Trident II 7030-6520Recalls & reported problems
Howmedica Osteonics Corp. · 6.5MM LOW PROFILE HEX SCREW 20MM · Class 2 · Implant
All models of TRIDENT II (42)
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 5
- Deaths reported
- 0
- Injuries reported
- 4
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 07613327345094), received between Sep 13, 2021 and Nov 25, 2025 — classified as 4 injuries, 1 malfunction.
The most frequently reported specific device problem is “Fracture” (3 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.
Reports received per month
Most reported problems
Device problems
- Fracture3
- Material Fragmentation3
- Adverse Event Without Identified Device or Use Problem1
- Osseointegration Problem1
- Unstable1
Patient problems
- Joint Dislocation2
- Foreign Body In Patient1
- Hematoma1
- Inadequate Osseointegration1
- Insufficient Information1
- Joint Laxity1
- No Clinical Signs, Symptoms or Conditions1
Recent adverse event reports
The 5 most recent of 5 reports, in the reporter's own words as published by the FDA.
InjuryNov 25, 2025Fracture; Material Fragmentation; Fracture; Material Fragmentation
NO NEW INFORMATION.
Patient problems: Insufficient Information; Joint Dislocation
MAUDE report 23642898 ↗InjuryAug 12, 2025Fracture; Material Fragmentation; Osseointegration Problem; Fracture; Material Fragmentation; Osseointegration Problem
NO NEW INFORMATION.
Patient problems: Inadequate Osseointegration; Joint Dislocation
MAUDE report 22780531 ↗MalfunctionAug 28, 2023Fracture; Material Fragmentation; Fracture; Material Fragmentation
THE SCREW TIP WAS BROKEN OFF INSIDE THE BODY DURING SCREW INSERTION AND REMAINED INSIDE THE BODY.
Patient problems: Foreign Body In Patient; No Clinical Signs, Symptoms or Conditions
MAUDE report 17633911 ↗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 15294930 ↗InjurySep 13, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT THE PATIENT'S LEFT HIP WAS REVISED. TWO DAYS POST OP, A LARGE HEMATOMA HAD FORMED AND SUSPECTED TO BE OVER A NERVE AS THE PATIENT WAS EXPERIENCING FOOT WEAKNESS. TWO 20MM SCREWS, TWO 15MM SCREWS, AN MDM METAL LINER, ADM/ MDM POLY INSERT, AND 28 +4 HEAD WERE REVISED. THE 20MM SCREWS WERE REPLACED WITH TWO ADDITIONAL 15MM SCREWS, AND THE MDM METAL LINER, ADM/ MDM POLY INSERT, AND FEMORAL HEAD WERE RE-IMPLANTED. REP CONFIRMED THERE ARE NO ALLEGATIONS AGAINST THE REVISED AND RE-IMPLANTED METAL LINER, POLY INSERT, OR FEMORAL HEAD. REP PROVIDED THE PRIMARY USAGE SHEET AND CONFIRMED THAT NO FURTHER INFORMATION WILL BE RELEASED BY THE HOSPITAL OR SURGEON.
Patient problems: Hematoma
MAUDE report 12460651 ↗
Other PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED devices
- PINNACLE 1217-25-500Depuy Orthopaedics, Inc. · PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED735 reports
- NA 1365-52-000Depuy (Ireland) · PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED683 reports
- APEX 1246-03-000Depuy (Ireland) · PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED3 deaths613 reports
- PINNACLE 1217-20-500Depuy Orthopaedics, Inc. · PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED2 deaths590 reports
- PINNACLE 1217-30-500Depuy Orthopaedics, Inc. · PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED1 death484 reports
- NA 1365-53-000Depuy (Ireland) · PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED404 reports
- PINNACLE ALTRX 1221-36-054Depuy Orthopaedics, Inc. · PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED388 reports
- PINNACLE ALTRX 1221-32-050Depuy Orthopaedics, Inc. · PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED386 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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