Quadra S femoral stems 01.12.006Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 07630030801877), received between Aug 21, 2019 and Oct 17, 2019 — classified as 2 injuries.

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

• InjuryOct 17, 2019Loosening of Implant Not Related to Bone-Ingrowth; Loosening of Implant Not Related to Bone-Ingrowth

  REVISION SURGERY PERFORMED AFTER 10 YEARS AND 2 MONTHS FROM THE PRIMARY DUE TO PAIN CAUSED BY A LOOSE STEM. THE SURGEON REVISED THE STEM, HEAD AND LINER SUCCESSFULLY. THE REASON FOR LOOSENING IS UNKNOWN.

  Patient problems: Pain

  MAUDE report 9201324 ↗
• InjuryAug 21, 2019Fracture

  TOTAL HIP PROSTHESIS SURGERY, A POST-OP RX CONTROL SHOWED A COMPOUND FRACTURE AT THE FEMORAL LEVEL. THE SURGEON CABLED THE FRACTURE THE SAME DAY OF THE PRIMARY, NO IMPLANTS HAVE BEEN REVISED. THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: Joint Disorder

  MAUDE report 8914344 ↗

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