Trident 663-00-36ERecalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 07613327024692), received between Apr 2, 2018 and Oct 12, 2023 — classified as 2 injuries, 1 malfunction.

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

2 other recalls cover devices cleared under the same FDA submission (K033716); 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 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• InjuryOct 12, 2023Device Dislodged or Dislocated; Device Dislodged or Dislocated

  AS REPORTED: "REVISION LTHA COMPLETED TODAY D/T DISLOCATION. FEMORAL HEAD AND LINER WERE REMOVED AND REPLACED WITH MDM AND BIOLOX HEAD." REP CONFIRMED THAT NO FURTHER INFORMATION WILL BE RELEASED BY THE HOSPITAL OR SURGEON.

  Patient problems: Joint Dislocation

  MAUDE report 17918542 ↗
• InjuryMay 26, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT'S RIGHT HIP WAS REVISED DUE TO PATIENT COMPLAINT OF HIP PAIN. A 36 + 2.5 MM CERAMIC V40 HEAD AND 36E 0° ECCENTRIC LINER WERE REVISED TO A 28 + 5MM BIOLOX DELTA C-TAPER HEAD WITH ADAPTER SLEEVE, ADM/MDM INSERT AND MDM LINER. SPOKE TO REP: INTRA-OPERATIVELY, PSEUDO-TUMOR WAS NOTED AROUND THE BONE. IMPLANTS WERE REPORTED AS STABLE. REP CONFIRMED THAT NO FURTHER INFORMATION WOULD BE RELEASED BY THE HOSPITAL OR SURGEON.

  Patient problems: Foreign Body Reaction; Pain

  MAUDE report 11883991 ↗
• MalfunctionApr 2, 2018Break; Break

  PRIMARY PROCEDURE, LEFT HIP. IT WAS REPORTED THAT IN IMPLANTING A POLY LINER, IT WOULDN'T SEAT PROPERLY IN THE SHELL. UPON IMPACTION, A PIECE OF THE LINER SHEARED OFF. SURGEON REMOVED THE LINER AND THE PIECE, VISUALLY INSPECTED, AND IRRIGATED THE PATIENT TO BE SURE ALL MATERIAL WAS REMOVED. ANOTHER IMPLANT WAS IMMEDIATELY AVAILABLE AND THERE WAS NO SURGICAL DELAY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7388676 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K033716. One submission often covers many models, so check the product and lot details in each record.

• Z-2810-2015 · Jun 25, 2015 · Terminated
  Trident 10 degrees X3 Insert 36 mm ID Catalog #623-10-36I Hip implant component
• Z-0909-2010 · Feb 17, 2006 · Terminated
  Trident Acetabular Hip System Polyethylene Inserts, Stryker Orthopaedics, multiple sizes, Mahwah, NJ. Intended for use in cementless fixation fro use in total hip arthroplasty to