Quadra H femoral stems 01.12.31SNRecalls & reported problems

Summary

The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 07630030802713), received between Jul 14, 2017 and Aug 27, 2026 — classified as 6 injuries.

The most frequently reported specific device problem is “Osseointegration Problem” (5 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 6 most recent of 6 reports, in the reporter's own words as published by the FDA.

• InjuryAug 27, 2026Osseointegration Problem

  Revision surgery performed due to stem loosening about 1 year and 2 months after the primary surgery.

  Patient problems: Aseptic loosening

  MAUDE report 50474969 ↗
• InjuryApr 28, 2026Osseointegration Problem

  REVISION SURGERY DUE TO STEM LOOSENING ABOUT 8 YEARS AND 3 MONTHS AFTER PRIMARY SURGERY. THERE WAS NO INDICATION OF TRAUMA. THE SURGEON MADE NO NOTE OF BONE QUALITY. THE SURGEON REVISED THE MEDACTA STEM AND HEAD TO A COMPETITOR STEM AND HEAD, AND REVISED THE MEDACTA LINER TO A SAME SIZE LINER. THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: Aseptic loosening

  MAUDE report 25012258 ↗
• InjuryAug 30, 2022Device Appears to Trigger Rejection; Osseointegration Problem; Device Appears to Trigger Rejection; Osseointegration Problem

  AT ABOUT 2 MONTHS AFTER THE PRIMARY SURGERY, REVISION WAS PERFORMED DUE TO IMPLANT LOOSENING PROBABLY CAUSED BY A SUSPECTED FRACTURE IN THE FEMUR BONE. ANY FRACTURE WAS NOTICED DURING THE PRIMARY SURGERY. DURING THE REVISION SURGERY A FRACTURE WAS NOTICED BUT THE REASON IS UNKNOWN. THE SURGEON REVISED SUCCESSFULLY THE HEAD WITH A CERAMIC HEAD AND STEM WITH A QUADRA-C STEM AND IMPLANTED A COMPETITOR PLATE.

  Patient problems: Bone Fracture(s); Inadequate Osseointegration

  MAUDE report 15319223 ↗
• InjuryMar 15, 2022Osseointegration Problem; Osseointegration Problem

  AT 13 YEARS 1 MONTH AFTER THE PRIMARY, THE PATIENT CAME IN REPORTING PAIN DUE TO A LOOSE STEM AND THE CAUSE OF THE LOOSE STEM IS UNKNOWN. THE SURGEON REVISED THE STEM AND HEAD WITH COMPETITOR COMPONENTS. THE SURGERY WAS COMPLETED SUCCESSFULLY.

  MAUDE report 13768694 ↗
• InjuryMar 29, 2021Osseointegration Problem; Osseointegration Problem

  REVISION SURGERY 6 YEARS AND 3 MONTHS AFTER PRIMARY FOR STEM MOBILIZATION AND STRESS SHIELDING. THE SURGEON REVISED SUCCESSFULLY THE STEM, HEAD AND LINER. THE STEM CAME OUT EASILY, THE SURGEON IMPLANTED AN X-ACTA STEM.

  Patient problems: Insufficient Information

  MAUDE report 11580731 ↗
• InjuryJul 14, 2017Loose or Intermittent Connection

  THE PATIENT CAME IN COMPLAINING OF PAIN. THE SURGEON DETERMINED THAT THE STEM WAS LOOSE. THE SURGEON REVISED ALL MEDACTA COMPONENTS. THE SURGERY WAS COMPLETED SUCCESSFULLY. X-RAYS ARE AVAILABLE. EXPLANTS ARE NOT AVAILABLE.

  Patient problems: Joint Disorder; Pain

  MAUDE report 6714003 ↗

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