Quadra H femoral stems 01.12.022Recalls & reported problems

Summary

The FDA's MAUDE database contains 26 adverse event reports that list this exact device (DI 07630030802034), received between Sep 8, 2017 and Apr 30, 2026 — classified as 26 injuries.

The most frequently reported specific device problem is “Osseointegration Problem” (10 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 25 most recent of 26 reports, in the reporter's own words as published by the FDA.

• InjuryApr 30, 2026Osseointegration Problem

  REVISION SURGERY DUE TO STEM LOOSENING (POSSIBLE POTTING OF THE STEM) AFTER ABOUT 1 YEAR AND 7 MONTHS FROM PRIMARY SURGERY. ONE MONTH AFTER THE PRIMARY SURGERY, THE PATIENT UNDERWENT AN ARTHROSCOPIC TENDON RELEASE TO RELIEVE PAIN, BUT THE PROCEDURE DID NOT PRODUCE THE DESIRED RESULTS. REVISION SURGERY WAS THEN PLANNED AND THE STEM WAS REMOVED, KEEPING THE CUP AND LINER IN THE PATIENT. A COMPETITOR STEM AND HEAD WAS THEN IMPLANTED.

  Patient problems: Aseptic loosening

  MAUDE report 25039771 ↗
• InjuryMar 13, 2026Osseointegration Problem

  THE PATIENT REPORTED MID-THIGH PAIN AND DIAGNOSTIC TESTS REVEALED SPACES AROUND THE STEM. AT ABOUT 10 YEARS AND 9 MONTHS AFTER THE PRIMARY, A REVISION SURGERY WAS PERFORMED DUE TO STEM LOOSENING. THE SURGEON REMOVED THE STEM WITH MINIMAL EFFORT. NO SIGNS OF INFECTION WERE OBSERVED. A COMPETITOR CEMENTED STEM WAS IMPLANTED. THE CERAMIC LINER WAS REMOVED AND REPLACED WITH A POLYETHYLENE LINER, ACCORDING TO THE SURGEON`S PREFERENCE. THE CUP REMAINED IN SITU.

  Patient problems: Aseptic loosening; Inadequate Osseointegration

  MAUDE report 24588557 ↗
• InjuryJul 16, 2024Osseointegration Problem; Osseointegration Problem

  AT ABOUT 7 YEARS 11 MONTHS AFTER THE PRIMARY, REVISION SURGERY PERFORMED DUE TO ASEPTIC STEM LOOSENING (RIGHT SIDE). ALL COMPONENTS WERE SUCCESSFULLY REVISED. QUADRA-H WAS REVISED WITH QUADRA-R.

  Patient problems: Inadequate Osseointegration

  MAUDE report 19749802 ↗
• InjuryMay 24, 2024Osseointegration Problem; Osseointegration Problem

  AT ABOUT 2 YEARS AND 1 MONTH AFTER PRIMARY THE PATIENT HAS BEEN REVISED BECAUSE OF STEM ASEPTIC LOOSENING. ACCORDING TO SURGEON, THE POSSIBLE CAUSE COULD BE THE UNDERSIZED OF THE STEM AND THE WEIGHT OF THE PATIENT. ALL COMPONENTS REVISED SUCCESSFULLY.

  Patient problems: Inadequate Osseointegration

  MAUDE report 19390101 ↗
• InjuryDec 21, 2023Osseointegration Problem; Osseointegration Problem

  AT ABOUT 7 YEARS AND 8 MONTHS AFTER PRIMARY, THE PATIENT HAS BEEN REVISED BECAUSE OF STEM LOOSENING. THE SURGERY HAS BEEN COMPLETED SUCCESSFULLY.

  Patient problems: Inadequate Osseointegration

  MAUDE report 18372070 ↗
• InjurySep 13, 2023Osseointegration Problem; Osseointegration Problem

  REVISION SURGERY 10 YEARS AND 8 MONTHS POST PRIMARY FOR QUADRA H LOOSENING. MINIMAX IMPLANTED SUCCESSFULLY.

