Trident 625-0T-36HRecalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 04546540516879), received between Oct 22, 2018 and Jul 1, 2021 — classified as 2 injuries.

The most frequently reported specific device problem is “Crack” (1 report).

1 other recall cover devices cleared under the same FDA submission (P000013); they may or may not involve this specific model.

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

• InjuryJul 1, 2021Material Erosion; Material Erosion

  IT WAS REPORTED THAT THE PATIENT REQUIRED REVISION HIP SURGERY FOLLOWING IDENTIFICATION OF ELEVATED TI LEVELS AND A WORN (TITANIUM SLEEVE PORTION) OF A CERAMIC LINER HAD TO BE REMOVED IN ADDITION TO AN ALUMINA HEAD. IT WAS FURTHER REPORTED THAT THE PATIENT WAS REVISED USING A NEW POLY LINER COUPLED WITH A C TAPER SLEEVE AND DELTA 36MM HEAD.

  Patient problems: Metal Related Pathology

  MAUDE report 12104530 ↗
• InjuryOct 22, 2018Crack; Fracture; Crack; Fracture

  DR. STATED THAT THE CUP HAD SHIFTED CAUSING AN IMPINGEMENT ON THE RIM OF THE CERAMIC CUP WHICH ULTIMATELY RESULTED IN A FRACTURE OF THE CERAMIC. DR. REMOVED THE CERAMIC LINER AND CERAMIC HEAD. AFTER DEBRIDEMENT HE REPLACED WITH A NEW CERAMIC LINER AND CERAMIC HEAD. HE PLACED A V 4TOC TAPER SLEEVE RESULTING IN A FRESH TRUNNION. ITEM NOT EXPLANTED: 6021-0537. LOT 8509002. UPDATE 02/OCTOBER/2018: AS REPORTED IN HOW WAS ISSUE NOTICED: PATIENT PRESENTED WITH PAIN.

  Patient problems: Injury; Pain

  MAUDE report 7990761 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under P000013. One submission often covers many models, so check the product and lot details in each record.

• Z-1703-2009 · Jun 9, 2009 · Terminated
  Trident Acetabular System Surgical Protocol. Instructions for use of hip prosthesis. Literature Number LSP55.