TRIDENT II 709-04-46CRecalls & reported problems
Howmedica Osteonics Corp. · Trident II Tritanium Multihole Acetabular Shell 46C · Class 2 · Implant
All models of TRIDENT II (42)
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 2
- Deaths reported
- 0
- Injuries reported
- 2
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 07613327344035), received between Nov 15, 2023 and Mar 3, 2025 — classified as 2 injuries.
The most frequently reported specific device problem is “Degraded” (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 18, 2026.
Reports received per month
Most reported problems
Device problems
- Degraded1
- Malposition of Device1
- Patient-Device Incompatibility1
Patient problems
- Foreign Body Reaction1
- Hypersensitivity/Allergic reaction1
- Joint Dislocation1
- Metal Related Pathology1
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
InjuryMar 3, 2025Degraded; Patient-Device Incompatibility; Degraded; Patient-Device Incompatibility
NO NEW INFORMATION.
Patient problems: Foreign Body Reaction; Hypersensitivity/Allergic reaction; Metal Related Pathology
MAUDE report 21511249 ↗InjuryNov 15, 2023Malposition of Device; Malposition of Device
THA WAS PERFORMED FOR LEFT HIP OF THE FEMALE PATIENT ON (B)(6) 2023. THE REVISION SURGERY WAS PERFORMED ON (B)(6) 2023 BECAUSE OF FREQUENT DISLOCATIONS. ACCIDENTLY, THE EXETER V40 STEM AND THE DELTA V40 CERAMIC HEAD WERE IMPLANTED IN COMBINATION IN THE REVISION SURGERY. THE SURGEON DECIDES THAT THE STEM AND THE HEAD ARE LEFT AS THEY ARE IN THE PATIENT'S HIP AND WILL KEEP MONITORING. THE ISSUE WAS THAT THE CUP WITH THE LINER WAS COME OFF (DISLOCATED) WHILE THE HEAD WAS FIXED TO THE STEM. BECAUSE THE DOCTOR TOOK INTO CONSIDERATION THE FACT THAT THE CUP WAS INSTALLED AT AN INCORRECT ANGLE AND THE ANTEVERSION ANGLE OF THE STEM WAS TOO SHARP, THE ENTIRE IMPLANT PRODUCTS, INCLUDING NOT ONLY THE CUP AND LINER BUT ALSO THE HEAD AND STEM, WERE REPLACED. THIS RECORD WAS OPENED FOR REVISION SURGERY BY FREQUENT DISLOCATIONS AND INCORRECT COMBINATION IMPLANTATION IN THE REVISION SURGERY WAS OPENED IN ANOTHER RECORD.
Patient problems: Joint Dislocation
MAUDE report 18144498 ↗
Other Prosthesis, hip, semi-constrained, metal/ceramic/polymer, cemented or non-porous, uncemented devices
- BIOLOX DELTA 1365-32-310Depuy Orthopaedics, Inc. · Prosthesis, hip, semi-constrained, metal/ceramic/polymer, cemented or non-porous, uncemented551 reports
- PINNACLE ALTRX 1221-36-052Depuy Orthopaedics, Inc. · Prosthesis, hip, semi-constrained, metal/ceramic/polymer, cemented or non-porous, uncemented481 reports
- BIOLOX DELTA 1365-32-320Depuy Orthopaedics, Inc. · Prosthesis, hip, semi-constrained, metal/ceramic/polymer, cemented or non-porous, uncemented1 death314 reports
- BIOLOX DELTA 1365-36-720Depuy Orthopaedics, Inc. · Prosthesis, hip, semi-constrained, metal/ceramic/polymer, cemented or non-porous, uncemented1 death189 reports
- DJO SURGICAL 400-03-362Encore Medical, L.P. · Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented187 reports
- Anthology 71365705Smith & Nephew, Inc. · Prosthesis, hip, semi-constrained, metal/ceramic/polymer, cemented or non-porous, uncemented176 reports
- BIOLOX DELTA 1365-40-710Depuy Orthopaedics, Inc. · Prosthesis, hip, semi-constrained, metal/ceramic/polymer, cemented or non-porous, uncemented170 reports
- PINNACLE GRIPTION 1217-32-054Depuy Orthopaedics, Inc. · Prosthesis, hip, semi-constrained, metal/ceramic/polymer, cemented or non-porous, uncemented169 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 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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