Trident 540-01-54FRecalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 04546540080806), received between Aug 13, 2021 and Aug 13, 2021 — classified as 1 injury.

1 other recall cover devices cleared under the same FDA submission (K983502); they may or may not involve this specific model.

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 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

• InjuryAug 13, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A COMPLETE EXCHANGE OF THE LEFT HIP ENDOPROSTHESIS DUE TO PRONOUNCED METALLOSIS AND DISCOMFORT, WAS ORIGINALLY REPORTED. SUBSEQUENTLY IT WAS REPORTED THAT THE PATIENT HAS THE SAME ISSUE IN THEIR RIGHT HIP AND REVISION SURGERY WAS PLANNED FOR (B)(6) 2021. DUE TO WEAR, THE FEMORAL HEAD DISLOCATED FROM THE TAPER ON (B)(6) 2021 AND LED TO THE IMMOBILITY OF THE PATIENT. FOR THIS REASON, A TOTAL HIP ARTHROPLASTY HAD TO BE PERFORMED ON (B)(6) 2021. REPLACEMENT OF THE HIP ENDOPROSTHESIS DUE TO A PRONOUNCED METALLOSIS. UPDATE 20-JUL-2021: PER SURGERY REPORT (B)(6) 2021 IMPLANT REVISION: USING THE SOCKET CHISEL, CAREFUL CHISELING IS PERFORMED AROUND THE CUP WHICH IS REMOVED WITHOUT SIGNIFICANT BONE LOSS. OSTEOLYSES ARE NOTED IN THE ACETABULAR BED AND AROUND THE PUBIC BONE AS IS OSTEOLYSIS TO THE DORSOCRANIAL AND DORSA. PER EVALUATION OF THE RETURNED DEVICES, LINER DAMAGE WAS ALSO NOTED WITH SUSPECTED IMPINGEMENT WITH THE FEMORAL STEM. THIS IS FOR THE TRIDENT SHELL (CUP).

  Patient problems: Ambulation or Postural Difficulties; Metal Related Pathology; Osteolysis

  MAUDE report 12319293 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K983502. One submission often covers many models, so check the product and lot details in each record.

• Z-3204-2026 · Jul 30, 2026 · Open, Classified
  TRIDENT 0 POLY INSERT 28mm ID 620-00-28D Orthopaedic implant components manufactured from UHMWPE (polyethylene)