Quadra H femoral stems 01.12.036Recalls & reported problems

Summary

The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 07630030802188), received between Dec 22, 2017 and Jul 2, 2025 — classified as 5 injuries, 1 malfunction.

The most frequently reported specific device problem is “Loosening of Implant Not Related to Bone-Ingrowth” (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 6 most recent of 6 reports, in the reporter's own words as published by the FDA.

• InjuryJul 2, 2025Loss of Osseointegration; Loss of Osseointegration

  REVISION DUE TO ASEPTIC STEM LOOSENING PERFORMED ABOUT 5 YEARS AND 3 MONTHS AFTER THE PRIMARY SURGERY. STEM, HEAD, AND LINER REVISED.

  Patient problems: Aseptic loosening

  MAUDE report 22380967 ↗
• MalfunctionMar 19, 2025Osseointegration Problem; Osseointegration Problem

  THE PATIENT HAS MINIMAL PAIN AND PRESENTS SIGNS OF LOOSENING/STRESS SHIELDING. NO REVISION SURGERY IS PLANNED.

  Patient problems: Inadequate Osseointegration; Pain

  MAUDE report 21640390 ↗
• InjuryNov 30, 2021Appropriate Device Problem Term/Code Not Available; Loosening of Implant Not Related to Bone-Ingrowth

  THE LOOSENING OF THE CUP WAS NOTICED IN A CONTROL X-RAY, THE LOOSENING OF THE STEM WAS NOTICED DURING SURGERY. LOOSENING WAS MAYBE DUE TO A TRAUMA OF THE PATIENT. REVISION SURGERY WAS PERFORMED 15 YEARS AND 2 MONTHS AFTER PRIMARY, ALL IMPLANTS WERE REPLACED.

  Patient problems: Inadequate Osseointegration

  MAUDE report 12891360 ↗
• InjuryMar 24, 2021Osseointegration Problem; Osseointegration Problem

  STEM LOOSENING 12 YEARS AND 2 MONTHS AFTER THE PRIMARY SURGERY. NO REVISION HAS BEEN PERFORMED AT THE MOMENT.

  Patient problems: Inadequate Osseointegration

  MAUDE report 11560724 ↗
• InjuryJan 13, 2020Loosening of Implant Not Related to Bone-Ingrowth; Loosening of Implant Not Related to Bone-Ingrowth

  REVISION SURGERY WILL BE PERFORMED IN (B)(6) 2020 DUE TO STEM LOOSENING.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9580421 ↗
• InjuryDec 22, 2017Device Slipped

  PATIENT REPORTED PAIN.THE SURGEON DETERMINED IT LOOKED LOOSE. PERFORMED REVISION SURGERY AND FOUND THAT THE STEM WAS LOOSE

  Patient problems: Joint Disorder

  MAUDE report 7142938 ↗

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