  Patient problems: Implant Pain

  MAUDE report 17734819 ↗
• InjuryApr 11, 2022Osseointegration Problem; Osseointegration Problem

  REVISION SURGERY AT 3 YEARS AND 2 MONTHS POST PRIMARY FOR STEM LOOSENING. THE STEM, HEAD AND LINER HAVE BEEN REVISED SUCCESSFULLY.

  Patient problems: Insufficient Information

  MAUDE report 14071195 ↗
• InjuryJan 13, 2022Osseointegration Problem; Osseointegration Problem

  AT 15 YEARS AFTER THE PRIMARY SURGERY, A REVISION SURGERY WAS PERFORMED DUE TO STEM MOBILIZATION.

  Patient problems: Failure of Implant

  MAUDE report 13250697 ↗
• InjuryDec 17, 2021Osseointegration Problem; Osseointegration Problem

  ON (B)(6) 2021 THE SURGEON PERFORMED REVISION SURGERY DUE TO STEM MOBILIZATION. THE PRECISE PRIMARY DATE IS UNKNOWN IT WAS PERFORMED IN 2015.

  Patient problems: Insufficient Information

  MAUDE report 13025105 ↗
• InjuryNov 26, 2021Unintended Movement

  AT 13 YEARS AFTER THE PRIMARY, REVISION SURGERY WAS PERFORMED DUE TO STEM AND CUP MOBILIZATION.

  Patient problems: Inadequate Osseointegration

  MAUDE report 12878086 ↗
• InjurySep 16, 2021Loose or Intermittent Connection; Appropriate Device Problem Term/Code Not Available

  REVISION OF A QUADRA H DUE TO LOOSENING, PAIN. THE CAUSE OF LOOSENING IS NOT KNOWN. HEAD AND STEM WERE REVISED 4 YEARS AFTER THE PRIMARY SURGERY.

  Patient problems: Inadequate Osseointegration

  MAUDE report 12479677 ↗
• InjuryFeb 18, 2021Osseointegration Problem; Osseointegration Problem

  REVISION FOR STEM LOOSENING, THE DATE OF PRIMARY SURGERY IS UNKNOWN. NO FURTHER INFORMATION ARE AVAILABLE.

  Patient problems: Insufficient Information

  MAUDE report 11341922 ↗
• InjuryOct 28, 2020Loose or Intermittent Connection; Appropriate Device Problem Term/Code Not Available

  REVISION SURGERY PERFORMED, 19 DAYS AFTER PRIMARY SURGERY, DUE TO STEM LOOSENING. THE STEM, HEAD, AND INLAY HAVE BEEN EXPLANTED.

  Patient problems: Inadequate Osseointegration

  MAUDE report 10746078 ↗
• InjuryOct 23, 2020Insufficient Device Problem Information

  REVISION SURGERY 9 YEARS AND 11 MONTHS AFTER PRIMARY SURGERY FOR IMPINGEMENT OF MEDACTA DEVICES WITH THE ACETABULAR SHELL OF COMPETITOR. THE SURGEON REVISED SUCCESSFULLY THE MEDACTA STEM AND HEAD.

  Patient problems: Insufficient Information

  MAUDE report 10725241 ↗
• InjuryJul 21, 2020Difficult to Remove; Loosening of Implant Not Related to Bone-Ingrowth

  1 YEAR AND 3 MONTHS AFTER THE PRIMARY SURGERY THE SURGEON HAD PLANNED TO REMOVE THE FEMORAL STEM THAT HAD SUBSIDED DUE TO WHAT HE SUSPECTED WAS UNDERSIZING OF THE IMPLANT. AFTER 2 HOURS OF TRYING TO REMOVE THE STEM HE WAS UNABLE TO REMOVE THE WELL FIXED STEM SO IT WAS LEFT IN SITU AND SUBSEQUENTLY HE CHANGED THE FEMORAL HEAD FROM A 36MM +0 TO A 36MM +7. THE SURGEON CONFIRMED THAT THE STEM WAS SUBSIDED BUT IS NOT SURE IF THE REASON IS UNDERSIZED STEM.

