Quadra H femoral stemsRecalls & reported problems across all models
Medacta International SA · 32 models in the FDA device registry
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 354
- Deaths reported
- 0
- Injuries reported
- 340
- Recalls
- 0
We found 32 models of Quadra H femoral stems by Medacta International SA in the FDA's device registry (GUDID). Together they are named in 354 adverse event reports in the FDA's MAUDE database, received between Jun 27, 2017 and Sep 1, 2026 — classified as 340 injuries, 14 malfunctions.
The most frequently reported specific device problem is “Loose or Intermittent Connection” (88 reports).
Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event. Widely used products collect more reports, so totals can't be used to compare products or estimate failure rates. Only reports that name a model's exact device identifier are counted. What reports can and can't tell you · How this data works
Reports received per month, all models
Most reported Quadra H femoral stems problems
Device problems
- Loose or Intermittent Connection88
- Osseointegration Problem72
- Appropriate Device Problem Term/Code Not Available67
- Loosening of Implant Not Related to Bone-Ingrowth34
- Fracture19
- Adverse Event Without Identified Device or Use Problem16
- Failure to Osseointegrate16
- Device Slipped14
Patient problems
- Inadequate Osseointegration110
- Joint Disorder69
- Pain35
- Unspecified Infection28
- Insufficient Information25
- Aseptic loosening24
- Bone Fracture(s)22
- Implant Pain12
Quadra H femoral stems models
32 models, most reported first. Each model has its own page with its reports, recalls and device details.
- Quadra H femoral stems 01.12.023Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Cemented32 reports
- Quadra H femoral stems 01.12.021Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Cemented26 reports
- Quadra H femoral stems 01.12.022Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Cemented26 reports
- Quadra H femoral stems 01.12.024Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Cemented25 reports
- Quadra H femoral stems 01.12.032Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Cemented23 reports
- Quadra H femoral stems 01.12.033Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Cemented20 reports
- Quadra H femoral stems 01.12.23SNProsthesis, Hip, Semi-Constrained, Metal/Polymer, Cemented20 reports
- Quadra H femoral stems 01.12.21SNProsthesis, Hip, Semi-Constrained, Metal/Polymer, Cemented18 reports
- Quadra H femoral stems 01.12.22SNProsthesis, Hip, Semi-Constrained, Metal/Polymer, Cemented17 reports
- Quadra H femoral stems 01.12.025Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Cemented16 reports
- Quadra H femoral stems 01.12.031Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Cemented15 reports
- Quadra H femoral stems 01.12.035Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Cemented14 reports
- Quadra H femoral stems 01.12.20SNProsthesis, Hip, Semi-Constrained, Metal/Polymer, Cemented13 reports
- Quadra H femoral stems 01.12.026Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Cemented12 reports
- Quadra H femoral stems 01.12.034Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Cemented11 reports
- Quadra H femoral stems 01.12.020Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Cemented8 reports
- Quadra H femoral stems 01.12.027Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Cemented7 reports
- Quadra H femoral stems 01.12.036Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Cemented6 reports
- Quadra H femoral stems 01.12.31SNProsthesis, Hip, Semi-Constrained, Metal/Polymer, Cemented6 reports
- Quadra H femoral stems 01.12.33SNProsthesis, Hip, Semi-Constrained, Metal/Polymer, Cemented6 reports
- Quadra H femoral stems 01.12.028Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Cemented5 reports
- Quadra H femoral stems 01.12.32SNProsthesis, Hip, Semi-Constrained, Metal/Polymer, Cemented5 reports
- Quadra H femoral stems 01.12.34SNProsthesis, Hip, Semi-Constrained, Uncemented, Metal/Polymer, Non-Porous, Calicum-Phosphate5 reports
- Quadra H femoral stems 01.12.037Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Cemented3 reports
- Quadra H femoral stems 01.12.24SNProsthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented3 reports
- Quadra H femoral stems 01.12.25SNProsthesis, Hip, Semi-Constrained, Uncemented, Metal/Polymer, Non-Porous, Calicum-Phosphate3 reports
- Quadra H femoral stems 01.12.35SNProsthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented3 reports
- Quadra H femoral stems 01.12.98SNProsthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented2 reports
- Quadra H femoral stems 01.12.26SNProsthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented1 report
- Quadra H femoral stems 01.12.27SNProsthesis, Hip, Semi-Constrained, Uncemented, Metal/Polymer, Non-Porous, Calicum-Phosphate1 report
- Quadra H femoral stems 01.12.36SNProsthesis, Hip, Semi-Constrained, Uncemented, Metal/Polymer, Non-Porous, Calicum-Phosphate1 report
- Quadra H femoral stems 01.12.37SNProsthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented1 report
Recent Quadra H femoral stems adverse event reports
The 15 most recent reports across all models, in the reporter's own words as published by the FDA.
InjurySep 1, 2026Osseointegration Problem
Patient problems: Aseptic loosening; Inadequate Osseointegration
MAUDE report 50543257 ↗InjurySep 1, 2026Osseointegration Problem
Patient problems: Aseptic loosening; Implant Pain
MAUDE report 50543230 ↗InjuryAug 27, 2026Osseointegration Problem
Revision surgery performed due to stem loosening about 1 year and 2 months after the primary surgery.
