Trident 509-02-66HRecalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 07613327025200), received between Jul 2, 2018 and Jan 27, 2022 — classified as 2 injuries.

The most frequently reported specific device problem is “Loss of Osseointegration” (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 18, 2026.

Most reported problems

Recent adverse event reports

The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• InjuryJan 27, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT'S LEFT HIP WAS REVISED DUE TO PELVIC DISCONTINUITY. THE PATIENT'S HIP WAS REVISED TO A COMPETITOR HIP. THERE ARE NO ALLEGATIONS AGAINST THE REVISED HEAD AND LINER, THE STEM WAS REVISED IN ORDER TO GAIN ACCESS TO THE JOINT SPACE.

  Patient problems: Insufficient Information

  MAUDE report 13365603 ↗
• InjuryJul 2, 2018Loss of Osseointegration; Loss of Osseointegration

  ON (B)(6) 2016 A REPAIR OF THE NONUNION OF THE RIGHT POSTERIOR COLUMN WAS PERFORMED FOR A DIAGNOSIS OF "RIGHT POSTERIOR COLUMN NONUNION". THE OPERATIVE REPORT DESCRIBES GENERAL ANESTHESIA AND A POSTEROLATERAL APPROACH. THE OPERATIVE REPORT NOTES, "NONUNION SITE PARTIALLY HEALED, DIFFICULT TO MANIPULATE; 6-HOLE PELVIS RECONSTRUCTION PLATE ON THE MEDIAL BORDER OF THE POSTERIOR COLUMN WAS PLACED WITH SIX SCREWS." ONCE THIS WAS COMPLETED THE SECOND PART OF THE SURGICAL PROCEDURE WAS PERFORMED, WHICH WAS REMOVAL OF THE RIGHT ACETABULAR COMPONENT FOR A DIAGNOSIS OF FAILED RIGHT TOTAL HIP ARTHROPLASTY FIXATION OF THE RIGHT ACETABULUM. THE OPERATIVE REPORT NOTED THE ACETABULUM WAS GROSSLY LOOSE AND IT WAS REMOVED AND CHANGED TO A 68 MM BIOMET THREE-PHALANGE CAGE WITH SCREWS AND CANCELLOUS BONE CHIPS, AND CEMENTED DUAL MOBILITY CUP INTO THE CAGE. THE STEM WAS RETAINED AND A STRYKER ADAPTER SLEEVE WAS PLACED AND A PLUS-4 BIOLOX HEAD WAS APPLIED.

  Patient problems: Bone Fracture(s); Injury

  MAUDE report 7655270 ↗