Quadra P femoral stemsRecalls & reported problems across all models
Medacta International SA · 27 models in the FDA device registry
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 55
- Deaths reported
- 0
- Injuries reported
- 54
- Recalls
- 0
We found 27 models of Quadra P femoral stems by Medacta International SA in the FDA's device registry (GUDID). Together they are named in 55 adverse event reports in the FDA's MAUDE database, received between Feb 4, 2020 and Sep 9, 2026 — classified as 54 injuries, 1 malfunction.
The most frequently reported specific device problem is “Device Appears to Trigger Rejection” (15 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 P femoral stems problems
Device problems
- Device Appears to Trigger Rejection15
- Migration8
- Loss of Osseointegration7
- Adverse Event Without Identified Device or Use Problem6
- Appropriate Device Problem Term/Code Not Available5
- Fracture4
- Implant subsidence3
- Osseointegration Problem3
Patient problems
- Medical device site infection11
- Bone Fracture(s)10
- Inadequate Osseointegration6
- Unspecified Infection6
- Implant Pain5
- No Clinical Signs, Symptoms or Conditions5
- Pain4
- Aseptic loosening2
Quadra P femoral stems models
27 models, most reported first. Each model has its own page with its reports, recalls and device details.
- Quadra P femoral stems 01.12.122Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented5 reports
- Quadra P femoral stems 01.12.123Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented4 reports
- Quadra P femoral stems 01.12.144Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented4 reports
- Quadra P femoral stems 01.12.121Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented3 reports
- Quadra P femoral stems 01.12.126Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented3 reports
- Quadra P femoral stems 01.12.142Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented3 reports
- Quadra P femoral stems 01.12.161Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented3 reports
- Quadra P femoral stems 01.12.211Prosthesis, Hip, Hemi-, Femoral, Metal Ball3 reports
- Quadra P femoral stems 01.12.143Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented2 reports
- Quadra P femoral stems 01.12.147Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented2 reports
- Quadra P femoral stems 01.12.164Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented2 reports
- Quadra P femoral stems 01.12.165Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented2 reports
- Quadra P femoral stems 01.12.182Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented2 reports
- Quadra P femoral stems 01.12.212Prosthesis, Hip, Hemi-, Femoral, Metal Ball2 reports
- Quadra P femoral stems 01.12.251Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented2 reports
- Quadra P femoral stems 01.12.252Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented2 reports
- Quadra P femoral stems 01.12.120Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented1 report
- Quadra P femoral stems 01.12.125Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented1 report
- Quadra P femoral stems 01.12.141Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented1 report
- Quadra P femoral stems 01.12.145Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented1 report
- Quadra P femoral stems 01.12.159Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented1 report
- Quadra P femoral stems 01.12.160Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented1 report
- Quadra P femoral stems 01.12.163Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented1 report
- Quadra P femoral stems 01.12.188Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented1 report
- Quadra P femoral stems 01.12.253Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented1 report
- Quadra P femoral stems 01.12.272Prosthesis, Hip, Hemi-, Femoral, Metal Ball1 report
- Quadra P femoral stems 01.12.273Prosthesis, Hip, Hemi-, Femoral, Metal Ball1 report
Recent Quadra P 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 9, 2026Device Appears to Trigger Rejection
On (b)(6) 2022, the patient had primary surgery. On (b)(6) 2026, the patient came in due to infection and the pathogen is unknown. The surgeon performed a washout, revised the 28mm Biolox Head S to a same size head and revised the D 28/DMI HC liner to a same size liner. The surgery was completed successfully. Presently, on (b)(4) 2026, the patient came in due to signs of infection and the pathogen is unknown. The surgeon performed a washout, I&D, and revised all implants to antibiotic spacers. The surgery was completed successfully.
Patient problems: Medical device site infection
MAUDE report 50692295 ↗InjurySep 9, 2026Device Appears to Trigger Rejection
At about 12 days after the primary surgery, revision surgery was performed due to infection. The initial indication for revision was instability; however, intraoperatively, an infection was identified, resulting in the removal of all implants. All implants were successfully removed.
Patient problems: Medical device site infection
MAUDE report 50692283 ↗InjuryMay 29, 2026Migration
THE PATIENT HAD PRIMARY SURGERY USING COMPETITOR PRODUCTS. ON (B)(6) 2026, THE PATIENT`S COMPETITOR STEM WAS REVISED TO A QUADRA-P CEMENTED STD. SIZE5 AND A 32MM BIOLOX DELTA HEAD M. ON (B)(6) 2026, THE PATIENT CAME IN PRESENTING PAIN DUE TO A SUBSIDED STEM AS THE RESULT OF THE CEMENT NOT ADHERING TO THE PATIENT`S BONE. THE SURGEON REVISED THE STEM TO DISTAL STEM D 20MM L 140MM STRAIGHT AND REVISED THE HEAD TO A SAME SIZE HEAD. THE SURGERY AS COMPLETED SUCCESSFULLY.
