Tritanium 500-03-48CRecalls & reported problems
Howmedica Osteonics Corp. · Hemispherical Solid Back Shell · Class 2 · Implant
All models of Tritanium (18)
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 3
- Deaths reported
- 0
- Injuries reported
- 3
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 07613327039993), received between Mar 15, 2021 and Jun 26, 2025 — classified as 3 injuries.
The most frequently reported specific device problem is “Loss of Osseointegration” (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 16, 2026.
Reports received per month
Most reported problems
Device problems
- Loss of Osseointegration2
- Migration1
Patient problems
- Inadequate Osseointegration2
- Pain2
- Osteolysis1
Recent adverse event reports
The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.
InjuryJun 26, 2025Loss of Osseointegration; Loss of Osseointegration
THE PRIMARY SURGERY WAS PERFORMED ON (B)(6) 2020. ON (B)(6), 2025, THE REVISION SURGERY WAS PERFORMED BECAUSE OSTEOLYSIS WAS OBSERVED APPROXIMATELY ONE YEAR AFTER THE INITIAL SURGERY, AND THE PATIENT REPORTED PAIN DUE TO LOOSENING OF THE CUP. THE SURGEON HAS USED HA EXTENSIVELY IN THE PAST BUT USED THIS PRODUCT BECAUSE THE PATIENT IN THIS CASE WAS ALLERGIC TO SILVER.
Patient problems: Inadequate Osseointegration; Osteolysis; Pain
MAUDE report 22334907 ↗InjuryOct 23, 2023Migration; Migration
ON (B)(6), 2017, PRIMARY THA SURGERY WAS PERFORMED AND THE TRITANIUM CUP WAS IMPLANTED IN THE LEFT HIP OF THE FEMALE PATIENT. ON (B)(6), 2023, CENTRAL MIGRATION WAS CONFIRMED. THE CUP WAS ABOUT TO GO THROUGH THE INNER PLATE OF THE HIP JOINT AND THE PATIENT COMPLAINED OF PAIN.
Patient problems: Pain
MAUDE report 17983422 ↗InjuryMar 15, 2021Loss of Osseointegration; Loss of Osseointegration
IT WAS REPORTED BY PATIENT'S COUNSEL THAT ALLEGEDLY THE PATIENT WAS IMPLANTED WITH A TRITANIUM ACETABULAR CUP ON (B)(6) 2016 AND WAS REVISED ON (B)(6) 2020 DUE TO ALLEGED CUP LOOSENING.
Patient problems: Inadequate Osseointegration
MAUDE report 11490247 ↗
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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