Quadra S femoral stems 01.12.004Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 07630030801853), received between Jun 15, 2018 and May 6, 2021 — classified as 4 injuries.

The most frequently reported specific device problem is “Break” (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 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• InjuryMay 6, 2021Break; Break

  THE PATIENT CAME IN REPORTING PAIN. THE SURGEON OBSERVED THAT THE NECK OF THE STEM HAD BROKEN. THE SURGEON REVISED THE MEDACTA STEM, AND COMPETITOR HEAD, CUP, AND LINER TO COMPETITOR COMPONENTS 12 YEARS AND 4 MONTHS AFTER PRIMARY. THE SURGERY WAS COMPLETED SUCCESSFULLY. THE PRIMARY SURGERY IN 2008 WAS A MEDACTA STEM COUPLED WITH A COMPETITOR'S METAL ON METAL SHELL AND HEAD. THE PATIENT DID NOT UNDERGO PREVIOUS REVISION SURGERY.

  Patient problems: Pain

  MAUDE report 11782830 ↗
• InjuryFeb 16, 2021Loose or Intermittent Connection

  REVISION SURGERY 11 YEARS AND 8 MONTHS AFTER THE PRIMARY SURGERY FOR PAIN DUE TO A LOOSE STEM. THE CAUSE OF THE LOOSE STEM IS UNKNOWN. THE SURGEON REVISED THE STEM, HEAD, AND LINER AND THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: Inadequate Osseointegration

  MAUDE report 11331085 ↗
• InjuryApr 12, 2019Appropriate Device Problem Term/Code Not Available

  REVISION SURGERY 10 MONTHS AFTER THE PRIMARY SURGERY DUE TO EXTENSIVE THIGH PAIN. THE X-RAY EXAMINATION SHOWED MOBILIZED STEM. THE STEM HAS BEEN REMOVED AND WAGNER STYLE STEM HAS BEEN IMPLANTED WITH DAC (ANTIBIOTIC GEL), ANTIBIOTIC THERAPY. NO INFECTION PRESENT.

  Patient problems: Inadequate Osseointegration

  MAUDE report 8508150 ↗
• InjuryJun 15, 2018Fracture

  REVISION SURGERY DUE TO FEMORAL FRACTURE 10 DAYS AFTER PRIMARY. DURING THE REVISION SURGERY, SURGEON EASILY EXPLANTED THE FEMORAL STEM AND FIXED THE FEMORAL FRACTURE USING 4 BONE CERCLAGES AND IMPLANTED A WAGNER TYPE STEM. SURGEON LEFT THE CUP (MPACT DM) IN PLACE AND CHANGED FEMORAL HEAD AND DM LINER WITH NEW ONES.

  Patient problems: Bone Fracture(s)

  MAUDE report 7605410 ↗

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