Trident 540-11-48DRecalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 04546540237811), received between Nov 27, 2017 and Sep 13, 2024 — classified as 5 injuries.

The most frequently reported specific device problem is “Insufficient Device Problem Information” (1 report).

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 5 most recent of 5 reports, in the reporter's own words as published by the FDA.

• InjurySep 13, 2024Adverse 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 DUE TO AN ACETABULAR FRACTURE SUSTAINED IN A FALL. THE SHELL, HEAD, AND LINER WERE REVISED TO A SHELL, 6 SCREWS, HEAD AND LINER. REP CONFIRMED THAT THERE WERE NO ALLEGATIONS AGAINST THE REVISED HEAD AND LINER, AND THAT NO FURTHER INFORMATION WILL BE RELEASED BY THE HOSPITAL OR SURGEON.

  Patient problems: Bone Fracture(s)

  MAUDE report 20210380 ↗
• InjuryApr 26, 2023Adverse 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 AFTER INITIAL COMPLAINT OF DISCOMFORT AND CLICKING. SURGEON SUSPECTED CLICKING MAY HAVE BEEN CAUSED BY IMPINGEMENT OF THE STEM AND SHELL. HOWEVER, INTRAOPERATIVELY NO IMPINGEMENT OR CLICKING WERE APPRECIATED BY THE SURGEON. THE SHELL, LINER, AND HEAD WERE REVISED. REP CONFIRMED THAT NO FURTHER INFORMATION WILL BE RELEASED BY THE HOSPITAL OR SURGEON.

  Patient problems: Pain

  MAUDE report 16813047 ↗
• InjuryJun 27, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT LEFT VOICEMAIL ON PATIENT HOTLINE ALLEGING A REQUIRED REVISION AND INQUIRING IF IMPLANTS ARE SUBJECT TO A RECALL.

  Patient problems: Insufficient Information

  MAUDE report 14826740 ↗
• InjuryJan 4, 2021Malposition of Device; Noise, Audible; Malposition of Device; Noise, Audible

  REVISION SURGERY DONE. SURGEON REPORTED THE PATIENT WAS EXPERIENCING "SCRUNCHING" AND "SQUEAKING".

  Patient problems: No Information; Pain

  MAUDE report 11108938 ↗
• InjuryNov 27, 2017Insufficient Device Problem Information; Insufficient Device Problem Information

  DOCTOR REPORTED THAT THE PATIENT HEARD A CRACK FROM HER HIP POST A RIGHT TOTAL HIP. USING CT, IT WAS NOTED THAT THE PATIENT HAD AN ACETABULAR FRACTURE. THE PATIENT SUBSEQUENTLY HEARD A SECOND CRACK WHICH X-RAY REVEALED TO BE A PERI-PROSTHETIC FEMUR FRACTURE. THE DOCTOR DECIDED TO REVISE THE HIP USING SCREWS IN THE ACETABULAR CUP AND A RESTORATION MODULAR HIP STEM AND CABLE FOR THE FEMORAL PROSTHESIS. THE CUP WAS REMOVED AND REPLACED WITH A CLUSTER CUP AND SCREWS. THE FEMORAL COMPONENT WAS REMOVED AND A RESTORATION MODULAR HIP STEM WAS IMPLANTED PER SURGICAL PROTOCOL. CABLES WERE APPLIED AND A TRIAL REDUCTION WAS PERFORMED. THE FINAL IMPLANTS WERE IMPACTED. THE SURGERY WAS PERFORMED WITHOUT INCIDENCE.

  Patient problems: Bone Fracture(s); Injury

  MAUDE report 7062307 ↗