLAINTS FILED AGAINST THE IMPLANTS THEMSELVES." REP CONFIRMED THAT NO FURTHER INFORMATION WILL BE RELEASED BY THE HOSPITAL OR SURGEON.

  Patient problems: Pain

  MAUDE report 16118691 ↗
• InjuryDec 2, 2022Loss of Osseointegration; Loss of Osseointegration

  AS REPORTED: "PATIENT'S RIGHT HIP REVISED TODAY DUE TO LOOSENING. NO OTHER INFO AVAILABLE DUE TO HOSPITAL POLICY." REP CONFIRMED REVISION WAS DUE TO LOOSENING OF THE SHELL. SHELL, 3 SCREWS, POLY LINER, AND FEMORAL HEAD REVISED TO A SHELL, 4 SCREWS, MDM METAL LINER, ADM/ MDM POLY INSERT, AND ANOTHER FEMORAL HEAD. REP CONFIRMED THAT THE LINER WAS CONVERTED DUE TO SURGEON PREFERENCE.

  Patient problems: Inadequate Osseointegration

  MAUDE report 15903514 ↗
• InjuryOct 26, 2022Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED THAT THE PATIENT'S RIGHT HIP WAS REVISED. AS REPORTED: "PATIENT PRESENTED WITH THIGH PAIN. THERE WAS SUSPICION THAT THE STEM WAS LOOSE. LABS WERE ALSO DRAWN AND ELEVATED COBALT LEVEL WAS PRESENT. IN SURGERY IT WAS DETERMINED THAT THERE WERE NO LOOSE IMPLANTS. THE MDM WAS EXCHANGED FOR CERAMIC ON POLY TO ADDRESS THE ELEVATED COBALT LEVEL. NO OTHER INFORMATION IS AVAILABLE FROM THE SURGEON OR HOSPITAL."

  Patient problems: Pain

  MAUDE report 15672252 ↗
• InjuryFeb 9, 2022Malposition of Device; Malposition of Device

  AS REPORTED: "THE SURGEON STATES THAT THE ACETABULAR IMPLANT WAS NOT MEDIALIZED ENOUGH CAUSING THE PATIENT TO BE 1CM LONGER ON THE OPERATIVE SIDE. SURGEON PULLED THE INSIGNIA STEM TO MAKE IT EASIER TO ACCESS AND REVISE CUP POSITION. NOTHING WAS WRONG WITH STEM OR STEM POSITIONING." SPOKE TO REP, WHO CONFIRMED THAT THERE ARE NO ALLEGATIONS AGAINST THE REVISED LINER, HEAD, OR DOME HOLE COVER.

  Patient problems: Insufficient Information; Unequal Limb Length

  MAUDE report 13502441 ↗
• InjuryNov 16, 2021Insufficient Device Problem Information; Insufficient Device Problem Information

  MPS REPORTED ROBOT ISSUES. MPS REPORTED REAMING THROUGH MEDIAL WALL AND OTHER ISSUES. AS REPORTED VIA COMPLAINT FORM: AFTER IMPACTION, 48 CUP WOULD NOT STICK. SURGEON INDICATED THAT POSTERIOR WALL MAY HAVE BEEN REAMED THROUGH. SURGICAL DELAY = 15 MINUTES. CASE COMPLETED MANUALLY. CASE TYPE / APPLICATION: THA 4.0. UPDATE: ADDITIONAL INFORMATION RECEIVED FROM MPS: "THE SURGEON INDICATED THAT SHE DID NOT NOTICE THE POSTERIOR MEDIAL WALL HAVING DAMAGE UNTIL AFTER CUP IMPACTION. ANOTHER SURGEON WHO HELPED HER WITH THE REPAIR/AUGMENT STATED THAT HE BELIEVED IT MAY HAVE BEEN CAUSED DURING CUP IMPACTION IN COMBINATION WITH A THIN MEDIAL WALL AS OPPOSED TO THE REAMING PORTION."

