Ovation Hip Stem 101-0005Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00822409010844), received between Apr 18, 2023 and Oct 18, 2023 — classified as 2 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 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• InjuryOct 18, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  DURING HIP ARTHROPLASTY, AN INTRAOPERATIVE FRACTURE WAS OBSERVED IN THE INFERIOR END OF THE LESSER TROCHANTER THAT WAS REINFORCED WITH CABLING.

  Patient problems: Arthralgia

  MAUDE report 17961168 ↗
• InjuryApr 18, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  WHILE BROACHING DURING TOTAL HIP ARTHROPLASTY, A LONGITUDINAL BONE FRACTURE OCCURRED THAT THE SURGEON REINFORCED WITH CABLE AND COMPLETED THE OPERATION WITHOUT PROBLEMS.

  Patient problems: Arthralgia

  MAUDE report 16765567 ↗

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-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-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-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