Quadra H femoral stems 01.12.020Recalls & reported problems

Summary

The FDA's MAUDE database contains 8 adverse event reports that list this exact device (DI 07630030802010), received between Apr 26, 2018 and Mar 31, 2026 — classified as 8 injuries.

The most frequently reported specific device problem is “Osseointegration Problem” (4 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 8 most recent of 8 reports, in the reporter's own words as published by the FDA.

• InjuryMar 31, 2026Osseointegration Problem

  REVISION SURGERY DUE TO STEM LOOSENING ABOUT 10 YEARS AND 5 MONTHS AFTER PRIMARY SURGERY.

  Patient problems: Aseptic loosening

  MAUDE report 24741266 ↗
• InjuryFeb 26, 2026Osseointegration Problem

  AT ABOUT 11 YEARS AND 11 MONTHS FROM THE PRIMARY, A REVISION SURGERY WAS PERFORMED DUE TO LOOSENING OF THEMEDACTA MPACT CUP AND QUADRA H STEM.THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: Aseptic loosening; Inadequate Osseointegration

  MAUDE report 24454898 ↗
• InjuryApr 11, 2024Osseointegration Problem; Osseointegration Problem

  AT ABOUT 3 YEARS 8 MONTHS AFTER THE PRIMARY, REVISION SURGERY PERFORMED DUE TO PAIN AND STEM PROXIMALLY LOOSE. STEM AND HEAD REVISED SUCCESSFULLY. THE PATIENT RANGE OF MOTION WAS STABLE ON THE TABLE SO THERE WAS NO NEED TO REVISE THE LINER THAT WAS IN SITU.

  Patient problems: Implant Pain

  MAUDE report 19086079 ↗
• InjuryAug 9, 2023Migration; Migration

  AT ABOUT 2 YEARS AND 4 MONTHS AFTER THE PRIMARY, THE PATIENT HAS BEEN REVISED BECAUSE OF IMPLANT SUBSIDENCE WHICH CAUSED LEG LENGTH DISCREPANCY.

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

  MAUDE report 17486503 ↗
• InjuryDec 15, 2022Osseointegration Problem; Osseointegration Problem

  AT ABOUT 6 YEARS AND 8 MONTHS AFTER THE PRIMARY SURGERY, THE PATIENT WAS REVISED DUE TO STEM LOOSENING. THE SURGEON REVISED SUCCESSFULLY STEM AND HEAD AND REPLACED CUP AND LINER WITH COMPETITOR COMPONENTS.

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

  MAUDE report 15987435 ↗
• InjuryJun 11, 2021Loose or Intermittent Connection

  PRIMARY SURGERY WAS PERFORMED IN 2017, THE EXACT DATE IS NOT AVAILABLE. REVISION SURGERY WAS PERFORMED ON MONDAY, (B)(6) 2021 FOLLOWING STEM LOOSENING. STEM, CUP, AND LINER WERE REVISED SUCCESSFULLY, THE SURGEON KEPT THE HEAD AND SLEEVE.

  Patient problems: Inadequate Osseointegration

  MAUDE report 11981364 ↗
• InjurySep 14, 2018Loose or Intermittent Connection; Scratched Material

  WE WERE INFORMED ON (B)(6) 2018 THAT PATIENT HAS PRESENTED WITH HIP PAIN TO SURGEON. ARTHROGRAM SHOWS DYE TRAVELLING DOWN ONE THIRD OF STEM INDICATING ASCEPTIC LOOSENING. REVISION SURGERY BOOKED FOR (B)(6) 2018. POST REVISION INFO RECEIVED ON THE 30TH AUGUST 2018: CUP WAS WELL FIXED, BUT HE WASN'T HAPPY WITH THE INCLINATION, FEELING IT WAS TOO OPEN. WHEN HE REMOVED IT, SOME BONE COME WITH IT, SO HE ENDED UP USING A COMPETITOR CUP AND SYNTHETIC BONE GRAFT (I HAD LEFT BY THAT STAGE). THE STEM WAS LOOSE AND CAME OUT EASILY USING THE SWORD. HAD ABOUT 2-3MM OF TOGGLE PRIOR TO USING THE REMOVAL TOOLS. THE HEAD HAD SOME SCRATCHES ON THE SURFACE AND SOME WEAR INSIDE.

  Patient problems: Joint Disorder

  MAUDE report 7876583 ↗
• InjuryApr 26, 2018Failure To Adhere Or Bond

  ON (B)(6) 2018 MEDACTA'S CUSTOMER SERVICE HAS BEEN INFORMED ABOUT A REVISION HIP SURGERY, REASON FOR REVISION UNKNOWN. REVISION SURGERY BOOKED (B)(6) 2018. POST REVISION INFORMATION RECEIVED BY MAIL BY SALES REPRESENTATIVE ON THE (B)(4) 2018: THE PATIENT COMPLAINED LONG TERM PAIN. DIAGNOSIS FROM SURGEON IS ASEPTIC LOOSENING OF FEMORAL COMPONENT. ACETABULAR MALPOSITIONING. ANTERIOR WALL DEFICIT. REVISION WAS COMPLETED (B)(6) 2018. STEM GROSSLY LOOSE, REMOVED BY HAND WITH BURNISHING OF DISTAL TIP. ACETABULAR COMPONENT REMOVED . CUP POSITIONED WITH ANTERIOR WALL DEFECT AT INDEX SURGERY.

  Patient problems: Joint Disorder

  MAUDE report 7463814 ↗

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