Ovation Tribute Hip Stem 101-0307Recalls & reported problems
Ortho Development Corporation · STD SIZE 7 Stem Plasma Spray · Class 2 · Implant
Data updated Oct 18, 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 00822409011001), received between Jan 5, 2021 and Dec 22, 2025 — classified as 3 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.
Reports received per month
Most reported problems
Device problems
- Adverse Event Without Identified Device or Use Problem3
Patient problems
- Bone Fracture(s)3
Recent adverse event reports
The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.
InjuryDec 22, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
ON (B)(6) 2025, A PATIENT RECEIVED TOTAL HIP ARTHROPLASTY. DURING STEM INSERTION, A FRACTURE OCCURRED. AN ATTEMPT WAS MADE TO REINFORCE THE FRACTURE WITH A CABLE BUT THE REPORTER STATED IT WAS NOT POSSIBLE. THE STEM WAS INSERTED AND THE OPERATION COMPLETED. THE SURGEON COMMENTED THAT THE PATIENT'S BONE QUALITY WAS POOR AND THE SKIN INCISION WAS TOO SMALL POTENTIALLY CAUSING A TECHNICAL ERROR.
Patient problems: Bone Fracture(s)
MAUDE report 23871194 ↗InjuryFeb 23, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
ON (B)(6) 2020, A PATIENT RECEIVED TOTAL HIP ARTHROPLASTY. ON (B)(6) 2020, IT WAS REVISED AND THE STEM REMOVED DUE TO A BONE FRACTURE THAT HAD DEVELOPED.
Patient problems: Bone Fracture(s)
MAUDE report 11366615 ↗InjuryJan 5, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
ON (B)(6) 2019, A PATIENT RECEIVED TOTAL HIP ARTHROPLASTY ON BOTH LEGS WITH NO FRACTURES CONFIRMED DURING OR IMMEDIATELY AFTER THE OPERATION AND NO PROBLEMS. ON (B)(6) 2019, ONE SIDE WAS REVISED DUE TO SINKING AND A BONE FRACTURE. THE STEM WAS REMOVED AND CABLE WAS APPLIED TO REINFORCE THE BONE. ANOTHER COMPANY'S STEM WAS IMPLANTED. THE SURGEON REPORTED THE PATIENT'S WEAK BONE QUALITY DUE TO RHEUMATISM WAS THE POSSIBLE CAUSE.
Patient problems: Bone Fracture(s)
MAUDE report 11120296 ↗
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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