Trident 509-02-64GRecalls & reported problems
Howmedica Osteonics Corp. · Hemispherical Shell · Class 2 · Implant
All models of Trident (160)
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- 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 07613327025194), received between Jul 18, 2019 and Jan 4, 2024 — classified as 4 injuries.
The most frequently reported specific device problem is “Insufficient Device Problem Information” (2 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 18, 2026.
Reports received per month
Most reported problems
Device problems
- Adverse Event Without Identified Device or Use Problem2
- Insufficient Device Problem Information2
- Loss of Osseointegration2
- Degraded1
Patient problems
- Inadequate Osseointegration2
- Injury2
- Pain2
- Bone Fracture(s)1
- Edema1
- Hip Fracture1
- Insufficient Information1
- Metal Related Pathology1
Recent adverse event reports
The 4 most recent of 4 reports, in the reporter's own words as published by the FDA.
InjuryJan 4, 2024Degraded; Loss of Osseointegration; Adverse Event Without Identified Device or Use Problem; Degraded; Loss of Osseointegration; Adverse Event Without Identified Device or Use Problem
TOTAL HIP REVISION. ACETABULAR CUP, MDM LINER AND MDM INSERT. UPDATE PER MEDICAL RECORDS RECEIVED: THE PATIENT WAS REVISED DUE TO LOOSENING OF THE ACETABULAR COMPONENT AND METALLOSIS.
Patient problems: Inadequate Osseointegration; Insufficient Information; Metal Related Pathology; Pain
MAUDE report 18444654 ↗InjuryNov 4, 2021Loss of Osseointegration; Loss of Osseointegration
AS REPORTED: "RIGHT REVISION TOTAL HIP ARTHROPLASTY. ACETABULAR COMPONENT, POSSIBLE FEMORAL COMPONENT. ALL ACETABULAR COMPONENTS WERE REMOVED. OBSERVATION: 4 BROKEN SCREWS REMOVED AND CUP WAS LOOSE. NO FURTHER INFORMATION AVAILABLE PER HOSPITAL."
Patient problems: Inadequate Osseointegration
MAUDE report 12750364 ↗InjurySep 5, 2019Adverse Event Without Identified Device or Use Problem; Insufficient Device Problem Information; Adverse Event Without Identified Device or Use Problem; Insufficient Device Problem Information
IT WAS REPORTED THAT THE PATIENT'S RIGHT HIP WAS REVISED DUE TO PELVIC DISCONTINUITY. INTRA-OPERATIVELY, A SMALL POCKET OF BLACK TISSUE WAS FOUND. THE SURGEON IS UNSURE OF WHERE THE BLACK TISSUE CAME FROM AS THE PATIENT DID NOT HAVE ANY COCR DEVICES SINCE A 2018 REVISION. THE 64 G TRIDENT HEMISPHERICAL SHELL WITH 5 SCREWS, 44G LINER, AND 44MM BIOLOX HEAD WITH +4 SLEEVE WERE REVISED (THERE ARE NO ALLEGATIONS AGAINST THE LINER OR HEAD). UPDATED ON 20-NOV-2019 BY SR BASED ON MEDICAL REVIEW OSTEOLYSIS IS EVIDENT AROUND THE TRIDENT SHELL AND LOOSE CUP WITH PELVIC SEPARATION IS REPORTED.
Patient problems: Bone Fracture(s); Hip Fracture; Injury; Osteolysis
MAUDE report 8965672 ↗InjuryJul 18, 2019Insufficient Device Problem Information; Insufficient Device Problem Information
IT WAS REPORTED THAT THE PATIENT'S LEFT HIP WAS REVISED. PATIENT PRESENTED WITH COMPLAINT OF PAIN (LOCATION AND SEVERITY OF PAIN UNKNOWN), SUBSEQUENT SCANS REVEALED THE PRESENCE OF PSEUDO TUMOR. INTRA-OPERATIVELY, NO BLACK TISSUE NOTED BUT THE PATIENT DID HAVE DISCOLORED FLUID. THE SHELL, MDM/ ADM LINER CONSTRUCT, AND BIOLOX CERAMIC HEAD WERE REVISED TO A COMPETITOR SHELL AND LINER WITH A STRYKER C-TAPER HEAD. THE STEM WAS NOT REVISED. THE EXPLANTS ARE AVAILABLE FOR RETURN.
Patient problems: Edema; Injury; Pain
MAUDE report 8803354 ↗
Other Prosthesis, hip, hemi-, femoral, metal/polymer, cemented or uncemented devices
- STAGEONE 431209Biomet Orthopedics, LLC · Prosthesis, hip, hemi-, femoral, metal/polymer, cemented or uncemented2 recalls0 reports
- SELF CENTERING 1035-45-000Depuy Orthopaedics, Inc. · Prosthesis, hip, hemi-, femoral, metal/polymer, cemented or uncemented84 reports
- LFIT 6260-9-036Howmedica Osteonics Corp. · Prosthesis, hip, hemi-, femoral, metal/polymer, cemented or uncemented80 reports
- ACTIS 101011060Depuy (Ireland) · Prosthesis, hip, hemi-, femoral, metal/polymer, cemented or uncemented66 reports
- RINGLOC BI-POLAR HIP SYSTEM 11-165228Biomet Orthopedics, LLC · Prosthesis, hip, hemi-, femoral, metal/polymer, cemented or uncemented1 recall1 death12 reports
- SELF CENTERING 1035-44-000Depuy Orthopaedics, Inc. · Prosthesis, hip, hemi-, femoral, metal/polymer, cemented or uncemented60 reports
- TANDEM 71324046Smith & Nephew, Inc. · Prosthesis, hip, hemi-, femoral, metal/polymer, cemented or uncemented1 recall9 reports
- TAPERLOC COMPLETE XR 123 MICRO FEMORAL 51-145170Biomet Orthopedics, LLC · Prosthesis, hip, hemi-, femoral, metal/polymer, cemented or uncemented59 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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