Trident 663-00-32DRecalls & reported problems
Howmedica Osteonics Corp. · 0 Degree Eccentric Insert · Class 2 · Implant
- Adverse event reports
- 4
- Deaths reported
- 0
- Injuries reported
- 4
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 07613327024630), received between Jan 22, 2019 and Aug 25, 2022 — classified as 4 injuries.
The most frequently reported specific device problem is “Unstable” (3 reports).
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. How this data works · Data updated Oct 13, 2026.
Most reported problems
Device problems
- Unstable3
- Insufficient Device Problem Information1
Patient problems
- Joint Laxity3
- Joint Dislocation2
- Injury1
- Metal Related Pathology1
- Unspecified Infection1
Recent adverse event reports
The 4 most recent of 4 reports, in the reporter's own words as published by the FDA.
InjuryAug 25, 2022Unstable; Unstable
IT WAS REPORTED THAT THE PATIENT'S RIGHT HIP WAS REVISED DUE TO INSTABILITY. A SHELL, 6 SCREWS, HEAD AND LINER WERE REVISED TO ANOTHER SHELL, LINER, SCREWS, AND HEAD.
Patient problems: Joint Laxity
MAUDE report 15294979 ↗InjuryJan 14, 2022Unstable; Unstable
THIS PI IS FOR THE RECURRENT DISLOCATIONS ENDING IN (B)(6) 2021. IT WAS REPORTED THROUGH THE FILING OF A LAWSUIT THAT ALLEGEDLY THE PATIENT WAS IMPLANTED WITH AN LFIT ANATOMIC COCR V40 FEMORAL HEAD ON HER RIGHT HIP ON OR ABOUT (B)(6) 2012 AND WAS REVISED ON (B)(6) 2021. IT IS FURTHER ALLEGED THAT SHE SUFFERED INJURIES AS A RESULT OF IMPLANTATION AND EXPLANTATION OF THE DEVICE(S) AT ISSUE, DEVICE RECALL AND EXCESSIVE LEVELS OF CHROMIUM AND COBALT IN HER BLOOD. MEDICAL RECORDS INDICATED THAT THE PATIENT HAD RECURRENT DISLOCATIONS, WITH THE FINAL DISLOCATION OCCURRING IN (B)(6) 2021.
Patient problems: Joint Dislocation; Joint Laxity
MAUDE report 13257064 ↗InjuryJan 12, 2022Unstable; Unstable
THIS PI IS FOR THE REVISION EVENT THAT TOOK PLACE ON (B)(6) 2021. IT WAS REPORTED THROUGH THE FILING OF A LAWSUIT THAT ALLEGEDLY THE PATIENT WAS IMPLANTED WITH AN LFIT ANATOMIC COCR V40 FEMORAL HEAD ON HER RIGHT HIP ON OR ABOUT (B)(6) 2012 AND WAS REVISED ON (B)(6) 2021. IT IS FURTHER ALLEGED THAT SHE SUFFERED INJURIES AS A RESULT OF IMPLANTATION AND EXPLANTATION OF THE DEVICE(S) AT ISSUE, DEVICE RECALL AND EXCESSIVE LEVELS OF CHROMIUM AND COBALT IN HER BLOOD. MEDICAL RECORDS INDICATED THAT THE PATIENT HAD RECURRENT DISLOCATIONS, WITH THE FINAL DISLOCATION OCCURRING IN (B)(6) 2021.
Patient problems: Joint Dislocation; Joint Laxity; Metal Related Pathology
MAUDE report 13240095 ↗InjuryJan 22, 2019Insufficient Device Problem Information; Insufficient Device Problem Information
IT WAS REPORTED THAT A STAGE 1 REVISION WAS PERFORMED ON PATIENT'S LEFT HIP DUE TO INFECTION (INFECTION REPORTED BY SURGEON, UNKNOWN IF CLINICALLY CONFIRMED OR IDENTIFIED). A SHELL AND SCREW (IMPLANTED (B)(6) 2015), LINER, HEAD, AND RESTORATION MODULAR STEM CONSTRUCT (IMPLANTED (B)(6) 2018) WERE REMOVED AND A CEMENT SPACER PLACED.
Patient problems: Injury; Unspecified Infection
MAUDE report 8267612 ↗
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 · TerminatedTrident 10 degrees X3 Insert 36 mm ID Catalog #623-10-36I Hip implant component
- Z-0909-2010 · Feb 17, 2006 · TerminatedTrident Acetabular Hip System Polyethylene Inserts, Stryker Orthopaedics, multiple sizes, Mahwah, NJ. Intended for use in cementless fixation fro use in total hip arthroplasty to
Other Prosthesis, hip, semi-constrained, metal/polymer, cemented devices
- NA 1365-51-000Depuy (Ireland) · Prosthesis, hip, semi-constrained, metal/polymer, cemented753 reports
- NA 1365-50-000Depuy (Ireland) · Prosthesis, hip, semi-constrained, metal/polymer, cemented412 reports
- ARTICUL/EZE 1365-21-000Depuy (Ireland) · Prosthesis, hip, semi-constrained, metal/polymer, cemented1 recall280 reports
- ARTICUL/EZE 1365-11-000Depuy (Ireland) · Prosthesis, hip, semi-constrained, metal/polymer, cemented1 death262 reports
- LFIT 6260-9-236Howmedica Osteonics Corp. · Prosthesis, hip, semi-constrained, metal/polymer, cemented256 reports
- PINNACLE GRIPTION 1217-32-052Depuy Orthopaedics, Inc. · Prosthesis, hip, semi-constrained, metal/polymer, cemented2 deaths239 reports
- ELEOS™ 25002111EOnkos Surgical, Inc. · Prosthesis, hip, semi-constrained, metal/polymer, cemented3 deaths230 reports
- Novation 130-36-52Exactech, Inc. · Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Cemented2 recalls124 reports
Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.