TRIDENT II 709-04-50DRecalls & reported problems

Summary

The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 07613327343953), received between Feb 26, 2020 and Apr 3, 2026 — classified as 6 injuries.

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

• InjuryApr 3, 2026Fracture

  THE FOLLOWING INFORMATION WAS PROVIDED: THE PRIMARY SURGERY WAS CONDUCTED ON (B)(6) 2023. THE REVISION SURGERY FOR A CUP LOOSENING REPLACEMENT WAS CONDUCTED ON (B)(6) 2026, AND DURING WHICH IT IS FOUNDED THAT THE CUP BROKEN AND THE SCREW LOOSENING. THE SCREW HAD COME LOOSE AND WAS CUTTING INTO THE LINER SLIDING SURFACE. THE SURGERY WAS COMPLETED WITH IMPLANTED NON-STRYKER PRODUCTS.

  Patient problems: Insufficient Information

  MAUDE report 24776141 ↗
• InjuryNov 25, 2025Malposition of Device; Device Dislodged or Dislocated; Malposition of Device; Device Dislodged or Dislocated

  REVISION SURGERY DUE TO CUP DISLOCATION WITH SCREW FRACTURE.

  Patient problems: Insufficient Information; Joint Dislocation

  MAUDE report 23642900 ↗
• InjuryAug 12, 2025Loss of Osseointegration; Osseointegration Problem; Loss of Osseointegration; Osseointegration Problem

  NO NEW INFORMATION.

  Patient problems: Inadequate Osseointegration

  MAUDE report 22780526 ↗
• InjuryAug 15, 2023Corroded; Positioning Problem; Noise, Audible; Corroded; Positioning Problem; Noise, Audible

  PATIENT HAD AN INDEX RIGHT THA ON (B)(6) 2021. PATIENT PRESENTED WITH RIGHT HIP PAIN AND SQUEAKING. PATIENT UNDERWENT REVISION ON (B)(6) 2022. SOME CORROSION WAS FOUND ON THE TAPER-HEAD UNION. ALL COMPONENTS WERE EXCHANGED EXCEPT THE FEMORAL STEM.

  Patient problems: Loss of Range of Motion; Pain

  MAUDE report 17553613 ↗
• InjuryJul 3, 2023Malposition of Device; Adverse Event Without Identified Device or Use Problem; Malposition of Device; Adverse Event Without Identified Device or Use Problem

  AS REPORTED: "DR. REVISED A LEFT HIP HE ORIGINALLY DID VIA MAKO TO A COMPETITOR REVISION CUP/CAGE CONSTRUCT AND CHANGED THE HEAD. THIS WAS DUE TO PELVIC FRACTURE DURING THE ORIGINAL SURGERY AND SUBSEQUENT FAILURE POST-OP. DURING THE ORIGINAL SURGERY, DR. NOTICED DURING CUP IMPACTION THE ANTERIOR WALL OF THE ACETABULUM HAD A FRACTURE. THIS IS WHEN HE CHANGED FROM A 48 PRIMARY CUP TO A SZ 50 MULTI-HOLE INTRA-OP. POST-OP HE SAID THE PATIENT COULDN'T WALK AND THEREFORE DECIDED TO REVISE THE CUP SIDE. HE NOTED THE BONE QUALITY WAS VERY POOR. THE REVISION SURGERY HE KEPT THE ORIGINAL EXETER STEM IN PLACE." SPOKE TO REP. REP CONFIRMED THAT ON (B)(6) /2023 THE SIZE 48 SHELL WAS IMPACTED, ACETABULUM FRACTURE WAS NOTED, 48 WAS REMOVED AND A 50 IMPLANTED. 5 DAYS LATER ON (B)(6) 2023, THE 50 SHELL WAS REMOVED AND COMPETITOR ACETABULAR COMPONENTS IMPLANTED. THA 4.1

  Patient problems: Ambulation or Postural Difficulties; Bone Fracture(s)

  MAUDE report 17245872 ↗
• InjuryFeb 26, 2020Malposition of Device; Malposition of Device

  IT WAS REPORTED THE PATIENT'S RIGHT HIP WAS REVISED. AS REPORTED BY REP: "PATIENT REVISED DUE TO DISLOCATION." SPOKE TO REP. THE FEMORAL HEAD CAME OUT OF THE POLY LINER. THE HEAD AND LINER WERE REVISED. THE SHELL AND 2 SCREWS WERE ALSO REVISED TO CHANGE THE SHELL'S POSITIONING.

  Patient problems: Injury; Joint Dislocation

  MAUDE report 9753573 ↗