Quadra H femoral stems 01.12.32SNRecalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 07630030802720), received between Aug 18, 2017 and Sep 16, 2022 — classified as 5 injuries.

The most frequently reported specific device problem is “Failure to Osseointegrate” (1 report).

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 5 most recent of 5 reports, in the reporter's own words as published by the FDA.

• InjurySep 16, 2022Osseointegration Problem; Osseointegration Problem

  AT ABOUT 5 YEARS AND 4 MONTHS AFTER THE PRIMARY SURGERY, THE PATIENT CAME IN REPORTING PAIN DUE TO A LOOSE STEM AND THE CAUSE OF THE LOOSE STEM IS UNKNOWN. THE SURGEON REVISED THE MEDACTA HEAD AND STEM WITH COMPETITOR COMPONENTS AND REVISED THE MEDACTA LINER WITH A MEDACTA LINER. THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available

  MAUDE report 15439028 ↗
• InjuryMay 9, 2022Failure to Osseointegrate; Failure to Osseointegrate

  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, HEAD, AND LINER 5 YEARS AND 6 MONTHS AFTER PRIMARY. THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: Joint Laxity; Pain

  MAUDE report 14336935 ↗
• InjuryNov 6, 2019Fracture

  THE PATIENT CAME IN COMPLAINING OF PAIN DUE TO A FRACTURE DISTAL TO THE TIP OF THE STEM. THE CAUSE OF THE FRACTURE IS UNKNOWN. THE SURGEON CABLED THE FRACTURE AND REVISED THE MEDACTA HEAD AND STEM WITH COMPETITOR ITEMS 3 WEEKS AFTER PRIMARY. THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: Hip Fracture

  MAUDE report 9283650 ↗
• InjuryDec 15, 2017Loose or Intermittent Connection

  THREE (3) YEARS AFTER PRIMARY THE SURGEON DETECTED A STEM PROXIMAL ASEPTIC LOOSENING WITH DISTAL FIXATION.

  Patient problems: Joint Disorder

  MAUDE report 7121388 ↗
• InjuryAug 18, 2017Insufficient Device Problem Information

  THE PATIENT HAS PAIN DUE TO THE LEG LENGTH DISCREPANCY. THE SURGEON STATED THE OPERATED LEG IS TOO LONG AND REVISED IT.

  Patient problems: Joint Disorder; Pain

  MAUDE report 6803622 ↗

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