Trident 65C-3254Recalls & reported problems
Howmedica Osteonics Corp. · Polyethylene Acetabular Cup · Class 2 · Implant
All models of Trident (160)
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 1
- Deaths reported
- 0
- Injuries reported
- 1
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 07613327024234), received between Apr 1, 2020 and Apr 1, 2020 — classified as 1 injury.
The most frequently reported specific device problem is “Insufficient Device Problem Information” (1 report).
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
Device problems
- Insufficient Device Problem Information1
Patient problems
- Inflammation1
- Injury1
- Reaction1
- Unspecified Infection1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
InjuryApr 1, 2020Insufficient Device Problem Information; Insufficient Device Problem Information
THIS PI IS FOR REVISION 1 ON 2015. IT WAS REPORTED THROUGH A MEDWATCH REPORT (MW5092862) "ON 2005, HE UNDERWENT A COMPLEX LEFT HIP TOTAL HIP ARTHROPLASTY WITH REMOVAL OF EXISTING ACETABULAR HARDWARE, WHICH HAD BEEN PLACED FOR A SEVERE ACETABULAR FRACTURE POST MOTOR VEHICLE ACCIDENT IN 2004. HIS ACETABULAR FRACTURE WAS COMPLICATED BY RADIATION-RELATED WOUND NECROSIS AND ENTEROCOCCUS DEEP INFECTION AND ALSO BY PERSISTENT PERONEAL NERVE AND HIP ABDUCTOR PALSIES. DUE TO HISTORY OF INFECTION, THE DECISION WAS MADE TO COMPLETELY REMOVE THE ACETABULAR FIXATION HARDWARE AND TO USE CEMENTED COMPONENTS WITH ANTIBIOTIC LOADED CEMENT. THE IMPLANT USED WAS A HIP PROSTHESIS, CEMENTED 12/14 NECK TAPER, STANDARD OFFSET NECK, 125MM STEM LENGTH SIZE 12 COCR MO, ; DISTAL CENTRALIZER 9MM OO ASSEMBLE W/ BONE CEMENT PMMA STERILE, HIP SYSTEM FEMORAL HEAD 12/14 TAPER 32MM DIA +0 MM NECK LENGTH COCR-MO, HOWMEDICA/OSTEONICS 65C-3254 TRIDENT POLYETHYLENE ACETABULAR CUP, HOWMEDICA X-CHANGE BIO MESH LARGE; BONESOURCE BVF, SIMPLEX P WITH TOBRAMYCIN ANTIBIOTIC BONE CEMENT TIMES 2 . THIS WAS A COMPLEX PRIMARY TOTAL HIP ARTHROPLASTY WITH A TRANSTROCHANTERIC APPROACH FOR SLOOF ACETABULAR RECONSTRUCTION AND THE ALL-
Patient problems: Inflammation; Injury; Reaction; Unspecified Infection
MAUDE report 9913499 ↗
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 and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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