Quadra H femoral stems 01.12.031Recalls & reported problems

Summary

The FDA's MAUDE database contains 15 adverse event reports that list this exact device (DI 07630030802133), received between Feb 2, 2018 and May 13, 2026 — classified as 14 injuries, 1 malfunction.

The most frequently reported specific device problem is “Loose or Intermittent Connection” (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 15 most recent of 15 reports, in the reporter's own words as published by the FDA.

• InjuryMay 13, 2026Osseointegration Problem

  REVISION SURGERY DUE TO QUADRA-H LAT LOOSENING ABOUT 5 YEARS AND 2 MONTHS AFTER THE PRIMARY SURGERY. THE STEM WAS EASILY REMOVED WITH FLEXIBLE OSTEOTOMES AND A FABIAN HIP REMOVAL TOOL. THE STEM APPEARED TO HAVE NO HA COATING ON REMOVAL. ONLY STEM AND HEAD REVISED, CUP AND HC PE LINER NOT REMOVED.

  Patient problems: Aseptic loosening

  MAUDE report 25160338 ↗
• MalfunctionMar 19, 2025Osseointegration Problem; Osseointegration Problem

  THE PATIENT HAS SEVERE PAIN AND PRESENTS SIGNS OF LOOSENING/STRESS SHIELDING. CURRENTLY, NO REVISION SURGERY IS PLANNED.

  Patient problems: Inadequate Osseointegration; Pain

  MAUDE report 21640387 ↗
• InjuryMar 19, 2025Osseointegration Problem; Osseointegration Problem

  DURING A FOLLOWUP VISIT THE PATIENT REPORTED SEVERE PAIN. AT ABOUT 7 MONTHS FROM PRIMARY THE SURGEON REVISED THE STEM FOR LOOSENING.

  Patient problems: Pain

  MAUDE report 21640386 ↗
• InjuryJan 8, 2025Loss of Osseointegration; Loss of Osseointegration

  REVISION SURGERY FOR STEM MOBILIZATION AT ABOUT 2 YEARS AND 10 MONTHS POST-PRIMARY. THE SURGEON ATTRIBUTES EARLY LOOSENING TO THE PATIENT BEING NON-COMPLIANT WITH POST-OPERATIVE INSTRUCTIONS AND MOBILIZING INDEPENDENTLY TOO SOON.

  Patient problems: Inadequate Osseointegration

  MAUDE report 21100363 ↗
• InjuryDec 11, 2024Osseointegration Problem; Migration; Osseointegration Problem; Migration

  REVISION SURGERY DUE TO LOOSE AND SUBSIDED (2.4 CM) STEM AT ABOUT 12 YEARS 4 MONTHS FROM PRIMARY. THE SURGEON REVISED THE STEM WITH COMPETITOR'S USING POSTERIOR APPROACH AND THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: Inadequate Osseointegration

  MAUDE report 20900695 ↗
• InjuryNov 26, 2021Break; Break

  AFTER A FALL, THE STEM NECK BROKE, 5 YEARS AND 10 MONTHS AFTER THE PRIMARY SURGERY. THE PATIENT UNDERWENT REVISION SURGERY ON (B)(6) 2017 DUE TO AN UNKNOWN REASON, THEN DUE TO A HIP DISLOCATION TWO CLOSE REDUCTIONS HAS BEEN PERFORMED AND ON (B)(6) 2017 THE XL HEAD WAS REPLACED WITH A 4XL HEAD (IT WAS USED A 4XL SLEEVE NOT FROM MEDACTA) DUE TO AN UNKNOWN REASON.

  Patient problems: Fall

  MAUDE report 12878120 ↗
• InjuryJul 13, 2021Appropriate Device Problem Term/Code Not Available

  5 YEARS AND 3 MONTHS AFTER THE PRIMARY SURGERY THE SURGEON PERFORMED A REVISION DUE TO A MOBILIZED STEM.

  Patient problems: Inadequate Osseointegration

  MAUDE report 12159065 ↗
• InjuryMar 25, 2021Loose or Intermittent Connection

  4 YEARS AND 8 MONTHS AFTER PRIMARY, REVISION SURGERY FOR LOOSE QUADRA H STEM. THE SURGEON REVISED SUCCESSFULLY THE STEM AND HEAD.

  Patient problems: Inadequate Osseointegration

  MAUDE report 11568315 ↗
• InjuryFeb 9, 2021Appropriate Device Problem Term/Code Not Available; Loosening of Implant Not Related to Bone-Ingrowth

  REVISION SURGERY PERFORMED AFTER 6 YEARS FROM THE PRIMARY SURGERY DUE TO ASEPTIC LOOSENING OF THE STEM.

  Patient problems: Inadequate Osseointegration

  MAUDE report 11300315 ↗
• InjuryDec 2, 2019Device Slipped

  REVISION SURGERY PERFORMED 7 YEARS AFTER THE PRIMARY DUE TO INSTABILITY DUE TO A LOOSE STEM. THE SURGEON DECIDED TO REVISE THE PATIENT, AND DURING THE REVISION SURGERY NOTICED THAT THERE WAS NO BONE GROWTH ON THE STEM. THE SURGEON REVISED THE STEM, HEAD, AND LINER AND THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: Joint Disorder

  MAUDE report 9394136 ↗
• InjuryJan 9, 2019Material Fragmentation; Naturally Worn

  REVISION SURGERY PERFORMED 13 YEARS AFTER PRIMARY DUE TO PERI-PROSTHETIC METALLOSIS ON THE PROXIMAL PART OF THE STEM AND ON THE PERIPHERY OF THE NON-MEDACTA CUP. NO INVASION OF THE JOINT CAPSULE. LINER AND HEAD WERE CERAMIC IMPLANTS. THE SURGEON REVISED THE STEM WITH A QUADRA R SIZE 1.

  Patient problems: Failure of Implant

  MAUDE report 8230879 ↗
• InjuryNov 22, 2018Loose or Intermittent Connection

  REVISION SURGERY PERFORMED 6 YEARS AFTER PRIMARY DUE TO STEM LOOSENING. STEM AND HEAD WERE REVISED, SURGERY COMPLETED SUCCESSFULLY.

  Patient problems: Joint Disorder

  MAUDE report 8098806 ↗
• InjuryJul 13, 2018Loose or Intermittent Connection

  REVISION SURGERY 6 YEARS AFTER PRIMARY DUE TO STEM LOOSENED OVER TIME: THE SIZE 1 LAT QUADRA-H WAS REVISED WITH A SIZE 3 QUADRA-H LAT. THIS REVISION WAS NOT DUE TO ANY ISSUES WITH THE IMPLANT ITSELF. THE OUTCOME OF THE CASE WAS POSITIVE.

  Patient problems: Joint Disorder

  MAUDE report 7685639 ↗
• InjuryMar 29, 2018Device Slipped

  REVISION SURGERY PERFORMED DUE TO STEM LOOSENING. QUADRA-H WAS REPLACED WITH A QUADRA-C.

  Patient problems: Joint Disorder

  MAUDE report 7380961 ↗
• InjuryFeb 2, 2018Loose or Intermittent Connection

  ONE YEAR AND 1 MONTH AFTER PRIMARY THE PATIENT WAS REVISED FOR A STEM LOOSENING. THE STEM WAS SWAPPED SUCCESSFULLY.

  Patient problems: Joint Disorder

  MAUDE report 7237241 ↗

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