Trident 509-02-58FRecalls & reported problems

Summary

The FDA's MAUDE database contains 8 adverse event reports that list this exact device (DI 07613327025170), received between Mar 24, 2017 and Jun 20, 2022 — classified as 8 injuries.

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

Most reported problems

Recent adverse event reports

The 8 most recent of 8 reports, in the reporter's own words as published by the FDA.

• InjuryJun 20, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  REVISED A CUP AND LINER DUE TO PAIN THE PATIENT HAD. THE ORIGINAL SURGERY WAS (B)(6) 2016 WITH THE ORIGINAL TRITANIUM CUP. IT WAS NOTED ON THE X-RAY THERE APPEARED TO BE A HALO. UPON EXTRACTION SURGEON NOTED THERE WAS MOSTLY FIBROUS INGROWTH. ORIGINAL STEM WAS A MINI STEM.

  Patient problems: Pain

  MAUDE report 14749420 ↗
• InjurySep 8, 2020Loss of Osseointegration; Loss of Osseointegration

  IT WAS REPORTED THAT THE PATIENT'S RIGHT HIP WAS REVISED DUE TO LOOSENING. A SHELL, 3 SCREWS, AND A LINER WERE REVISED TO A SHELL, 6 SCREWS AND A LINER. USAGE SHEETS FOR THE CURRENT AND PREVIOUS SURGERIES WERE PROVIDED. REP CONFIRMED THERE ARE NO ALLEGATIONS AGAINST THE REVISED LINER, AND THAT NO FURTHER INFORMATION WILL BE RELEASED BY THE HOSPITAL OR SURGEON.

  Patient problems: Injury

  MAUDE report 10501231 ↗
• InjuryJan 28, 2020Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IT WAS REPORTED THAT THE PATIENT'S LEFT HIP WAS REVISED DUE TO DISLOCATION OF THE ADM/MDM POLY INSERT FROM THE MDM METAL LINER. THE SURGEON ALSO WANTED TO MEDIALIZE THE ACETABULAR SHELL. THE MDM/ ADM LINER CONSTRUCT, CERAMIC HEAD, SLEEVE (IMPLANTED (B)(6) 2019) AND ACETABULAR SHELL WITH 5 SCREWS (IMPLANTED (B)(6) 2019) WERE REVISED TO A LARGER SHELL, REIMPLANTATION OF THE 5 ORIGINAL SCREWS (REP NOTIFIED SURGEON THAT THIS WAS OFF-LABEL USE), AND FEMORAL HEAD WITH CONSTRAINED LINER. REP CONFIRMED THERE ARE NO ALLEGATIONS AGAINST THE REVISED HEAD AND SLEEVE, AND CONFIRMED THAT NO FURTHER INFORMATION WILL BE AVAILABLE.

  Patient problems: Injury

  MAUDE report 9639815 ↗
• InjuryOct 3, 2018Loss of Osseointegration; Loss of Osseointegration

  IT WAS REPORTED THAT PATIENT'S RIGHT HIP WAS REVISED DUE TO SHELL LOOSENING. A 58MM HEMISPHERICAL SHELL, 4 SCREWS, AND A 40F POLY LINER WERE REVISED TO A 62MM HEMISPHERICAL SHELL WITH 5 SCREWS AND A 40G POLY LINER. THE HEAD AND STEM WERE AND REMAIN COMPETITOR DEVICES.

  Patient problems: Inadequate Osseointegration; Injury

  MAUDE report 7930374 ↗
• InjuryMay 10, 2018Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED THROUGH THE SUBMISSION OF A REVISION IMPLANT SHEET THAT PATIENT'S LEFT HIP WAS REVISED. 5 RESTORATION GAP PLATE SCREWS AND A TRIDENT INSERT WERE IMPLANTED. REVISION WAS FOR PERIPROSTHETIC FRACTURE OF ACETABULUM.

  Patient problems: Bone Fracture(s); Injury

  MAUDE report 7502587 ↗
• InjuryJul 24, 2017Device Dislodged or Dislocated; Adverse Event Without Identified Device or Use Problem; Device Dislodged or Dislocated; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED PATIENT'S LEFT HIP WAS REVISED DUE TO DISLOCATED CONSTRAINED LINER. PATIENT FELL TWO TIMES THAT CAUSED THE DISLOCATED LINER. THE SHELL AND SCREWS WERE ALL REVISED.

  Patient problems: Fall; Injury

  MAUDE report 6736728 ↗
• InjuryMay 26, 2017Device Dislodged or Dislocated; Device Dislodged or Dislocated

  PATIENT UNDERWENT A REVISION OF A RIGHT COMPETITOR ACETABULAR COMPONENT ON (B)(6) 2017. PROCEDURE WAS COMPLETED SUCCESSFULLY AND THE POST OP X-RAYS LOOKED GOOD. THE PATIENT SUBSEQUENTLY FELL OUT OF BED . HE WENT TO THE EMERGENCY ROOM. X-RAYS SHOWED THAT HE WAS DISLOCATED AND THE POSITION OF HIS CUP HAD CHANGED FROM THE POST OP FILMS. HE WAS SCHEDULED FOR A REVISION ON (B)(6). THE OPERATION WAS COMPLETED SUCCESSFULLY.

  Patient problems: Fall; Injury; Joint Dislocation

  MAUDE report 6594790 ↗
• InjuryMar 24, 2017Malposition of Device; Malposition of Device

  REVISION OF A TOTAL HIP DUE TO ACUTE INFECTION AND MALPOSITION OF THE ACETABULAR CUP.

  Patient problems: Ambulation or Postural Difficulties; Injury; Unspecified Infection

  MAUDE report 6433087 ↗