Trident 540-11-46DRecalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 04546540237804), received between Jul 10, 2018 and Aug 8, 2022 — classified as 5 injuries.

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 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.

• InjuryAug 8, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT'S LEFT HIP WAS REVISED DUE TO PAIN. SURGEON REPORTED THAT AFTER PRIMARY IMPLANTATION, PATIENT SUSTAINED AN ACETABULAR FRACTURE IN A MOTOR VEHICLE ACCIDENT AND SUSPECTED SHELL LOOSENING. INTRA-OPERATIVELY, SURGEON REPORTED THAT THE SHELL CAME OUT MORE EASILY THAN EXPECTED. A SHELL, LINER, AND HEAD WERE REVISED. REP CONFIRMED THERE ARE 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); Pain

  MAUDE report 15188292 ↗
• InjuryMar 1, 2022Unstable; Unstable

  PATIENT HAD RIGHT INDEX THA IN (B)(6) 2021. PATIENT PRESENTS WITH INSTABILITY AND RECURRENT DISLOCATION. UNDERGOES REVISION ON (B)(6) 2021 DUE TO LATERAL INSTABILITY ALTHOUGH WELL FIXED CUP. THE CUP, HEAD, AND LINER ARE EXCHANGED.

  Patient problems: Joint Dislocation; Joint Laxity

  MAUDE report 13628582 ↗
• InjuryMar 23, 2020Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED THAT THE PATIENT'S RIGHT HIP WAS REVISED DUE TO PAIN AND WEAKNESS IN THE HIP. THE REP REPORTED THAT THERE WERE NO ALLEGATIONS AGAINST THE IMPLANTS AND THAT PATIENT'S SOFT TISSUE PROBLEMS WERE THE PRIMARY CAUSE. THE PATIENT'S SHELL, HEAD AND LINER WERE REVISED. REP PROVIDED THE SURGEON NOTES, OFFICE VISIT NOTES, AND THE PRIMARY USAGE SHEET AND REPORTED THAT NO FURTHER INFORMATION WILL BE RELEASED BY THE HOSPITAL OR SURGEON.

  Patient problems: Injury; Pain; Weakness

  MAUDE report 9868290 ↗
• InjuryJul 25, 2019Insufficient Device Problem Information; Insufficient Device Problem Information

  POSTOPERATIVE DIAGNOSIS: PATIENT UNDERWENT LEFT HIP REPLACEMENT (B)(6) 2018. PATIENT HAD LEFT TOTAL HIP REVISION THE CUP, FEMORAL HEAD AND LINER WERE REMOVED (B)(6) 2019.

  Patient problems: Injury

  MAUDE report 8826039 ↗
• InjuryJul 10, 2018Insufficient Device Problem Information; Insufficient Device Problem Information

  PATIENT UNDERWENT PRIMARY THA (B)(6) 2017. PATIENT RETURNED COMPLAINING OF PAIN. X-RAYS REVEALED ACETABULAR PERIPROSTHETIC FRACTURE WITH PROTRUSIO OF THE SHELL (B2). UNDERWENT REVISION OF ACETABULUAR CUP AND POLY (OFF-LABEL) AND HEAD.

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

  MAUDE report 7674514 ↗