Quadra H femoral stems 01.12.023Recalls & reported problems

Summary

The FDA's MAUDE database contains 32 adverse event reports that list this exact device (DI 07630030802041), received between Jul 19, 2017 and Apr 30, 2026 — classified as 30 injuries, 2 malfunctions.

The most frequently reported specific device problem is “Loose or Intermittent Connection” (7 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 32 reports, in the reporter's own words as published by the FDA.

• InjuryApr 30, 2026Osseointegration Problem

  REVISION SURGERY DUE TO STEM LOOSENING AFTER ABOUT 18 YEARS AND 3 MONTHS FROM PRIMARY SURGERY.

  Patient problems: Aseptic loosening

  MAUDE report 25040715 ↗
• InjuryMar 18, 2026Osseointegration Problem

  AT ABOUT 16 YEARS AND1 MONTHFROM THE PRIMARY, THE PATIENT CAME IN REPORTING PAIN AND THE CAUSE WAS DUE TO A LOOSE STEM ANDACETABULAR CUP. THE SURGEON REVIEWED THE BONE SCAN AND VERIFIED THE LOOSE IMPLANT AND DETERMINED THAT A TOTAL HIP REVISION WAS NECESSARY. THE SURGEON REVISED THE QUADRA STANDARD STEM TO A QUADRA-P COLLARED STEM, THE 28MM BIOLOX HEAD TO A 40MM BIOLOX HEAD M, THE VERSAFITCUP DM 52MM TO A MPACT D 54 CUP, AND THE VERSAFITCUP LINER 52MM X 28 TO A D 40/F MPACT LINER. THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: Aseptic loosening; Inadequate Osseointegration

  MAUDE report 24631234 ↗
• InjuryFeb 18, 2026Fracture

  ON (B)(6) 2026 TWO SURGEONS UNDERTOOK THEIR FIRST AMIS LIST WITH A PROCTORING CONSULTANT PRESENT TO SUPPORT. AN MPACT CUP AND QUADRA H STEM WERE INSERTED THROUGH THE ANTERIOR APPROACH USING THE AMIS LEG POSITIONER. ON TABLE X-RAYS LOOKED FINE, WITH THE FINAL IMAGE BEING TAKEN WITH THE DEFINITIVE IMPLANTS INSITU IMMEDIATELY PRIOR TO CLOSURE. NO SIGNS OF FRACTURE ARE VISIBLE ON ANY XRAY TAKEN DURING THE CASE. LATER THAT EVENING THE PATIENT WAS TAKEN FOR A POST OP X-RAY WHICH IDENTIFIED A VANCOUVER B1 PERIPROSTHETIC FRACTURE. A CT SCAN LATER SHOWED NO FRACTURE IN THE CALCAR. RE-OPERATION TO FIX THE FRACTURE WITH AN THE FOLLOWING DAY, STEM NOT REVISED.

  Patient problems: Bone Fracture(s)

  MAUDE report 24376305 ↗
• InjuryNov 18, 2025Loss of Osseointegration; Loss of Osseointegration

  AT ABOUT 9 YEARS FROM PRIMARY REVISION SURGERY DUE TO ASEPTING STEM LOOSENING. STEM, HEAD AND LINER REVISED.

  Patient problems: Aseptic loosening

  MAUDE report 23579959 ↗
• InjurySep 18, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  AT ABOUT 3 YEARS AND 11 MONTHS FROM PRIMARY THE PATIENT UNDERWENT REVISION DUE TO A LOOSE STEM. SURGEON REVISED THE STEM TO A X-ACTA STEM AND SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: Aseptic loosening

  MAUDE report 23081974 ↗
• InjuryApr 1, 2025Failure to Osseointegrate; Failure to Osseointegrate

  AT ABOUT 5 YEARS AND 3 MONTHS FROM PRIMARY, THE PATIENT UNDERWENT REVISION SURGERY DUE TO THIGH PAIN, RADIOLUCENT LINER IN CONTROL X-RAY, AND STEM LOOSENING. THE SURGEON REPLACED THE STEM WITH A CEMENTED ONE. SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: Inadequate Osseointegration

  MAUDE report 21737436 ↗
• MalfunctionMar 19, 2025Osseointegration Problem; Osseointegration Problem

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

  Patient problems: Inadequate Osseointegration; Pain

  MAUDE report 21640392 ↗
• InjuryJan 24, 2025Fracture; Fracture

  PRIMARY HIP SURGERY PERFORMED ON (B)(6) 2020. REVISION SURGERY WAS PERFORMED DUE TO STEM FRACTURE ABOUT 4 YEARS AND A HALF AFTER THE PRIMARY SURGERY. ACCORDING TO THE INFORMATION RECEIVED, THE PROSTHETIC FEMORAL COMPONENT OF THE KNEE WAS CONNECTED TO THE STEM (MEGAPROSTHESIS WITH COMPETITOR'S COMPONENTS) ON (B)(6) 2022, AND THIS IS THE REASON FOR THE BREAKAGE.

