Ovation Hip Stem 101-0003Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00822409010820), received between Jul 18, 2025 and Jul 18, 2025 — classified as 1 injury.

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 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

• InjuryJul 18, 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. POSTOPERATIVELY, A PERI-STEM FRACTURE OCCURRED POSSIBLY DURING REHABILITATION. ON (B)(6) 2025, A REVISION SURGERY WAS PERFORMED TO ADD A PLATE AND WIRE.

  Patient problems: Arthralgia

  MAUDE report 22546305 ↗

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-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-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-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