  Patient problems: Joint Disorder

  MAUDE report 10300533 ↗
• InjuryJul 16, 2020Unstable

  REVISION OF A QUADRA H STEM FOR CHRONIC INSTABILITY 11 YEARS AND 6 MONTHS AFTER PRIMARY. ALSO THE HEAD HAS BEEN EXPLANTED. IT IS ALSO REPORTED PROBLEM OF INTEGRATION OF THE PRIMARY STEM. PAINFUL PATIENT SINCE PRIMARY SURGERY BUT VERY RESISTANT TO PAIN.

  Patient problems: Joint Disorder

  MAUDE report 10282341 ↗
• InjuryJul 3, 2020Appropriate Device Problem Term/Code Not Available

  REVISION SURGERY PERFORMED 12 YEARS AND 5 MONTHS AFTER THE PRIMARY SURGERY DUE TO PAIN CAUSED BY STEM MOBILIZATION (SCINTIGRAPHY SHOWED ALSO RADIOLUCENCY). IN THE END OF (B)(6), THE STEM GOES DOWN AND THE PAIN IS UNBEARABLE FOR THE PATIENT. THE SURGEON REVISED THE STEM (AMISTEM C) AND BALL HEAD (CERAMIC 32 L) AND IMPLANTED MECTAPLUG SIZE 1.

  Patient problems: Joint Disorder

  MAUDE report 10229107 ↗
• InjuryNov 19, 2019Loosening of Implant Not Related to Bone-Ingrowth; Loosening of Implant Not Related to Bone-Ingrowth

  REVISION SURGERY DUE TO STEM LOOSENING 7 YEARS AND 8 MONTHS AFTER PRIMARY SURGERY.

  Patient problems: Pain

  MAUDE report 9340567 ↗
• InjuryFeb 22, 2019Loose or Intermittent Connection

  ABOUT 4 YEARS AND HALF AFTER PRIMARY THE SURGEON REVISED THE PATIENT HIP FOR STEM LOOSENING. STEM SWAP. THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8361564 ↗
• InjurySep 26, 2018Loose or Intermittent Connection

  THE PATIENT HAD A LOOSE STEM THAT NEEDED TO BE REVISED. THE STEM WAS REMOVED AND A QUADRA C WAS IMPLANTED 4 YEARS AFTER THE PRIMARY SURGERY.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7909554 ↗
• InjuryAug 17, 2018Appropriate Device Problem Term/Code Not Available

  THE PATIENT COMPLAINED HIP PAIN 4 MONTHS AFTER PRIMARY SURGERY. THE SURGEON SUSPECTED AN INFECTION AND REMOVED ALL THE IMPLANTS. NEW IMPLANTS FROM COMPETITORS WILL BE IMPLANTED.

  Patient problems: Pain

  MAUDE report 7793268 ↗
• InjuryJul 6, 2018Loose or Intermittent Connection

  REVISION DUE TO STEM ASEPTIC LOOSENING 4 YEARS AND 8 MONTHS AFTER PRIMARY. VISIBLE HYPERTOPHY OF THE BONE SURROUNDING THE IMPLANT AND LUCENT LINES, AS WELL AS PAIN.

  Patient problems: Failure of Implant; No Code Available; Pain

  MAUDE report 7666257 ↗
• InjuryMay 17, 2018Loose or Intermittent Connection

  ON (B)(6) 2018 WE WERE INFORMED THAT THE SURGEON WILL REVISE ON (B)(6) A PATIENT DUE TO STEM LOOSENING AND INSERT SUSPECTED WEAR.

  Patient problems: Joint Disorder

  MAUDE report 7522298 ↗
• InjuryApr 20, 2018Device Slipped

  REVISION SURGERY PERFORMED DUE TO STEM LOOSENING (RIGHT SIDE) AFTER 6 YEARS AND 3 MONTHS FROM THE PRIMARY.

  Patient problems: Joint Disorder

  MAUDE report 7446811 ↗
• InjuryOct 27, 2017Device Slipped

  REVISION DUE TO STEM LOOSENING. THE STEM WAS COMPLETELY LOOSE AND HAS BEEN REPLACED. LINER AND BALL HEAD HAVE ALSO BEEN REPLACED.

  Patient problems: Joint Disorder

  MAUDE report 6983010 ↗

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