Tritanium 500-03-58FRecalls & 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 07613327040050), received between Aug 14, 2017 and Jun 3, 2025 — classified as 5 injuries.
The most frequently reported specific device problem is “Loss of Osseointegration” (4 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 Osseointegration4
- Device Dislodged or Dislocated1
Patient problems
- Inadequate Osseointegration3
- Pain2
- Injury1
- Joint Dislocation1
Recent adverse event reports
The 5 most recent of 5 reports, in the reporter's own words as published by the FDA.
InjuryJun 3, 2025Loss of Osseointegration; Loss of Osseointegration
THE SITE NOTIFIED STRYKER ON (B)(6) 2025 THAT DR. ASSESSED THIS SUBJECT'S CLINIC NOTES AND CONFIRMED THERE WAS A LOOSENING OF THE CUP. PERSISTENT NON-UNION FRACTURE (B)(6) 2017 OF THE POSTERIOR COLUMN WITH RADIOLUCENCY OF THE ACETABULUM.
Patient problems: Inadequate Osseointegration
MAUDE report 22131166 ↗InjuryApr 29, 2024Loss of Osseointegration; Loss of Osseointegration
IT WAS REPORTED THE PATIENT HAD A HIP CUP REVISION DUE TO ASEPTIC LOOSENING.
Patient problems: Inadequate Osseointegration
MAUDE report 19202138 ↗InjuryFeb 8, 2023Device Dislodged or Dislocated; Device Dislodged or Dislocated
IT WAS REPORTED THAT THE PATIENT'S RIGHT HIP WAS REVISED. AS REPORTED: "REVISION OF RIGHT TOTAL HIP. PATIENT IS DISLOCATING." A SHELL, HEAD, AND LINER WERE REVISED.
Patient problems: Joint Dislocation
MAUDE report 16330556 ↗InjuryJan 2, 2019Loss of Osseointegration; Loss of Osseointegration
AS REPORTED: "PT REPORTED LEFT POSTERIOR HIP PAIN. ONSET OF PAIN WAS GRADUAL AND THEN WORSENED WITH PROLONGED ACTIVITY AND WEIGHT BEARING. X-RAYS REVEALED PROGRESSIVE LUCENCY. BONE SCAN REVEALED INCREASED UPTAKE AROUND THE ACETABULUM. ON (B)(6) 2018 SUBJECT RETURNED TO CLINIC FOR A FOLLOW-UP ASSESSMENT WITH PI. SUBJECT REPORTED HE IS 6-WEEKS POST-OP CONTRALATERAL (R) THA AND AFTER COMPLETING PHYSICAL THERAPY FOR CONTRALATERAL THA, SUBJECT REPORTS STUDY HIP (L) PAIN HAS MOSTLY SUBSIDED. PI WILL SEE SUBJECT FOR FOLLOW-UP (L) THA ASSESSMENT ON (B)(6) 2019. PI DEEMED THIS ADVERSE EVENT AS 'UNCERTAIN' REGARDING STUDY DEVICE RELATIONSHIP".
Patient problems: Pain
MAUDE report 8210389 ↗InjuryAug 14, 2017Loss of Osseointegration; Loss of Osseointegration
IT WAS REPORTED THAT A PATIENT'S RIGHT HIP WAS REVISED DUE TO PAIN AND A LOOSE CUP. EXPLANTED DEVICES WERE TRITANIUM CUP, LINER, HEAD.
Patient problems: Inadequate Osseointegration; Injury; Pain
MAUDE report 6793427 ↗
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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