Trident 621-00-36FRecalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 07613327023756), received between Nov 9, 2018 and Aug 13, 2021 — classified as 3 injuries.

The most frequently reported specific device problem is “Device Damaged by Another Device” (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 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• InjuryAug 13, 2021Device Damaged by Another Device; Device Damaged by Another Device

  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 MDR IS FOR THE TRIDENT LINER.

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

  MAUDE report 12319249 ↗
• InjuryJan 24, 2019Device Dislodged or Dislocated; Device Dislodged or Dislocated

  AS REPORTED: "DISLOCATING TOTAL HIP. CONVERTED TO MDM CONSTRUCT".

  Patient problems: Injury; Joint Dislocation; Unspecified Infection

  MAUDE report 8274509 ↗
• InjuryNov 9, 2018Material Deformation; Material Deformation

  HEAD DISASSOCIATION REVISION, TRUNIONOSIS, INFECTED HIP WITH PLACEMENT OF STEM AND ALL POLY CUP. (B)(6) 2018: EXPLANT PHOTOS SHOW TRUNNION DAMAGE AND POLY WEAR.

  Patient problems: Injury; Reaction; Unspecified Infection

  MAUDE report 8054634 ↗