Quadra H femoral stems 01.12.033Recalls & reported problems

Summary

The FDA's MAUDE database contains 20 adverse event reports that list this exact device (DI 07630030802157), received between Sep 7, 2017 and Apr 23, 2026 — classified as 20 injuries.

The most frequently reported specific device problem is “Osseointegration Problem” (8 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 20 most recent of 20 reports, in the reporter's own words as published by the FDA.

• InjuryApr 23, 2026Osseointegration Problem

  PRIMARY SURGERY PERFORMED ON (B)(6) 2012. ON (B)(6) 2026 (13 YEARS AND 3 MONTHS POST PRIMARY) REVISION SURGERY ON THE RIGHT-SIDE HIP PERFORMED FOR LOOSENING OF THE STEM. HEAD AND STEM REVISED. SUCCESSFULLY. NO LOOSENING OF THE ACETABULAR SHELL. NO INFECTION.

  Patient problems: Aseptic loosening

  MAUDE report 24964784 ↗
• InjuryNov 10, 2025Device Appears to Trigger Rejection; Osseointegration Problem; Device Appears to Trigger Rejection; Osseointegration Problem

  AFTER 9 YEARS AND 2 MONTHS, THE PATIENT PRESENTED WITH THIGH PAIN. X-RAYS REVEALED STEM LOOSENING. THE CERAMIC HEAD WAS REMOVED AND INSPECTED, SHOWING WEAR ON THE EDGE. THE STEM SURFACE SHOWED VERY LITTLE BONE ATTACHMENT, AND PUS WAS NOTED AROUND THE EDGE OF THE STEM. THE ACETABULAR SHELL WAS SUBSEQUENTLY REMOVED USING THE EXPLANT SYSTEM. ADDITIONAL PUS WAS COLLECTED FROM THE BACKSIDE OF THE SHELL. THE SURGEON NOTED THAT THE SHELL APPEARED WELL INTEGRATED INTO THE ACETABULAR BONE. THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: Joint Impingement; Septic loosening

  MAUDE report 23510649 ↗
• InjuryMay 13, 2025Osseointegration Problem; Osseointegration Problem

  AT ABOUT 2 YEARS AND 1 MONTH AFTER PRIMARY, THE PATIENT HAS BEEN REVISED BECAUSE OF ASEPTIC LOOSENING. THE SURGEON STATED THAT, DUE TO THE SHAPE OF STEM, THERE WERE SOME FIXATION POINTS BUT THE STEM WAS STILL MOBILE. STEM AND HEAD WERE REMOVED AND A LARGEST SIZE OF UNCEMENTED STEM, IN ORDER TO OPTIMIZE FIXATION POINTS IN THE FEMORAL CANAL, WAS USED. SURGERY COMPLETED SUCCESSFULLY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22008321 ↗
• InjuryMay 23, 2024Osseointegration Problem; Osseointegration Problem

  AT ABOUT 14 YEARS AFTER PRIMARY, THE PATIENT HAS BEEN REVISED BECAUSE OF ASEPTIC LOOSENING. THE SURGERY HAS BEEN COMPLETED SUCCESSFULLY.

  Patient problems: Inadequate Osseointegration

  MAUDE report 19380010 ↗
• InjuryDec 14, 2023Osseointegration Problem; Osseointegration Problem

  REVISION SURGERY AT ABOUT 10 YEARS 9 MONTHS POST-PRIMARY DUE TO STEM LOOSENING. PATIENT HAD REPORTED THIGH PAIN. QUADRA H REMOVED AND COMPETITOR CEMENTED STEM IMPLANTED.

  Patient problems: Inadequate Osseointegration

  MAUDE report 18324592 ↗
• InjuryOct 27, 2023Device Appears to Trigger Rejection; Osseointegration Problem; Device Appears to Trigger Rejection; Osseointegration Problem

  AT ABOUT 1 YEAR AFTER THE PRIMARY, THE PATIENT HAS BEEN REVISED BECAUSE OF A CITROBACTER KOSERI INFECTION AND STEM LOOSENING. ALL IMPLANTS WERE REMOVED AND A G SPACER HAS BEEN PUT IN PLACE.

