Quadra H femoral stems 01.12.24SNRecalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 07630030802645), received between Jan 4, 2019 and Mar 9, 2020 — classified as 2 injuries, 1 malfunction.

The most frequently reported specific device problem is “Contamination /Decontamination Problem” (1 report).

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 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• InjuryMar 9, 2020Loose or Intermittent Connection; Appropriate Device Problem Term/Code Not Available

  REVISION SURGERY AFTER 2 YEARS AND 9 MONTHS FROM THE PRIMARY DUE TO MID -DISTAL LOOSENING OF THE HIP STEM. THE SURGEON REVISED THE STEM.

  Patient problems: Joint Disorder

  MAUDE report 9805217 ↗
• InjuryDec 2, 2019Migration; Migration

  THE PATIENT CAME IN, 2.5 YEARS AFTER PRIMARY SURGERY, COMPLAINING OF INSTABILITY DUE TO A SUBSIDED STEM. THE CAUSE OF THE SUBSIDED STEM IS UNKNOWN. THE SURGEON REVISED THE STEM, HEAD, AND LINER AND THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: No Code Available

  MAUDE report 9393526 ↗
• MalfunctionJan 4, 2019Contamination /Decontamination Problem

  DURING THE PRIMARY HIP SURGERY AND AFTER THE STEM WAS IMPLANTED, THE SURGEON NOTICED A FOREIGN SUBSTANCE ON THE NECK OF THE STEM. THE SURGEON EXPLANTED THE SIZE 4 QUADRA H STEM AND REPLACED IT WITH ANOTHER SIZE 4 QUADRA H STEM. THIS CAUSED A 5 MINUTE DELAY IN THE CASE AND THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: No Code Available

  MAUDE report 8217190 ↗

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