  Patient problems: Insufficient Information

  MAUDE report 12824128 ↗
• InjurySep 30, 2021Unintended Movement; Unintended Movement

  PATIENT HAD A REVISION PROCEDURE OF THEIR LEFT HIP. IT WAS NOTICED THAT THE CUP HAD MOVED DURING THE PATIENT'S 6 WEEK CHECK UP, AND HAD FURTHER MOVED AT THEIR NEXT CHECK UP AND THE PATIENT WAS REPORTING PAIN. SURGEON DECIDED TO REVISE CUP. SURGEON NOTED THAT THE REVISION WAS A RESULT OF THEM NOT REAMING DEEP ENOUGH, OR CUP WASN'T FULL SEATED WHEN THEY HAD IMPACTED. INITIAL PROCEDURE: (B)(6) 2021. REVISION: (B)(6) 2021. LEFT HIP, FEMALE.

  Patient problems: Insufficient Information

  MAUDE report 12554365 ↗
• InjuryJul 12, 2021Loss of Osseointegration; Loss of Osseointegration

  AS REPORTED: "PERFORMED A LEFT HIP ACETABULAR HIP REVISION DUE TO ASEPTIC LOOSENING...NO MORE INFORMATION IS AVAILABLE PER DOCTOR." A SHELL, HEAD, AND LINER WERE REVISED. REP PROVIDED THE PRIMARY IMPLANT SHEET. SPOKE TO REP, WHO CONFIRMED THERE ARE NO ALLEGATIONS AGAINST THE REVISED LINER OR HEAD.

  Patient problems: Inadequate Osseointegration

  MAUDE report 12148692 ↗
• InjuryMay 5, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THIS PI IS FOR THE INTRA-OPERATIVE EVENTS THAT OCCURRED DURING THE REVISION SURGERY: WHILE REMOVING THE ANATO STEM, AN INTRA-OPERATIVE FEMORAL FRACTURE OCCURRED AND WAS TREATED WITH 2 CABLES FROM HOSPITAL INVENTORY AND IMPLANTING A RESTORATION MODULAR STEM CONSTRUCT. WHILE IMPLANTING A 48MM SHELL, THE SHELL PASSED THROUGH THE PATIENT'S ACETABULUM (SURGEON REPORTED THIS WAS DUE TO POOR BONE QUALITY). THE SURGEON WENT TO A 50 MULTIHOLE SHELL WITH 4 SCREWS. THE SCREWS DIDN'T PROVIDE ADEQUATE FIXATION IN THE SURGEON'S OPINION (DUE TO THE PATIENT'S POOR BONE QUALITY), SO THE 50MM SHELL WAS CEMENTED IN INSTEAD. REP PROVIDED THE PRIMARY AND REVISION USAGE SHEETS AND CONFIRMED THAT NO FURTHER INFORMATION WILL BE RELEASED BY THE HOSPITAL OR SURGEON.

  Patient problems: Bone Fracture(s)

  MAUDE report 11776019 ↗
• InjuryMar 2, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT'S RIGHT HIP WAS REVISED. PATIENT COMPLAINED OF A LOT OF PAIN SO SURGEON DECIDED TO PERFORM AN EXPLORATORY REVISION. THE SURGEON NOTED THERE WAS NO INFECTION, AND NO DEVICES WERE LOOSE OR BROKEN. A TRIDENT II TITANIUM 48D CLUSTER SHELL, TRIDENT 32MM LINER, AND 32MM V40 CERAMIC HEAD WERE REVISED TO A LARGER SHELL AND MDM LINER CONSTRUCT. REP CONFIRMED THAT NO FURTHER INFORMATION WOULD BE RELEASED BY THE HOSPITAL OR SURGEON.

  Patient problems: Pain

  MAUDE report 11398158 ↗
• MalfunctionJan 14, 2021Device Difficult to Setup or Prepare; Device Difficult to Setup or Prepare