  Patient problems: Insufficient Information

  MAUDE report 21228580 ↗
• InjuryJan 11, 2023Failure to Osseointegrate; Failure to Osseointegrate

  REVISION SURGERY PERFORMED AT ABOUT 1 YEAR AND 10 MONTHS AFTER THE PRIMARY DUE TO INSUFFICIENT OSSEOINTEGRATION OF THE PROXIMAL STEM WITH INTRA-OPERATIVE SCAR TISSUE THAT FORMED AROUND THE STEM. OSTEOLYSIS WAS OBSERVED. THE SURGERY WAS COMPLETED SUCCESSFULLY REVISING STEM AND HEAD.

  Patient problems: Inadequate Osseointegration

  MAUDE report 16136737 ↗
• InjuryDec 22, 2022Osseointegration Problem; Osseointegration Problem

  AT ABOUT 14 YEARS AND 6 MONTHS AFTER THE PRIMARY SURGERY, THE PATIENT WAS REVISED DUE TO ASEPTIC LOOSENING OF THE STEM. THE SURGERY WAS COMPLETED SUCCESSFULLY BY REVISING STEM, HEAD AND LINER.

  Patient problems: Inadequate Osseointegration

  MAUDE report 16032296 ↗
• InjuryNov 4, 2022Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available

  REVISION SURGERY PERFORMED 2 DAYS AFTER THE PRIMARY SURGERY DUE TO A PERIPROSTHETIC FRACTURE, FOR REASONS UNKNOWN. STEM AND HEAD HAVE BEEN REVISED. SALES REP COMMENT: THE STEM WAS UNDERSIZED. A SIZE 2 WAS PLANNED, AND THEN A SIZE 3 HAS BEEN IMPLANTED. BUT EVEN A SIZE 4 WOULD HAVE BEEN UNDERSIZED.

  Patient problems: Bone Fracture(s)

  MAUDE report 15734901 ↗
• InjuryJun 9, 2022Fracture; Appropriate Device Problem Term/Code Not Available

  ON (B)(6) 2022, THE PRIMARY SURGERY WAS PERFORMED. AFTER A PERIPROSTHETIC FRACTURE, THE STEM, THE LINER, AND THE HEAD WERE REVISED ON (B)(6) 2022. PRESENTLY, (B)(6) 2022, REVISION TOOK PLACE IN (B)(6) FOLLOWING INFECTION. THE SURGEON REVISED SUCCESSFULLY THE LINER AND HEAD.

  Patient problems: Bone Fracture(s); Unspecified Infection

  MAUDE report 14641437 ↗
• InjuryJun 2, 2022Osseointegration Problem; Osseointegration Problem

  REVISION SURGERY FOLLOWING SUSPECTED LINER WEAR AND STEM LOOSENING 14 YEARS AND 4 MONTHS AFTER PRIMARY.

  Patient problems: Insufficient Information

  MAUDE report 14571958 ↗
• InjuryAug 25, 2021Adverse Event Without Identified Device or Use Problem

  THE PATIENT CAME IN FOR A POST-OP APPOINTMENT AND THE X-RAYS REVEALED THAT THERE OSTEOLYSIS AROUND THE FEMUR. THE CAUSE OF THE OSTEOLYSIS IS UNKNOWN. 11 YEARS AND 6 MONTHS AFTER THE PRIMARY SURGERY, THE SURGEON PUT BONE GRAFT AROUND THE FEMUR AND REVISED THE HEAD AND LINER. THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: Osteolysis

  MAUDE report 12364714 ↗
• InjuryApr 7, 2021Failure to Align

  REVISION SURGERY PERFORMED 9 YEARS AND 2 MONTHS AFTER THE PRIMARY SURGERY DUE TO STEM MOBILIZATION.