  Patient problems: Inadequate Osseointegration; Unspecified Infection

  MAUDE report 18020076 ↗
• InjuryAug 3, 2022Loss of Osseointegration; Loss of Osseointegration

  REVISION SURGERY AT ABOUT 2 YEARS AND 1 MONTH FROM PRIMARY. THE STEM WAS FIXED DISTALLY, SIGNS OF OSTEOLYSIS WERE VISIBLE AROUND THE STEM. THE STEM WAS REVISED AND THE SURGERY COMPLETED SUCCESSFULLY.

  Patient problems: Osteolysis

  MAUDE report 15156481 ↗
• InjuryJul 25, 2022Osseointegration Problem

  REVISION SURGERY PERFORMED AFTER ABOUT 5 YEARS DUE TO STEM MOBILIZATION. THE PATIENT ALREADY UNDERWENT REVISION SURGERY DUE TO HIP LUXATION IN 2018 WHERE A DOUBLE MOBILITY SYSTEM WAS IMPLANTED.

  Patient problems: Inadequate Osseointegration

  MAUDE report 15092008 ↗
• InjuryJul 6, 2022Osseointegration Problem; Osseointegration Problem

  AT ABOUT 5 YEARS FROM THE PRIMARY SURGERY, REVISION SURGERY HAS BEEN PERFORMED FOR STEM LOOSENING. STEM, HEAD AND LINER REVISED SUCCESSFULLY.

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

  MAUDE report 14929526 ↗
• InjuryMar 10, 2021Loose or Intermittent Connection; Appropriate Device Problem Term/Code Not Available

  REVISION SURGERY 4 YEARS AND 10 MONTHS AFTER PRIMARY, FOR STEM LOOSENING. STEM, HEAD AND LINER REVISED SUCCESSFULLY.

  Patient problems: Inadequate Osseointegration

  MAUDE report 11453191 ↗
• InjuryJan 7, 2021Loose or Intermittent Connection

  REVISION SURGERY 4 YEARS AND 3 MONTHS AFTER PRIMARY FOR STEM LOOSENING. QUADRA H REPLACED WITH QUADRA C. THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: Inadequate Osseointegration

  MAUDE report 11129987 ↗
• InjuryOct 16, 2020Material Deformation; Naturally Worn

  REVISION SURGERY PERFORMED AFTER 13 YEARS AND 10 MONTHS FROM THE PRIMARY SURGERY DUE TO STEM MOBILIZATION. THE STEM AND INSERT WERE REVISED. DURING THE REVISION SURGERY, IT WAS NOTICED THAT THE LINER SEEM TO BE WORN( NOT CENTRALLY). THE SURGEON INFORMED THAT IN THE HISTOLOGY IT WAS FOUND SOME GRANULATION TISSUE WITH POLYETHYLENE WEAR INSIDE AND THAT IN THE PREOPERATIVE X-RAYS YOU CAN SEE THAT THE HEAD IS NOT CENTRAL ANYMORE IN THE CUP. AFTER THE REVISION SURGERY, THE LINER WAS STERILIZED AT 134°C END ARRIVED TO MEDACTA DEFORMED.

  Patient problems: Granuloma

  MAUDE report 10690346 ↗
• InjuryOct 1, 2020Loosening of Implant Not Related to Bone-Ingrowth

  REVISION SURGERY PERFORMED AFTER 1 YEAR AND 5 MONTHS FROM THE PRIMARY SURGERY DUE TO FEMORAL STEM LOOSENING AND INFECTION. ALL IMPLANTS HAVE BEEN REMOVED. IT IS UNKNOWN IF THE INFECTION CAUSED A MOBILIZATION OR ARE SEPARATE EVENTS.

