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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

All PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED devices →

Sources and updates

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