Trident II 702-04-58FRecalls & reported problems

Summary

The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 07613327344028), received between Apr 8, 2020 and Oct 23, 2025 — classified as 6 injuries.

The most frequently reported specific device problem is “Loss of Osseointegration” (2 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 6 most recent of 6 reports, in the reporter's own words as published by the FDA.

• InjuryOct 23, 2025Loss of Osseointegration; Loss of Osseointegration

  THIS PI IS FOR THE REVISION OF THE ORIGINAL STRYKER CONSTRUCT DUE TO LOOSENING AND PELVIC DISCONTINUITY. AS PER PSS IMPLANT REQUEST CASE 100750: PREVIOUSLY INFECTED ACETABULAR DISCONTINUITY TREATED WITH STRYKER GAP 66MM CAGE AND 54 CEMENTED OSTEOREMEDY CUP WITH A 46MM OSTEOREMEDY HEAD. PREVIOUS REVISION FOR LOOSE CUP, NOTED TO HAVE A DISCONTINUITY INTRA-OPERATIVELY AS WELL AS INFECTION, TREATED WITH AN ANTIBIOTIC SPACER PRIOR TO THIS REIMPLANTATION UPDATE: SPOKE TO REP: ORIGINAL SURGERY WAS IN ANOTHER STATE. ORIGINALLY A TRIDENT 2 SHELL WAS IMPLANTED. PER SURGEON, THE PATIENT HAD BEEN OVER-REAMED. THIS AND THE PATIENT'S WEIGHT LED TO THE PELVIC DISCONTINUITY. SHELL WAS REMOVED AND AN ANTIBIOTIC SPACER (CEMENT PLUS A POLY INSERT) WERE PLACED. THE CUSTOM IMPLANT IS THE FINAL STAGE. REP WILL TRY TO OBTAIN USAGE SHEETS FOR PRIMARY AND FIRST REVISION SURGERIES, OTHERWISE CONFIRMED THAT NO FURTHER INFORMATION WILL BE RELEASED BY THE HOSPITAL OR SURGEON.

  Patient problems: Inadequate Osseointegration

  MAUDE report 23369504 ↗
• InjuryDec 19, 2024Unstable; Loss of Osseointegration; Unstable; Loss of Osseointegration

  IT WAS REPORTED THAT THE PATIENT'S LEFT HIP WAS REVISED DUE TO TO MULTIPLE DISLOCATIONS / INSTABILITY. THE SHELL, LINER, SCREWS, AND FEMORAL HEAD WERE REVISED TO A MULTI-HOLE SHELL WITH SCREWS, LINER AND A NEW FEMORAL HEAD. REP CONFIRMED THAT NO FURTHER INFORMATION WILL BE RELEASED BY THE HOSPITAL OR SURGEON.

  Patient problems: Joint Dislocation; Joint Laxity

  MAUDE report 20978699 ↗
• InjuryOct 13, 2023Corroded; Corroded

  IT WAS REPORTED THAT THE PATIENT'S RIGHT HIP WAS REVISED. 2 MONTHS POS-OP, PATIENT COMPLAINT OF INCREASING PAIN. APPROXIMATELY 1 MONTH PRIOR TO REVISION, INCREASED ION LEVELS WERE DETECTED. INTRA-OPERATIVELY, CORROSION WAS NOTED ON THE MDM METAL LINER BETWEEN THE METAL LINER AND THE SHELL.

  Patient problems: Pain

  MAUDE report 17928632 ↗
• InjurySep 13, 2023Migration; Migration

  AS REPORTED: "PLEASE FIND ATTACHED INFORMATION FROM INDEX AND REVISION SURGERIES OF A RIGHT TOTAL HIP. THE REVISION WAS SECONDARY TO DISLOCATION. IT WAS DISCOVERED THAT THE CERAMIC HEAD DISASSOCIATED FROM THE POLY INSERT. ALSO DISCOVERED WAS A CRACK IN THE ACETABULUM AND THE APPEARANCE THAT THE CUP HAD MOVED. IT WAS ALSO DETERMINED THAT THE STEM WAS LOOSE. ALL IMPLANTS WERE REMOVED. A MULTIHOLE CUP WAS IMPLANTED WITH MULTIPLE SCREWS AND AN MDM LINER. THE FEMUR WAS PREPARED FOR AN INSIGNIA STEM AND TRAILED. THE HIP REMAINED GROSSLY UNSTABLE SO IT WAS DECIDED TO LEAVE THE PATIENT WITH A GIRDLESTONE. THE PLAN BEING TO COME BACK AFTER THE CUP HAS HEALED AND PLACE A REST MOD WITH CONSTRAINED LINER. NO FURTHER INFORMATION AVAILABLE FROM THE DOCTOR OR HOSPITAL."

  Patient problems: Bone Fracture(s); Inadequate Osseointegration; Joint Dislocation

  MAUDE report 17735251 ↗
• InjuryNov 15, 2022Detachment of Device or Device Component; Noise, Audible; Detachment of Device or Device Component; Noise, Audible

  IT WAS REPORTED THAT THE PATIENT'S LEFT HIP WAS REVISED. PATIENT REPORTED HEARING A POP IN HIS HIP AND AFTERWARDS, THE HIP STARTED SQUEAKING. IT WAS DETERMINED THAT THE LINER DISSOCIATED FROM THE SHELL, ALLOWING THE FEMORAL HEAD TO RUB INSIDE THE SHELL. INTRA-OPERATIVELY, THE SURGEON COULD NOT DETERMINE WITH CERTAINTY IF ONE OF THE SCREWS WAS PROUD BUT COULD NEITHER LOOSEN NOR TIGHTEN IT AS IT WAS STRIPPED, SO THE SURGEON BURRED THE HEAD DOWN TO BE CERTAIN. THE HEAD AND THE LINER WERE REVISED.

  Patient problems: Ambulation or Postural Difficulties

  MAUDE report 15797071 ↗
• InjuryApr 8, 2020Malposition of Device; Malposition of Device

  IT WAS REPORTED THAT THE PATIENT'S RIGHT HIP WAS REVISED DUE TO RECURRENT DISLOCATIONS OF A COMPETITOR HEAD FROM A LINER. THE PATIENT'S SHELL, 2 SCREWS, AND LINER WERE REVISED TO ANOTHER SHELL AND A LINER OF THE SAME CATALOG NUMBER. THE SURGEON WANTED TO REVISE THE SHELL IN ORDER TO REPOSITION IT. REP PROVIDED PRIMARY AND REVISION USAGE SHEETS AND CONFIRMED THAT NO FURTHER INFORMATION WILL BE RELEASED BY THE HOSPITAL OR SURGEON.

  Patient problems: Injury; Joint Dislocation

  MAUDE report 9938927 ↗