Trident 540-11-56FRecalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 04546540237859), received between Jun 5, 2018 and May 11, 2022 — classified as 4 injuries.

The most frequently reported specific device problem is “Degraded” (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 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• InjuryMay 11, 2022Adverse 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 PSOAS TENDON PAIN. A SHELL (IMPLANTED IN 2012), HEAD AND LINER (BOTH IMPLANTED IN 2013, REPORTED) WERE REVISED TO A LARGER SHELL, MDM METAL LINER, ADM/ MDM POLY INSERT, AND ANOTHER FEMORAL HEAD. REP CONFIRMED THAT NO FURTHER INFORMATION WILL BE RELEASED BY THE HOSPITAL OR SURGEON.

  Patient problems: Pain

  MAUDE report 14350982 ↗
• InjuryNov 23, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  REVISION OF RIGHT TOTAL HIP REPLACEMENT DUE TO TITANIUM ALLERGY.

  Patient problems: Foreign Body Reaction

  MAUDE report 12860359 ↗
• InjuryAug 30, 2021Degraded; Material Frayed; Degraded; Material Frayed

  THE SURGEON IS ASKING HAS THERE BEEN ANY PRODUCT WARNINGS ON THE IMPLANTS AS HE SEES EVIDENCE OF METALLOSIS. UPDATE 1 OCTOBER 2021: THERE ARE SIGNS OF WEAR ON THE TRUNNION OF THE ACCOLADE TZMF STEM EVEN THOUGH IT WAS A COC ARTICULATION. NOTICED WHEN PATIENT REPORTED PAIN AND ON SCANS. REVISION COMPLETED ON (B)(6) 2021.

  Patient problems: Insufficient Information; Pain

  MAUDE report 12384510 ↗
• InjuryJun 5, 2018Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IT WAS REPORTED THAT PATIENT'S RIGHT HIP WAS REVISED AFTER RECURRENT ANTERIOR SUBLUXATION. INTRA-OPERATIVELY, HEMATOMA WAS ADDRESSED. PATIENT WAS REVISED TO A TRIDENT TRITANIUM SHELL WITH SCREWS, ADM/MDM LINER CONSTRUCT, AND CERAMIC HEAD.

  Patient problems: Injury; Joint Dislocation

  MAUDE report 7570135 ↗