Ovation Hip Stem 101-0007Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 00822409010868), received between Oct 26, 2020 and May 10, 2022 — classified as 4 injuries.

4 other recalls cover devices cleared under the same FDA submission (K062775); they may or may not involve this specific model.

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.

Most reported problems

Recent adverse event reports

The 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• InjuryMay 10, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A TOTAL HIP ARTHROPLASTY WAS PERFORMED ON (B)(6) 2021. POSTOPERATIVELY, THE PATIENT WAS FOUND TO HAVE A FRACTURE OF THE GREATER TROCHANTER AND SINKING OF THE STEM. ON (B)(6) 2021, THE HIP WAS REVISED BY APPLYING CABLE TO THE BONE AND REPLACING THE STEM WITH A NEW ONE.

  Patient problems: Hip Fracture

  MAUDE report 14348217 ↗
• InjuryOct 30, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  AFTER BHA, POSTOPERATIVE IMAGING CONFIRMED A BONE FRACTURE. THE PATIENT WAS REOPENED AND THE BONE WAS REINFORCED WITH A PLATE AND CABLE. THE SURGEON SPECULATED THE FRACTURE MAY HAVE OCCURRED WHEN INSERTING THE STEM AND REPORTED AS UNFAMILIARITY WITH A SERIES OF BROACHING MOVEMENTS.

  Patient problems: Hip Fracture

  MAUDE report 12724995 ↗
• InjuryJul 20, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  DURING HIP ARTHROPLASTY, A FEMORAL BONE FRACTURE OCCURRED WHEN INSERTING THE HIP STEM. CABLE WAS USED TO REINFORCE THE BONE. THE SURGEON STATED THAT THE EVENT WAS NOT RELATED TO THIS DEVICE.

  Patient problems: Hip Fracture

  MAUDE report 12197106 ↗
• InjuryOct 26, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  DURING TOTAL HIP ARTHROPLASTY, INTRAOPERATIVE FRACTURES OCCURRED IN THE GREATER AND LESSER TROCHANTER WHEN INSERTING THE STEM. THE SURGEON REINFORCED THE FRACTURES WITH CABLE. THE SURGEON COMMENTED THAT THE PATIENT'S FRAGILE BONE QUALITY WAS THE CAUSE.

  Patient problems: Hip Fracture

  MAUDE report 10738120 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K062775. One submission often covers many models, so check the product and lot details in each record.

• Z-1673-2011 · Jan 11, 2011 · Terminated
  Ovation Hip Stem, REF 201-0104, Offset Stem Inserter Neutral, Non-Sterile, Ortho Development, Draper, Utah 84020. The Ovation Hip System is intended for use in total hip arthroplas
• Z-1671-2011 · Jan 11, 2011 · Terminated
  Ovation Hip Stem, REF 201-0102, Offset Stem Inserter RT, Non-Sterile, Ortho Development, Draper, Utah 84020. The Ovation Hip System is intended for use in total hip arthroplasty. T
• Z-1670-2011 · Jan 11, 2011 · Terminated
  Ovation Hip Stem, REF 201-0002, Hip Stem Inserter, Non-Sterile, Ortho Development, Draper, Utah 84020. The Ovation Hip System is intended for use in total hip arthroplasty. The hip
• Z-1672-2011 · Jan 11, 2011 · Terminated
  Ovation Hip Stem, REF 201-0103, Offset Stem Inserter LT, Non-Sterile, Ortho Development, Draper, Utah 84020. The Ovation Hip System is intended for use in total hip arthroplasty. T