Tritanium 500-03-50DRecalls & 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
- 5
- Deaths reported
- 0
- Injuries reported
- 5
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 07613327040005), received between Jun 25, 2018 and Oct 14, 2021 — classified as 5 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.
Most reported problems
Device problems
- Loss of Osseointegration2
- Failure to Osseointegrate1
- Malposition of Device1
- Osseointegration Problem1
Patient problems
- Injury4
- Inadequate Osseointegration3
- Pain3
- Inflammation1
- Reaction1
Recent adverse event reports
The 5 most recent of 5 reports, in the reporter's own words as published by the FDA.
InjuryOct 14, 2021Loss of Osseointegration; Loss of Osseointegration
REVISION HIP FOR ASEPTIC LOOSENING OF ACETABULAR COMPONENT.
Patient problems: Inadequate Osseointegration
MAUDE report 12634345 ↗InjuryJun 30, 2020Loss of Osseointegration; Loss of Osseointegration
IT WAS REPORTED THAT THE PATIENT'S RIGHT HIP WAS REVISED DUE TO TRUNNIONOSIS AND SHELL LOOSENING. INTRA-OPERATIVELY, BLACK MATERIAL INSIDE THE FEMORAL HEAD AND PSEUDOTUMOR WERE NOTED. THE PATIENT'S SHELL, LINER, AND FEMORAL HEAD WERE REVISED TO A NEW STRYKER SHELL, LINER, AND CERAMIC HEAD WITH SLEEVE. REP CONFIRMED THERE ARE NO ALLEGATIONS AGAINST THE REVISED LINER. REP ALSO CONFIRMED THE FEMORAL HEAD WILL BE RETURNED. THE SURGEON IS REQUESTING INVESTIGATION RESULTS FOR THE FEMORAL HEAD.
Patient problems: Inflammation; Injury; Pain; Reaction
MAUDE report 10210688 ↗InjuryFeb 24, 2020Failure to Osseointegrate; Failure to Osseointegrate
REVISION TOTAL HIP FOR ASEPTIC LOOSENING OF THE ACETABULAR COMPONENT. PATIENT COMPLAINED OF PAIN.
Patient problems: Inadequate Osseointegration; Injury; Pain
MAUDE report 9745976 ↗InjuryJan 23, 2019Osseointegration Problem; Osseointegration Problem
AS REPORTED: "LEFT HIP [REVISION] - THIGH PAIN, LOOSE PROSTHESIS PROBABLE". A 36 0° X3 INSERT, 50MM TITANIUM SHELL, 36 +5 BIOLOX V40 HEAD, AND ACCOLADE II #3 132° WERE REVISED TO COMPETITOR DEVICES.
Patient problems: Inadequate Osseointegration; Injury; Pain
MAUDE report 8271296 ↗InjuryJun 25, 2018Malposition of Device; Malposition of Device
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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