Patient problems: Aseptic loosening
MAUDE report 50474969 ↗InjuryJul 6, 2026Osseointegration Problem
PRIMARY HIP SURGERY WAS PERFORMED ON (B)(6) 2022. APPROXIMATELY ONE YEAR BEFORE THE REVISION SURGERY, THE PATIENT REPORTED THE ONSET OF MID-THIGH PAIN AND INITIALLY CONSULTED THEIR LOCAL DOCTOR, RECEIVING PAIN MANAGEMENT AND PHYSIOTHERAPY BEFORE BEING REVIEWED BY AN ORTHOPAEDIC CONSULTANT. DURING THE CLINICAL INVESTIGATION, THE REVISION SURGEON NOTED PROXIMAL LOOSENING ON X-RAY, REFERRING TO THE FEMORAL STEM. BASED ON THESE FINDINGS, THE SURGEON DECIDED TO REMOVE THE STEM AND CHANGE THE CUP SIZE, AS THE PATIENT WAS CONSIDERED TO BE AT INCREASED RISK OF DISLOCATION DUE TO OBESITY. REVISION SURGERY WAS PERFORMED ON (B)(6) 2026, DURING WHICH ALL IMPLANTS WERE REPLACED WITH COMPETITOR DEVICES ACCORDING TO THE SURGEON`S PREFERENCE, WITH IMPLANTATION OF A SIZE 50 COMPETITOR DUAL MOBILITY CUP.
Patient problems: Aseptic loosening; Implant Pain; Inadequate Osseointegration
MAUDE report 25714731 ↗InjuryJun 17, 2026Implant subsidence
REVISION SURGERY WAS PERFORMED ABOUT 8 YEARS AND 9 MONTHS AFTER THE PRIMARY SURGERY FOLLOWING A TRAUMATIC LEFT PROXIMAL FEMORAL FRACTURE, SUBSEQUENT HIP DISLOCATION, AND FURTHER STEM SUBSIDENCE/LOOSENING/RETROVERSION. ACCORDING TO THE REVISION SURGEON, SIGNS OF STEM SUBSIDENCE WERE ALREADY PRESENT PRIOR TO THE TRAUMA. ALL COMPONENTS WERE REVISED TO A COMPETITOR SYSTEM.
Patient problems: Implant Pain
MAUDE report 25528761 ↗InjuryJun 17, 2026Osseointegration Problem
REVISION SURGERY DUE TO STEM LOOSENING AFTER ABOUT 7 YEARS AND 7 MONTHS FROM PRIMARY. STEM, HEAD AND LINER REVISED.
Patient problems: Aseptic loosening
MAUDE report 25528750 ↗InjuryMay 15, 2026Osseointegration Problem
AT ABOUT 8 MONTHS FROM THE PRIMARY, THE PATIENT CAME IN PRESENTING PAIN DUE TO A CONFIRMED LOOSE STEM AND THE CAUSE IS UNKNOWN. THERE WERE NO INDICATIONS OF TRAUMA. THE SURGEON REVISED THE MEDACTA STEM AND HEAD TO A COMPETITOR STEM AND HEAD AND REVISED THE MEDACTA FLAT PE HC LINER D 36/E TO A MEDACTA DOUBLE MOBILITY HC LINER D 28/DMC AND CONVERTER. THE SURGERY WAS COMPLETED SUCCESSFULLY.
Patient problems: Aseptic loosening; Inadequate Osseointegration
MAUDE report 25185337 ↗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 ↗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 ↗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 ↗InjuryApr 28, 2026Osseointegration Problem
REVISION SURGERY DUE TO STEM LOOSENING ABOUT 8 YEARS AND 3 MONTHS AFTER PRIMARY SURGERY. THERE WAS NO INDICATION OF TRAUMA. THE SURGEON MADE NO NOTE OF BONE QUALITY. THE SURGEON REVISED THE MEDACTA STEM AND HEAD TO A COMPETITOR STEM AND HEAD, AND REVISED THE MEDACTA LINER TO A SAME SIZE LINER. THE SURGERY WAS COMPLETED SUCCESSFULLY.
Patient problems: Aseptic loosening
MAUDE report 25012258 ↗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 ↗InjuryApr 9, 2026Osseointegration Problem
REVISION SURGERY PERFORMED ABOUT 8 YEARS AND 10 MONTHS AFTER THE PRIMARY SURGERY DUE TO STEM ASEPTIC LOOSENING. NO INFECTION IDENTIFIED AND NO TRAUMA REPORTED.
Patient problems: Aseptic loosening
MAUDE report 24826105 ↗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 ↗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 ↗
Other Medacta International SA products
- GMK Sphere Total Knee System209 models · 2,306 reports
- GMK Primary Total Knee System99 models · 876 reports
- Shoulder System63 models · 716 reports
- AMIStem H Femoral Stems20 models · 679 reports
- Mpact Acetabular System68 models · 609 reports
- Mectacer Biolox Delta Femoral Ball Head15 models · 551 reports
- MectaLIF Anterior6 models · 4 reports · 6 recalls
- GMK Revision Total Knee System71 models · 304 reports
Sources and updates
- Models: FDA GUDID, file dated Oct 13, 2026. Models are grouped by the brand name the manufacturer registered.
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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