Quadra H femoral stems 01.12.25SNRecalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 07630030802652), received between Jan 19, 2018 and Oct 25, 2018 — classified as 3 injuries.

The most frequently reported specific device problem is “Fracture” (2 reports).

1 other recall cover devices cleared under the same FDA submission (K093944, K250450); 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 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• InjuryOct 25, 2018Unintended Movement

  19 DAYS AFTER PRIMARY THE SURGEON REVISED THE PATIENT HIP FOR A STEM SUBSIDENCE. THE REASON OF SUBSIDENCE IS UNKNOWN. STEM, HEAD AND LINER SWAP. THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: No Code Available

  MAUDE report 8004511 ↗
• InjuryMay 23, 2018Fracture; Device Dislodged or Dislocated

  THREE DAYS AFTER PRIMARY THE SURGEON REVISED THE STEM, THE HEAD AND THE LINER FOR A HIP DISLOCATION AND FEMUR FRACTURE. THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: Hip Fracture; Joint Disorder

  MAUDE report 7536826 ↗
• InjuryJan 19, 2018Fracture

  THREE DAYS AFTER THE STEM REVISION THE SURGEON DETECTED A FEMUR FRACTURE AND REVISED THE PATIENT A SECOND TIME APPLYING THREE CERCLAGE. NO IMPLANTS SWAP. THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: Bone Fracture(s)

  MAUDE report 7206125 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K093944, K250450. 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