Trident 500-11-56FRecalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 04546540431882), received between Oct 15, 2018 and Sep 10, 2024 — classified as 3 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 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• InjurySep 10, 2024Loss of Osseointegration; Loss of Osseointegration

  IT WAS REPORTED THROUGH THE FILING OF A LAWSUIT THAT ALLEGEDLY THE PATIENT WAS IMPLANTED WITH AN LFIT ANATOMIC COCR V40 FEMORAL HEAD ON HER RIGHT HIP ON OR ABOUT (B)(6), 2006 AND WAS REVISED ON (B)(6) 2010. IT IS FURTHER ALLEGED THAT SHE SUFFERED INJURIES AS A RESULT OF IMPLANTATION OF THE DEVICE AT ISSUE, DEVICE RECALL, EXCESSIVE LEVELS OF CHROMIUM AND COBALT IN HIS BLOOD. UPDATE AS PER MEDICAL REVIEW: IT WAS FOUND THAT THE ACETABULAR COMPONENT WAS LOOSE AND THERE WAS NO EVIDENCE OF INFECTION OR ANY CORROSION OR TRUNNIONOSIS OR ALTR. THE DIAGNOSIS WAS ASEPTIC LOOSENING.

  Patient problems: Foreign Body Reaction; Inadequate Osseointegration; Metal Related Pathology

  MAUDE report 20182546 ↗
• InjuryJan 25, 2019Osseointegration Problem; Osseointegration Problem

  AS REPORTED: "RIGHT HIP [REVISION], POSSIBLE LOOSE IMPLANTS, HIP PAIN". A 56 TRIDENT SHELL, 36MM X3 POLY, 36 +2.5 BIOLOX HEAD, AND ACCOLADE II #7 STEM WERE REVISED TO COMPETITOR DEVICES.

  Patient problems: Inadequate Osseointegration; Injury; Pain

  MAUDE report 8277388 ↗
• InjuryOct 15, 2018Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED THAT PATIENT'S LEFT HIP WAS REVISED. PATIENT COMPLAINTS, PRE-REVISION OCCURRENCES OR DIAGNOSES, INTRA-OPERATIVE FINDINGS WERE NOT REPORTED TO THE REP. A SHELL, LINER AND HEAD WERE REVISED TO A COMPETITOR SHELL AND LINER WITH A STRYKER HEAD.

  Patient problems: Injury

  MAUDE report 7967467 ↗