Ovation Tribute Hip Stem 101-0308Recalls & reported problems
Ortho Development Corporation · STD SIZE 8 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 00822409011018), received between Mar 26, 2018 and Jun 1, 2023 — 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.
Most reported problems
Device problems
- Adverse Event Without Identified Device or Use Problem3
Patient problems
- Hip Fracture1
- Inadequate Osseointegration1
- No Code Available1
Recent adverse event reports
The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.
InjuryJun 1, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
ON (B)(6) 2023, A PATIENT RECEIVED AN ARTIFICIAL HIP JOINT WITH A STEM AND BIPOLAR CUP. ON (B)(6) 2023, STEM SUBSIDENCE WAS OBSERVED. ON (B)(6) 2023, INNER HEAD PROLAPSE WAS OBSERVED. ON (B)(6) 2023, A REVISION WAS PERFORMED TO REPLACE THE STEM, THE OUTER CUP, AND INNER HEAD. THE SURGEON STATED THAT STEM SUBSIDENCE WAS DUE TO INTERNAL PLACEMENT AND SMALL SIZE. THE SUBSIDENCE LED TO DISLOCATION.
Patient problems: Inadequate Osseointegration
MAUDE report 17039813 ↗InjuryMay 14, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
A PATIENT UNDERWENT TOTAL HIP ARTHROPLASTY ON (B)(6) 2018. DURING REHABILITATION, A FEMORAL FRACTURE OCCURRED AND ON (B)(6) 2018, THE PATIENT WAS REVISED AND THE STEM REPLACED. THE SURGEON INDICATED THAT THE FRACTURE OCCURRED BECAUSE THE PATIENT APPLIED A STRONGER FORCE THAN USUAL DURING REHABILITATION. THIS REPORT WAS THE RESULT OF A POST MARKET SURVEY SO THE EVENT OCCURRED IN 2018 BUT WASN'T REPORTED UNTIL 2019.
Patient problems: Hip Fracture
MAUDE report 8609862 ↗InjuryMar 26, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
AN INTRAOPERATIVE FRACTURE OCCURRED DURING PLACEMENT OF A HIP STEM. THE SURGEON REPORTED A CRACK MIGHT HAVE BEEN CAUSED BY RASPING TOO HARD. WHEN THE IMPLANT WAS INSERTED, THE CRACK MIGHT HAVE CAUSED A DIAGONAL FRACTURE AROUND THE LESSER TROCHANTER. THE SURGEON PROVIDED ADDITIONAL SUPPORT WITH A PLATE AND CABLE AROUND THE FRACTURE LINE FOLLOWED BY CEMENT AROUND THE STEM.
Patient problems: No Code Available
MAUDE report 7372185 ↗
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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