Quadra H femoral stems 01.12.026Recalls & reported problems

Summary

The FDA's MAUDE database contains 12 adverse event reports that list this exact device (DI 07630030802072), received between Sep 20, 2017 and Sep 16, 2021 — classified as 11 injuries, 1 malfunction.

The most frequently reported specific device problem is “Loose or Intermittent Connection” (3 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 12 most recent of 12 reports, in the reporter's own words as published by the FDA.

• InjurySep 16, 2021Loose or Intermittent Connection; Appropriate Device Problem Term/Code Not Available

  REVISION SURGERY PERFORMED 4 YEARS AND 8 MONTHS AFTER THE PRIMARY SURGERY DUE TO STEM LOOSENING.

  Patient problems: Inadequate Osseointegration

  MAUDE report 12479679 ↗
• InjuryFeb 24, 2021Osseointegration Problem; Osseointegration Problem

  REVISION SURGERY 8 YEARS AND 10 MONTHS AFTER PRIMARY FOR SUSPECTED LOOSENING. DURING THE REVISION THE STEM CAME OUT EASILY. NO INFECTION DETECTED. THE SURGERY WAS COMPLETED SUCCESSFULLY, STEM, HEAD AND LINER REVISED SUCCESSFULLY.

  Patient problems: Insufficient Information

  MAUDE report 11371319 ↗
• InjuryNov 18, 2020Therapeutic or Diagnostic Output Failure

  THE PATIENT HAS BEEN COMPLAINING OF LEG PAIN FOR ABOUT 6 WEEKS. AFTER AN INVESTIGATION WITH RADIOLOGY AND SCINTIGRAPHY, IT WAS DECIDED TO CHANGE THE SHAFT TO QUADRA R (4 YEARS AND 2 MONTHS AFTER PRIMARY SURGERY).

  Patient problems: Pain

  MAUDE report 10860234 ↗
• InjuryOct 16, 2020Adverse Event Without Identified Device or Use Problem

  THE PATIENT CAME IN, 11 YEARS AND 8 MONTHS AFTER PRIMARY SURGERY, REPORTING PAIN AND THE CAUSE OF THE PAIN IS UNKNOWN. THE SURGEON REVISED THE QUADRA H STD SIZE 6 STEM, FEMORAL HEAD AND DM LINER. THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: Pain

  MAUDE report 10689733 ↗
• InjuryJun 17, 2020Loosening of Implant Not Related to Bone-Ingrowth

  REVISION SURGERY WAS PERFORMED 8 YEARS AFTER PRIMARY ON A PATIENT WITH SUSPECTED LOOSENING OF QUADRA H IMPLANT. X-RAYS SHOWED RADIOLUCENT LINES. NO SIGNS OF INFECTION. STEM AND HEAD WERE REVISED. STEM WAS EASY TO REMOVE.

  Patient problems: Joint Disorder

  MAUDE report 10161543 ↗
• InjuryMar 13, 2020Adverse Event Without Identified Device or Use Problem

  REVISION SURGERY ABOUT 3 MONTHS AFTER PRIMARY FOR INFECTION. THE PATIENT CAME BACK WITH AN ABSCESS ON THE ANTERIOR PART OF THE THIGH AND AN EPIDERMAL GERM WHICH HAVE LED TO TWO PUNCTURES. ALL HIP HARDWARE REVISED SUCCESSFULLY.

  Patient problems: Unspecified Infection

  MAUDE report 9829930 ↗
• InjuryFeb 25, 2020Adverse Event Without Identified Device or Use Problem

  REVISION SURGERY OF QUADRA SIZE 6 STD STEM FOR PAIN 10 YEARS AND 11 MONTHS AFTER THE PRIMARY. RADIOLUCENT LINES ARE VISIBLE IN PROXIMAL MEDIAL AND LATERAL SECTION OF THE FEMUR AND ANTERIOR AND POSTERIOR SECTION ON AXIAL XRAY, ASEPTIC LOOSENING MAY BE PRESENT. THE STEM WAS DISTALLY STABLE BUT HAD TO BE REMOVED DUE TO COMPLAINT OF PAIN FROM THE PATIENT. THE STEM WAS SUCCESSFULLY REMOVED.

  Patient problems: Inadequate Osseointegration

  MAUDE report 9750251 ↗
• InjuryAug 9, 2019Loose or Intermittent Connection

  REVISION SURGERY AFTER 1 YEAR AND 7 MONTHS FROM THE PRIMARY DUE TO PAIN CAUSED BY A LOOSE STEM. THE SURGEON REVISED THE STEM SUCCESSFULLY.

  Patient problems: Inadequate Osseointegration

  MAUDE report 8877720 ↗
• InjuryMay 3, 2019Appropriate Device Problem Term/Code Not Available

  ABOUT 2 YEARS AND 9 MONTHS AFTER PRIMARY THE SURGEON REVISED THE PATIENT HIP FOR A SUSPECTED INFECTION. THE STEM COME OUT EASY FROM FEMUR DURING THE REVISION. THE STEM WAS REVISED. THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: Joint Disorder

  MAUDE report 8577873 ↗
• InjuryMar 22, 2018Loose or Intermittent Connection

  SURGEON NOTIFIED ON 20 FEBRUARY 2018 SALES REPRESENTATIVE THAT HE THOUGHT THE STEM LOOKED LOOSE. SURGEON PERFORMED REVISION SURGERY ON (B)(6) 2018. DURING THE CASE IT BECAME OBVIOUS THERE WAS A SEVERE INFECTION. THE STEM WAS ABLE TO BE PULLED OUT BY HAND QUITE EASILY. SURGEON THEN DECIDED TO REVISE THE CUP AS WELL IN ORDER TO DO A FULL WASH OUT. ON 26 FEBRUARY 2018 SALES REPRESENTATIVE REPORTED: THE SURGEON CONFIRMED THAT THERE WAS AN INFECTION. IT IS NOT POSSIBLE SAY WITH 100 PERCENT CERTAINTY IT CAUSED THE LOOSENING BUT IT IS MOST LIKELY. THE REMOVAL OF CUP DEFINITELY DUE TO INFECTION AS IT WAS A PRECAUTION DUE TO THE INFECTION.

  Patient problems: Joint Disorder; Unspecified Infection

  MAUDE report 7360999 ↗
• MalfunctionNov 10, 2017Packaging Problem; Packaging Problem

  THE STEM WAS LOOSE IN THE PACK AND IT WAS DAMAGED DUE TO THE IMPINGEMENT WITH THE PACK ITSELF. THE SURGEON HAD MORE THAN ONE STEM OF THIS SIZE, SO HE USED AN OTHER ONE.

  Patient problems: No Information

  MAUDE report 7018002 ↗
• InjurySep 20, 2017Adverse Event Without Identified Device or Use Problem

  REVISION PERFORMED DUE TO LOW GRADE INFECTION.

  Patient problems: Unspecified Infection

  MAUDE report 6878305 ↗

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