  Patient problems: Insufficient Information

  MAUDE report 11626622 ↗
• InjuryFeb 25, 2021Loosening of Implant Not Related to Bone-Ingrowth

  STEM REVISED 8 YEARS AFTER PRIMARY DUE TO ASEPTIC LOOSENING. PRIMARY SURGERY WAS IN 2013, EXACT DATE IS UNKNOWN. ALSO CERAMIC LINER, CERAMIC HEAD AND CUP HAVE BEEN REVISED (REF AND LOTS UNKNOWN).

  Patient problems: Inadequate Osseointegration

  MAUDE report 11377941 ↗
• InjuryNov 30, 2020Loose or Intermittent Connection

  REVISION SURGERY 4 YEARS AND 3 MONTHS AFTER SURGERY FOR STEM LOOSENING. THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: Insufficient Information

  MAUDE report 10918065 ↗
• InjuryNov 19, 2020Loose or Intermittent Connection; Difficult to Remove

  REVISION SURGERY PERFORMED AFTER 7 YEARS AND 7 MONTHS DUE TO SUBSIDENCE OF STEM. THE STEM AND HEAD WERE REVISED AND A COMPETITOR STEM WAS CEMENTED IN. THERE WAS CONSIDERABLE DIFFICULTY REMOVING THE SIZE 3 STANDARD OFFSET QUADRA STEM THAT REQUIRED AN ETO (EXTENDED TROCHANTERIC OSTEOTOMY) AND SUBSEQUENT CABLES.

  Patient problems: Insufficient Information

  MAUDE report 10867719 ↗
• InjurySep 28, 2020Appropriate Device Problem Term/Code Not Available

  1 YEAR AND 2 MONTHS AFTER PRIMARY, REVISION SURGERY PERFORMED DUE TO INFECTION. RIGHT SIDE. THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: Unspecified Infection

  MAUDE report 10593620 ↗
• InjurySep 28, 2020Fracture

  REVISION SURGERY PERFORMED DUE TO PERI-PROSTHETIC FRACTURE OF THE BONE 12 DAYS AFTER PRIMARY. LEFT SIDE.

  Patient problems: Insufficient Information

  MAUDE report 10593618 ↗
• InjuryJul 10, 2020Adverse Event Without Identified Device or Use Problem

  2ND INFECTION OF THR REQUIRING REVISION SURGERY TO REMOVE ALL IMPLANTS AFTER 2 YEARS AND 5 MONTHS FROM THE PRIMARY SURGERY. THE FIRST INFECTION AND REVISION OF HEAD AND LINER WAS DONE IN (B)(6) 2018.

  Patient problems: Unspecified Infection

  MAUDE report 10257289 ↗
• InjuryJun 12, 2020Loosening of Implant Not Related to Bone-Ingrowth

  REVISION SURGERY PERFORMED, 6 YEARS AND 10 MONTHS AFTER PRIMARY SURGERY, DUE TO STEM LOOSENING. FEMORAL COMPONENTS AND LINER WERE SUCCESSFULLY REVISED.

  Patient problems: No Code Available

  MAUDE report 10147518 ↗
• InjuryMay 27, 2020Loose or Intermittent Connection

  ABOUT 2 YEARS AFTER PRIMARY THE SURGEON PLANNED TO REVISE THE PATIENT STEM FOR LOOSENING. SURGERY PLANNED ON THE (B)(6) 2020.

  Patient problems: Joint Disorder

  MAUDE report 10091678 ↗
• InjuryMar 30, 2020Loosening of Implant Not Related to Bone-Ingrowth; Loosening of Implant Not Related to Bone-Ingrowth

  REVISION SURGERY PERFORMED 3 YEARS AND 1 MONTH AFTER THE PRIMARY SURGERY DUE TO THE PROXIMAL LOOSENING OF A QUADRA H STEM. THE SURGEON REVISED THE STEM AND BALL HEAD. THE PATIENT WAS A HEAVY WORKING FARMER.

  Patient problems: Failure of Implant

  MAUDE report 9896985 ↗
• InjuryJan 31, 2020Appropriate Device Problem Term/Code Not Available

  REVISION SURGERY PERFORMED AFTER 9 MONTHS FROM THE LAST REVISION SURGERY DUE TO AN INFECTION. THE SURGEON REVISED THE STEM AND THE HEAD. DURING PREVIOUS SURGERIES THE SURGEON PERFORMED ONLY WASHOUTS DUE TO AN INFECTION.

  Patient problems: Unspecified Infection

  MAUDE report 9652064 ↗

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