Trident 663-10-36FRecalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 07613327024913), received between Aug 26, 2019 and Sep 18, 2023 — classified as 4 injuries.

The most frequently reported specific device problem is “Device Dislodged or Dislocated” (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 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• InjurySep 18, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  I&D OF A LEFT HIP DUE TO INFECTION. HE CHANGED THE HEAD AND LINER.

  Patient problems: Unspecified Infection

  MAUDE report 17770460 ↗
• InjuryJan 10, 2022Fracture; Naturally Worn; Fracture; Naturally Worn

  AS REPORTED: "RIGHT SIDE HIP REVISION, ALL COMPONENTS EXPLANTED WERE STRYKER COMPONENTS. THE PATIENT WAS RE-IMPLANTED WITH ALL NEW REVISION COMPONENTS, AND THE CASE SHEET IS ATTACHED. THE ORIGINAL SURGERY WAS DONE IN 2011, THE PATIENT RECENTLY WAS REPORTING PAIN IN HIS RIGHT HIP, X-RAYS SHOWED ECCENTRIC WEAR ON THE POLYETHYLENE COMPONENT, AS WELL AS THE FEMORAL HEAD ON THE TRUNNION. THE PATIENT¿S COBALT CHROME LEVELS WERE ELEVATED, SO THE SURGEON DECIDED TO REVISE THE HIP COMPONENT. ADVERSE LOCAL TISSUE REACTIONS WERE MINIMAL, HOWEVER THE FEMORAL HEAD DID HAVE CORROSION AND FRETTING WAS NOTED ON THE TRUNNION. A PORTION OF THE SUPERIOR LIP OF THE POLYETHYLENE LINER WAS FRACTURED OFF. THE LOCKING MECHANISM WAS INTACT ON THE POLYETHYLENE/ACETABULAR COMPONENT JUNCTION, AND THE LINER WAS NOT DISASSOCIATED FROM THE ACETABULAR COMPONENT. ALL COMPONENTS WERE REMOVED." UPDATE: THE SHELL WAS REVISED BECAUSE THE SURGEON DIDN'T LIKE THE POSITION OF THE COMPONENT. THE DAMAGED PORTION OF THE LINER WAS THE PORTION THAT HAD THE LOT CODE ON IT THEREFORE IT WAS ILLEGIBLE.

  Patient problems: Foreign Body Reaction; Pain

  MAUDE report 13202873 ↗
• InjuryJun 22, 2020Device Dislodged or Dislocated; Device Dislodged or Dislocated

  PATIENTS HIP WAS REVISED FOR DISLOCATION. ALL IMPLANTS WERE REMOVED AND REPLACED WITH TRIDENT II TRITANIUM MULTIHOLE SHELL, MDM LINER, SECURFIT STEM AND 28MM BIOLOX HEAD. THIS IS THE SECOND REVISION. UPDATE 01/JUNE/2020 WG: LEFT HIP (PATIENT HAS HAD BILATERAL REVISIONS. THE SHELL AND SCREW (IMPLANTED (B)(6) 2016), LINER, HEAD, SLEEVE, STEM ((B)(6) 2020) WERE REVISED. UPDATE: "THE STEM WAS REVISED BECAUSE IT WAS UNDERSIZED AND HAD ALREADY HAD A MULTIPLE HEADS ON THE TRUNION. THE SURGEON WANTED TO PROPERLY SIZE THE FEMORAL STEM AND WANTED A FRESH TRUNION. THE SHELL WAS REVISED FOR INADEQUATE ANTEVERSION. THE DISLOCATION WAS OF THE FEMORAL HEAD OUT OF THE LINER. THE SURGEON DECLINED ANY FURTHER INFORMATION."

  Patient problems: Injury

  MAUDE report 10182227 ↗
• InjuryAug 26, 2019Device Dislodged or Dislocated; Device Dislodged or Dislocated

  THE DR. REPORTS PATIENT STATUS: POST LEFT TOTAL HIP REPLACEMENT THAT WAS REVISED ON (B)(6) 2017 CONTINUES TO HAVE RECURRENT DISLOCATIONS. THE DR DECIDED TO REVISE THE HIP TO AN MDM LINER AND INSERT AS WELL AS REPLACE THE HEAD. THE SURGERY WAS PERFORMED WITHOUT INCIDENT. NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: Injury

  MAUDE report 8930726 ↗