  Patient problems: Inadequate Osseointegration; Unspecified Infection

  MAUDE report 10612477 ↗
• InjuryJun 26, 2020Inadequacy of Device Shape and/or Size; Appropriate Device Problem Term/Code Not Available

  REVISION SURGERY PERFORMED AFTER 1 MONTH FROM THE PRIMARY SURGERY DUE TO LEG LENGTH DISCREPANCY ABOUT 1 CM. THE SURGEON REVISED THE STEM AND BALL HEAD BECAUSE THE PATIENT WASN'T SATISFIED ABOUT THE LEG LENGTH.

  Patient problems: Joint Disorder

  MAUDE report 10198973 ↗
• InjuryMar 27, 2020Mechanical Problem

  REVISION SURGERY PERFORMED 10 MONTHS AFTER THE PRIMARY SURGERY DUE TO THE BIOMECHANICAL PROBLEM OF THE STEM. THE SURGEON REVISED THE STEM, INSERT AND THE BALL HEAD.

  Patient problems: Inadequate Osseointegration

  MAUDE report 9887890 ↗
• InjuryMar 12, 2020Loose or Intermittent Connection

  REVISION SURGERY PERFORMED 1 MONTH AFTER THE PRIMARY DUE TO AN INFECTION. THE HEAD, STEM AND INLAY WERE REVISED AND THE PATHOGEN KIND IS UNKNOWN. THE STEM WAS LOOSE.

  Patient problems: Unspecified Infection

  MAUDE report 9822777 ↗
• InjuryNov 27, 2019Loose or Intermittent Connection

  REVISION SURGERY PERFORMED, AFTER 13 YEARS FROM THE PRIMARY SURGERY, DUE TO STEM LOOSENING.

  Patient problems: Joint Disorder

  MAUDE report 9383327 ↗
• InjuryMar 22, 2019Loose or Intermittent Connection

  ON THE (B)(4) 2019 THE COMPLAINT WAS NOTIFIED REPORTING A REVISION SURGERY SCHEDULED FOR THE (B)(6) 2019. ON THE 28 FEBRUARY 2019 WE BECOME AWARE THAT THE REVISION SURGERY WAS POST PONED ON THE (B)(6) 2019. ON THE (B)(6) 2019 THE BRANCH CONFIRMED THAT THE REVISION SURGERY WAS PERFORMED ON THE (B)(6) 2019. REVISION SURGERY PERFORMED AFTER 8 YEARS AND 8 MONTHS FROM THE PRIMARY SURGERY DUE TO STEM LOOSENING, LEFT SIDE. THE CUP WAS LEFT IN PLACE, LINER, HEAD AND STEM HAVE BEEN REVISED (IMPLANTED A MECTACER CERAMIC LINER 32E, A MECTACER CERAMIC BALL HEAD 32S AND A QUADRA-R STEM SIZE 3).

  Patient problems: Inadequate Osseointegration

  MAUDE report 8443625 ↗
• InjuryMay 11, 2018Device Slipped

  REVISION SURGERY PERFORMED DUE STEM LOOSENING AFTER ABOUT 2 YEARS FROM THE PRIMARY. THE STEM WAS IMPLANTED IN (B)(6) 2016 AND THE PATIENT RETURNED TO THE HOSPITAL WITH SIGNIFICANT STEM SUBSIDENCE AND STEM LOOSENING IN (B)(6) 2018. THE SURGEON REMOVED THE STEM AND HEAD USING THEN A COMPETITOR REVISION SYSTEM .

  Patient problems: No Code Available

  MAUDE report 7506733 ↗
• InjurySep 7, 2017Device Slipped

  THE PATIENT PRESENTED TO THE SURGEON WITH PAINFUL HIP. SCAN AND HIP ASPIRATED REVEALED AN INFECTION. THE REVISION SURGERY WAS COMPLETED THROUGH THE HARDING APPROACH AND ALL COMPONENTS WERE REMOVED. THE FEMORAL STEM WAS LOOSE WITH ONLY SMALL AREAS OF BONE ON GROWTH; THE ACETABULAR COMPONENT WAS WELL FIXED. AN ANTIBIOTIC IMPREGNATED SPACER WAS IMPLANTED.

  Patient problems: Joint Disorder; Pain; Unspecified Infection

  MAUDE report 6847605 ↗

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