Trident 502-01-56FRecalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 07613153073109), received between Aug 29, 2018 and Nov 2, 2020 — classified as 3 injuries.

The most frequently reported specific device problem is “Loss of Osseointegration” (2 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 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• InjuryNov 2, 2020Loss of Osseointegration; Loss of Osseointegration

  IT WAS REPORTED THROUGH THE FILING OF A LAWSUIT THAT ALLEGEDLY THE PATIENT WAS IMPLANTED WITH AN LFIT V40 FEMORAL HEAD AND ACCOLADE II HIP STEM ON (B)(6) 2015 AND WAS REVISED ON (B)(6) 2018. IT IS FURTHER ALLEGED THAT THE POST OPERATIVE DIAGNOSES WAS "FAILED RIGHT TOTAL HIP ARTHROPLASTY SECONDARY TO ADVERSE LOCAL TISSUE REACTION METAL-ON-METAL TRUNNIONS DEBRIS WITH LIKELY ASCEPTIC LOOSING OF THE ACETABULAR COMPONENT".

  Patient problems: Foreign Body Reaction; Inadequate Osseointegration

  MAUDE report 10770301 ↗
• InjuryNov 1, 2018Loss of Osseointegration; Migration; Loss of Osseointegration; Migration

  AS PER REVIEW OF MEDICAL RECORDS: X-RAY DATED (B)(6) 2008 IS AN AP OF THE PELVIS WITH THE LEFT HIP LABELED RIGHT, WHICH IS DISLOCATED WITH A LOOSE ACETABULUM MIGRATED VERTICALLY. X-RAY DATED (B)(6) 2008 IS AN AP OF THE LEFT HIP, POST-OP, DEMONSTRATING A REDUCED TOTAL HIP ARTHROPLASTY WITH A LARGER HEAD, MULTIPLE SCREWS, AND NOMINAL POSITION." THIS PI IS FOR DISLOCATION.

  Patient problems: Injury; Joint Dislocation

  MAUDE report 8030861 ↗
• InjuryAug 29, 2018Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED THAT PATIENT'S RIGHT HIP WAS REVISED DUE TO MULTIPLE DISLOCATIONS AND INSTABILITY. INTRA-OPERATIVELY, SEVERE POLY WEAR WAS NOTED. PATIENT WAS REVISED TO AN ADM/MDM LINER CONSTRUCT WITH A NEW SHELL AND HEAD.

  Patient problems: Injury; Joint Dislocation

  MAUDE report 7828604 ↗