Ovation Hip Stem 101-0006Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00822409010851), received between Sep 14, 2021 and Nov 20, 2025 — classified as 3 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 18, 2026.

Most reported problems

Recent adverse event reports

The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• InjuryNov 20, 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 BROACHING AND REMOVAL OF THE BROACH, A FRACTURE WAS DISCOVERED IN THE PROXIMAL FEMUR. THE FRACTURE WAS REINFORCED WITH A CABLE. AFTER CONFIRMING NO STEM SUBSIDENCE, THE OPERATION WAS COMPLETED. THE SURGEON COMMENTED THAT THE CORTICAL BONE OF THE PROXIMAL FEMUR APPEARED THIN, MAKING IT PRONE TO FRACTURE.

  Patient problems: Arthralgia

  MAUDE report 23610036 ↗
• InjuryOct 8, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  DURING SURGERY, X-RAYS SHOWED NO BONE FRACTURES. UPON INSERTING THE STEM, A FRACTURE OF THE GREATER TROCHANTER WAS CONFIRMED. THE STEM WAS REMOVED AND THE FRACTURE WAS WIRED. THE PATIENT'S FRAGILE BONE QUALITY WAS REFERENCED AS A CONTRIBUTING FACTOR.

  Patient problems: Arthralgia

  MAUDE report 20403161 ↗
• InjurySep 14, 2021Adverse 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. DURING POSTOPERATIVE X-RAY, A FEMORAL BONE FRACTURE WAS DISCOVERED UNDER THE LESSER TROCHANTER. THE PATIENT WAS REOPENED AND CABLE WAS USED TO REINFORCE THE BONE.

  Patient problems: Arthralgia

  MAUDE report 12471395 ↗

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-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
• 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