  IT WAS REPORTED THAT DURING A MAKO THA, THE LINER WOULD NOT LOCK INTO THE TRIDENT II 48MM SHELL. THE LINER WAS REMOVED AND A SECOND LINER (SAME CATALOG #, DIFFERENT LOT) ALSO WOULD NOT LOCK INTO THE SHELL. SURGEON DECIDED TO IMPLANT AN MDM METAL LINER AND ADM/ MDM POLY INSERT INSTEAD, AND ALSO 'DOWN-SIZED' THE STEM TO ACCOMMODATE. THE FIRST 2 LINERS WERE FROM LOANERS. SURGERY WAS COMPLETED WITH A DELAY OF APPROXIMATELY 30 MINUTES. THE STEM NEEDED TO BE CHANGED BECAUSE WE WERE GOING TO USE A 4; WHICH IS A 35MM NECK. HE WAS GOING TO USE A 36MM MINUS HEAD BUT SINCE THE 36MM LINERS WOULD NOT LOCK IN, HE HAD TO DROP DOWN TO A 3 STEM WHICH IS 5MM LESS NECK LENGTH AND USE A PLUS HEAD OPTION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11168884 ↗
• InjurySep 15, 2020Unstable; Unstable

  PATIENT COMPLAINED OF RIGHT HIP WEAKNESS AND FALL (X2) ON (B)(6) 2019. PATIENT STATED THAT THE FALL WAS DUE TO RIGHT HIP WEAKNESS. RADIOGRAPHIC NOTES INDICATES NO LOOSENING, FRACTURE OR SUBSIDENCE. PATIENT NOT REVISED AS OF (B)(6) 2019.

  Patient problems: Insufficient Information

  MAUDE report 10533964 ↗
• InjuryJul 22, 2020Insufficient Device Problem Information; Difficult or Delayed Separation; Insufficient Device Problem Information; Difficult or Delayed Separation

  PRIMARY PROCEDURE, RIGHT HIP. IT WAS REPORTED THAT THE IMPACTOR BOLT BECAME STUCK IN THE SHELL, AND THAT THE IMPACTOR SHEARED OFF WHERE THE HANDLE MEETS THE CURVED PART OF THE IMPACTOR. ALL DEVICES (INCLUDING THE SHELL) WERE REMOVED FROM THE PATIENT AND ANOTHER SHELL WAS IMPLANTED. SURGERY WAS COMPLETED SUCCESSFULLY WITH A DELAY OF APPROXIMATELY 2 MINUTES. REP MAY BE ABLE TO PROVIDE SOME ADDITIONAL PATIENT INFORMATION, OTHERWISE CONFIRMED THAT NO FURTHER INFORMATION WILL BE RELEASED BY THE HOSPITAL OR SURGEON.

  Patient problems: No Clinical Signs, Symptoms or Conditions; No Known Impact Or Consequence To Patient

  MAUDE report 10307934 ↗
• InjuryApr 18, 2019Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IT WAS REPORTED THAT THE PATIENT'S LEFT HIP WAS REVISED 19 DAYS AFTER IMPLANTATION DUE TO THE ACETABULAR SHELL BECOMING DISLOCATED FROM THE PATIENT'S ACETABULUM. POSSIBLE CAUSE OR CONTRIBUTOR FOR DISLOCATION WAS NOT REPORTED TO THE REP. A SHELL, LINER AND FEMORAL HEAD WERE REVISED TO A SHELL WITH SCREWS, LINER, AND FEMORAL HEAD. REP PROVIDED PRE-REVISION X-RAYS, PRIMARY AND REVISION IMPLANT SHEETS AND REPORTED THAT NO FURTHER INFORMATION WILL BE AVAILABLE.

  Patient problems: Injury

  MAUDE report 8527937 ↗
• InjuryMar 14, 2019Malposition of Device; Malposition of Device

  IT WAS REPORTED THAT THE PATIENT'S RIGHT HIP WAS REVISED DUE TO A FEMORAL PERIPROSTHETIC FRACTURE SUSTAINED IN A FALL. ALSO AS A RESULT OF THAT FALL, THE ACETABULAR SHELL SHIFTED. SURGEON REVISED THE ENTIRE CONSTRUCT TO A RESTORATION MODULAR STEM CONSTRUCT, BIOLOX CERAMIC HEAD, MDM/ ADM LINER CONSTRUCT, AND A TRIDENT II SHELL WITH 3 SCREWS. PATIENT'S BONE QUALITY WAS REPORTED AS SOFT/ POOR. REP REPORTED THAT X-RAYS, MEDICAL RECORDS, AND ADDITIONAL INFORMATION ARE NOT AVAILABLE.

  Patient problems: Bone Fracture(s); Fall; Injury

  MAUDE report 8420740 ↗