Quadra H femoral stems 01.12.028Recalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 07630030802096), received between Nov 9, 2017 and Dec 22, 2020 — classified as 3 injuries, 2 malfunctions.

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

1 other recall cover devices cleared under the same FDA submission (K082792, 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 5 most recent of 5 reports, in the reporter's own words as published by the FDA.

• InjuryDec 22, 2020Fracture; Appropriate Device Problem Term/Code Not Available

  REVISION SURGERY PERFORMED DUE TO PERIPROSTHETIC FEMUR BONE FRACTURE, OSTEOLYSIS WAS VISIBLE. THE PRIMARY SURGERY WAS PERFORMED ON (B)(6) 2014.

  Patient problems: Bone Fracture(s); Osteolysis

  MAUDE report 11053923 ↗
• InjuryDec 15, 2020Migration or Expulsion of Device; Appropriate Device Problem Term/Code Not Available

  4 DAYS AFTER THE PRIMARY SURGERY, THE STEM SLID A LITTLE BIT DEEPER INTO THE BONE. ON X-RAYS A LONGITUDINAL FRACTURE OF THE FEMUR WAS DISCOVERED. THE SURGEON EXPLANTED THE STEM AND HE DID 5 CERCLAGES AROUND THE FEMUR AND IMPLANTED A QUADRA R STEM SIZE 6.

  Patient problems: Bone Fracture(s)

  MAUDE report 11009860 ↗
• InjuryDec 15, 2017Loose or Intermittent Connection

  9 YEARS AFTER PRIMARY REVISION SURGERY FOR STEM LOOSENING. THE SURGEON REVISED ALL THE IMPLANT SUCCESSFULLY.

  Patient problems: Joint Disorder

  MAUDE report 7121400 ↗
• MalfunctionNov 17, 2017Packaging Problem; Packaging Problem

  THE STEM WAS LOOSE IN THE PACK. THE PACK HAS A DAMAGE BECAUSE OF THE IMPINGEMENT WITH THE STEM. A SECOND IMPLANT WAS USED TO COMPLETE THE SURGERY.

  Patient problems: No Information

  MAUDE report 7040115 ↗
• MalfunctionNov 9, 2017Packaging Problem; Packaging Problem

  DURING SURGERY IT WAS NOTICED THAT THE STEM IS OUT OF THE FOAM. THE SURGEON DIDN'T USE THE IMPLANT. THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7013789 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K082792, 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