Quadra P femoral stems 01.12.143Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 07630040720557), received between Jul 12, 2024 and Sep 9, 2026 — classified as 2 injuries.

The most frequently reported specific device problem is “Device Appears to Trigger Rejection” (1 report).

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 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• InjurySep 9, 2026Device Appears to Trigger Rejection

  On (b)(6) 2022, the patient had primary surgery. On (b)(6) 2026, the patient came in due to infection and the pathogen is unknown. The surgeon performed a washout, revised the 28mm Biolox Head S to a same size head and revised the D 28/DMI HC liner to a same size liner. The surgery was completed successfully. Presently, on (b)(4) 2026, the patient came in due to signs of infection and the pathogen is unknown. The surgeon performed a washout, I&D, and revised all implants to antibiotic spacers. The surgery was completed successfully.

  Patient problems: Medical device site infection

  MAUDE report 50692295 ↗
• InjuryJul 12, 2024Failure to Osseointegrate; Failure to Osseointegrate

  AT ABOUT 11 MONTHS AFTER PRIMARY, THE PATIENT CAME IN REPORTING PAIN DUE TO A LOOSE STEM AND THE CAUSE IS UNKNOWN. THE SURGEON REVISED SUCCESSFULLY THE STEM, HEAD, AND LINER.

  Patient problems: Inadequate Osseointegration

  MAUDE report 19728255 ↗