Quadra S femoral stems 01.12.003Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 07630030801846), received between Sep 26, 2017 and Feb 25, 2021 — classified as 2 injuries.

The most frequently reported specific device problem is “Loose or Intermittent Connection” (1 report).

1 other recall cover devices cleared under the same FDA submission (K072857); 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 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• InjuryFeb 25, 2021Loosening of Implant Not Related to Bone-Ingrowth

  REVISION SURGERY PERFORMED ON (B)(6) 2021 DUE TO STEM LOOSENING. PRIMARY DETAILS ARE UNKNOWN. THE SURGEON REVISED THE STEM AND HEAD. THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: Inadequate Osseointegration

  MAUDE report 11377717 ↗
• InjurySep 26, 2017Loose or Intermittent Connection

  THE PATIENT CAME IN COMPLAINING OF PAIN. THE SURGEON DETERMINED THE STEM WAS LOOSE. THE CAUSE OF THE LOOSENING IS UNKNOWN. THE SURGEON REVISED THE STEAM, HEAD AND LINER. THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: Joint Disorder; Pain

  MAUDE report 6893678 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K072857. One submission often covers many models, so check the product and lot details in each record.

• Z-0791-2013 · Dec 17, 2012 · Terminated
  Medacta Quadra Trial Broach size 0 part # 01.10.10.045, for use with the Medacta Total Hip Prosthesis System. Product Usage - used to broach the intramedullary canal of the femur