Quadra H femoral stems 01.12.027Recalls & reported problems

Summary

The FDA's MAUDE database contains 7 adverse event reports that list this exact device (DI 07630030802089), received between Nov 17, 2017 and Jul 31, 2025 — classified as 5 injuries, 2 malfunctions.

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 7 most recent of 7 reports, in the reporter's own words as published by the FDA.

• InjuryJul 31, 2025Loss of Osseointegration; Loss of Osseointegration

  REVISION SURGERY PERFORMED AT ABOUT 4 YEARS 3 MONTHS AFTER PRIMARY DUE TO QUADRA-H CEMENTLESS LAT LOOSENING. STEM WAS REMOVED BY MINIMAL FORCE OF EXTRACTION. CUP OSTEOINTEGRATION WAS TESTED WITH A MODERATE IMPACTION AND IT FELL OUT IMMEDIATELY. THE SURGEON REVISED ALL COMPONENTS WITH COMPETITOR'S.

  Patient problems: Inadequate Osseointegration

  MAUDE report 22673489 ↗
• InjurySep 20, 2021Osseointegration Problem; Osseointegration Problem

  THE PATIENT CAME IN REPORTING PAIN. REVISION SURGERY WAS PERFORMED 7 YEARS AND 10 MONTHS AFTER THE PRIMARY SURGERY DUE TO STEM MOBILIZATION.

  Patient problems: Pain

  MAUDE report 12494937 ↗
• InjuryMar 5, 2021Failure to Osseointegrate

  REVISION SURGERY PERFORMED DUE TO SUBCLINICAL STEM MOBILIZATION 2 YEARS AND 7 MONTHS AFTER THE PRIMARY SURGERY. MINIMAL RADIOLUCENT LINES WERE VISIBLE ON THE X-RAY. THE STEM AND THE CUP WERE REVISED. THERE WAS NO PROBLEM WITH THE CUP, IT WAS REVISED BECAUSE THE SURGEON DIDN'T LIKE THE X-RAY WITH THE SCREWS WHICH WERE FIXING THE CUP.

  Patient problems: Inadequate Osseointegration

  MAUDE report 11419746 ↗
• InjuryAug 20, 2020Microbial Contamination of Device; Appropriate Device Problem Term/Code Not Available

  REVISION SURGERY PERFORMED AFTER 1 YEAR AND 4 MONTHS AFTER PRIMARY SURGERY DUE TO CHRONIC INFECTION. THE SURGEON REVISED ALL PROSTHESIS. THE REVISION WAS SUCCESSFULLY COMPLETED VIA POSTERIOR APPROACH AND A CEMENT SPACER WAS INSERTED. THE PATHOGEN WAS STREPTOCOCCUS MITIS.

  Patient problems: Unspecified Infection

  MAUDE report 10430567 ↗
• InjuryJun 25, 2019Loose or Intermittent Connection

  ABOUT 2 YEARS AND 8 MONTHS AFTER PRIMARY THE SURGEON REVISED THE PATIENT HIP, FOR A STEM LOOSENING. STEM, HEAD AND LINER REVISED SUCCESSFULLY. THE PATIENT PRESENTED ALSO A STEM LENGTH DISCREPANCY.

  Patient problems: Inadequate Osseointegration

  MAUDE report 8731006 ↗
• MalfunctionJul 31, 2018Mechanical Problem

  THE DISTAL PART OF THE STEM WENT OUT OF ITS FOAM. THE STEM WAS NOT USED AND IT WAS REPLACED WITH A NEW ONE.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7734724 ↗
• MalfunctionNov 17, 2017Packaging Problem; Packaging Problem

  THE STEM WAS LOOSE IN THE PACK. THE PACK HAS A DAMAGE BECAUSE OF THE IMPINGEMENT WITH THE STEM. A SECOND IMPLANT WAS USED TO COMPLETE THE SURGERY.

  Patient problems: No Information

  MAUDE report 7040110 ↗

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