Quadra H femoral stems 01.12.34SNRecalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 07630030802744), received between May 29, 2019 and Apr 21, 2023 — classified as 5 injuries.

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

• InjuryApr 21, 2023Osseointegration Problem; Osseointegration Problem

  REVISION SURGERY FOR STEM LOOSENING AT ABOUT 6 YEARS AND 11 MONTHS POST PRIMARY. STEM, HEAD AND LINER REVISED SUCCESSFULLY.

  Patient problems: Implant Pain

  MAUDE report 16785172 ↗
• InjuryApr 7, 2022Fracture

  THE PATIENT CAME IN REPORTING PAIN DUE TO A PERIPROSTHETIC FRACTURE THAT WAS CAUSED FROM FALLING. ABOUT 9 YEARS AND 10 MONTHS AFTER THE PRIMARY SURGERY, THE SURGEON CABLED THE FRACTURE AND REVISED THE STEM, HEAD, AND LINER. THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: Pain

  MAUDE report 14040033 ↗
• InjuryNov 24, 2020Loosening of Implant Not Related to Bone-Ingrowth

  THE PATIENT CAME IN REPORTING PAIN DUE TO A LOOSE STEM. THE CAUSE OF THE LOOSE STEM IS UNKNOWN. THE SURGEON REVISED THE HEAD AND STEM 2 YEARS AND 4 MONTHS AFTER PRIMARY. THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: Pain

  MAUDE report 10895666 ↗
• InjuryJun 19, 2019Loose or Intermittent Connection; Inadequacy of Device Shape and/or Size; Unstable

  ON MAY 22 WE WERE INFORMED ABOUT A REVISION SURGERY PERFORMED ON MAY 23. THE PATIENT HAD HIP PAIN AND WAS INSTABLE. THE PATIENT WAS 1.5CM SHORT ON THE OPERATED SIDE. ONCE INSIDE THE SURGEON NOTICED A LARGE PSEUDOTUMOR AND NUMEROUS SIMILAR MEMBRANES. THE PRIMARY DIAGNOSIS WAS LOOSENING OF THE STEM AS IT APPEARS TO HAVE SUBSIDED CAUSING THE SECONDARY DIAGNOSIS OF INSTABILITY. SO ABOUT 7 MONTHS AFTER PRIMARY THE SURGEON REMOVED THE STEM AND DUE TO THE PSEUDOTUMOR AND REACTION IN THE JOINT HE DECIDED TO ALSO REMOVE THE CUP. THE SURGEON SUGGESTED THAT THERE IS EVIDENCE OF IMPINGEMENT OF THE NECK AND THE SIDE OF THE CUP. ALL MEDACTA COMPONENTS WERE REMOVED AND OTHER COMPANY IMPLANTS WERE IMPLANTED.

  Patient problems: Joint Disorder

  MAUDE report 8711639 ↗
• InjuryMay 29, 2019Loose or Intermittent Connection; Appropriate Device Problem Term/Code Not Available

  ON (B)(4) 2019 WE WERE INFORMED ABOUT A REVISION SURGERY PERFORMED ON (B)(6) 2019, 1.5 YEARS AFTER PRIMARY SURGERY, DUE TO STEM LOOSENING.

  Patient problems: Inadequate Osseointegration

  MAUDE report 8649832 ↗

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