Ovation Tribute Hip Stem 101-0306Recalls & reported problems
Ortho Development Corporation · STD SIZE 6 Stem Plasma Spray · Class 2 · Implant
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 2
- Deaths reported
- 0
- Injuries reported
- 2
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00822409010998), received between Jun 16, 2020 and Jan 4, 2021 — classified as 2 injuries.
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.
Most reported problems
Device problems
- Adverse Event Without Identified Device or Use Problem2
Patient problems
- Bone Fracture(s)1
- Hip Fracture1
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
InjuryJan 4, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
A PATIENT PRESENTING WITH A PERI-STEM FRACTURE RECEIVED TOTAL HIP ARTHROPLASTY ON (B)(6) 2019 WITH NO FRACTURES CONFIRMED DURING OR IMMEDIATELY AFTER THE OPERATION AND NO PROBLEMS. ON (B)(6) 2019, STEM SINKING AND AN OBLIQUE FRACTURE WERE DETECTED. ON (B)(6) 2019, A REVISION SURGERY WAS PERFORMED AND THE STEM AND HEAD WERE REMOVED. THE FRACTURE WAS REINFORCED WITH CABLE AND ANOTHER COMPANY'S COMPONENTS WERE INSERTED. THE PATIENT WAS REPORTED TO HAVE FRAGILE BONE QUALITY AND RHEUMATOID ARTHRITIS.
Patient problems: Bone Fracture(s)
MAUDE report 11114494 ↗InjuryJun 16, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
ORIGINAL HIP SURGERY WAS PERFORMED ON (B)(6) 2019. AFTER SURGERY, THE PATIENT REPORTED FEELING PAIN WHEN CLIMBING STAIRS. ON (B)(6) 2018, THE SURGEON RE-OPERATED AND PLACED WIRING DUE TO A PERI-STEM FRACTURE.
Patient problems: Hip Fracture
MAUDE report 10158508 ↗
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 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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