Trident 508-11-54ERecalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 04546540432216), received between Jul 12, 2018 and Sep 10, 2026 — classified as 2 injuries, 1 malfunction.

The most frequently reported specific device problem is “Contamination /Decontamination Problem” (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. How this data works · Data updated Oct 13, 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, 2026Loss of Osseointegration

  Patient problems: Inadequate Osseointegration

  MAUDE report 50722465 ↗
• MalfunctionMar 5, 2019Contamination /Decontamination Problem; Contamination /Decontamination Problem

  IT WAS REPORTED THAT THERE WAS A HAIR BETWEEN A LABEL AND A BAG, AND IT WAS DISCARDED. THE PROCEDURE WAS SUCCESSFUL USING OTHER ONE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8390142 ↗
• InjuryJul 12, 2018Insufficient Device Problem Information; Insufficient Device Problem Information

  PER MEDICAL REVIEW: "ON (B)(6) 2015 REDUCTION OF A DISLOCATION OF THE LEFT TOTAL HIP WAS PERFORMED AND CT POST-REDUCTION SHOWED A COMMINUTED FRACTURE OF THE MEDIAL ACETABULAR WALL. ON (B)(6) 2015 A REVISION OF THE LEFT TOTAL HIP ARTHROPLASTY, ACETABULUM, WITH A CAGE AND BONE GRAFT WAS PERFORMED FOR A DIAGNOSIS OF FAILED ACETABULAR COMPONENT AND RECURRENT INSTABILITY."

  Patient problems: Bone Fracture(s); Injury; Joint Dislocation

  MAUDE report 7683178 ↗