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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 · 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

Other Prosthesis, hip, semi-constrained, metal/polymer, cemented devices

All Prosthesis, hip, semi-constrained, metal/polymer, cemented devices →

Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.