Patient problems: Implant Pain
MAUDE report 25328459 ↗InjuryMay 27, 2026Device Appears to Trigger Rejection
THE PATIENT HAD A HIP INFECTION AND THE PATHOGEN IS UNKNOWN. ABOUT 20 DAYS AFTER PRIMARY THE SURGEON PERFORMED WASHOUT AND REVISED THE QUADRA-P COLLARED STD. SIZE 1 STEM TO A M-FINITY COLLARED SIZE 5 STEM, REVISED THE D 28/DMD HC LINER WITH A D 36/E FLAT PE HC LINER, REVISED THE VERSAFITCUP METALBACK DM D 48MM TO AN MPACT D 50 MULTI-HOLE CUP, AND REVISED THE 28MM BIOLOX OPTION HEAD WITH SLEEVE TO A 36MM BIOLOX OPTION HEAD WITH SLEEVE. THE SURGERY WAS COMPLETED SUCCESSFULLY.
Patient problems: Medical device site infection
MAUDE report 25297694 ↗InjuryMay 12, 2026Migration
THE PATIENT HAD PAIN DUE TO A SUBSIDED STEM AND THE CAUSE IS UNKNOWN. THERE WERE NO REPORTS OF TRAUMA OR BONE QUALITY ISSUES. AT ABOUT 3 YEARS FROM THE PRIMARY SURGERY, THE SURGEON REVISED THE D 28/DMF LINER TO A SAME SIZE LINER, AND THE 28MM BIOLOX HEAD S TO A 28MM BIOLOX OPTION HEAD WITH XL OPTION SLEEVE. THE SURGERY WAS COMPLETED SUCCESSFULLY.
Patient problems: Implant Pain
MAUDE report 25148936 ↗InjuryApr 23, 2026Device Appears to Trigger Rejection
REVISION SURGERY DUE TO INFECTION AFTER 21 DAYS FROM PRIMARY SURGERY AND THE CAUSE IS UNKNOWN. THE SURGEON PERFORMED A WASHOUT AND REVISED ALL HIP COMPONENTS TO ANTIBIOTIC SPACERS FOR A STAGE ONE REVISION. THE SURGERY WAS COMPLETED SUCCESSFULLY.
Patient problems: Medical device site infection
MAUDE report 24964779 ↗InjuryApr 20, 2026Implant subsidence
AT ABOUT 1 MONTH AND HALF AFTER THE PRIMARY, THE PATIENT CAME IN PRESENTING PAIN AS THE RESULT OF A SUBSIDED STEM AND THE CAUSE IS UNKNOWN. THERE WAS NO INDICATION OF TRAUMA. THE SURGEON REVISED THE STEM (SIZE 3 TO 5), THE HEAD AND LINER (SAME SIZE). THE SURGERY WAS COMPLETED SUCCESSFULLY.
Patient problems: Implant Pain
MAUDE report 24924650 ↗InjuryMar 24, 2026Adverse Event Without Identified Device or Use Problem
AT ABOUT 3 WEEKS FROM THE PRIMARY, THE PATIENT CAME IN PRESENTING HIP PAIN DUE TO A FRACTURE OF THE LESSER TROCHANTER AND CALCAR BONE LOSS. THERE WERE NO INDICATIONS OF TRAUMA. THE SURGEON REVISED THE QUADRA P SIZE4 STEM TO A QUADRA R SIZE 4 STEM AND THE BIOLOX 40MM HEAD M TO A BIOLOX 40MM HEAD S. THE SURGERY WAS COMPLETED SUCCESSFULLY.
Patient problems: Bone Fracture(s)
MAUDE report 24681022 ↗InjuryMar 10, 2026Osseointegration Problem
AT ABOUT 1 YEAR 11 MONTHS AFTER THE PRIMARY, THE PATIENT CAME IN PRESENTING PAIN DUE TO A LOOSE STEM AND THE CAUSE IS UNKNOWN. THERE ARE NO INDICATIONS OF TRAUMA. THE SURGEON REVISED THE STEM AND HEAD TO COMPETITOR IMPLANTS, AND REVISED THE LINER TO SAME SIZE MEDACTA LINER. THE SURGERY WAS COMPLETED SUCCESSFULLY.
Patient problems: Aseptic loosening
MAUDE report 24558210 ↗InjuryFeb 24, 2026Device Appears to Trigger Rejection
REVISION SURGERY WAS PERFORMED 1 YEAR AND 2 MONTHS AFTER THE PRIMARY PROCEDURE DUE TO INFECTION. THE PATHOGEN WAS UNKNOWN. THE SURGERY WAS COMPLETED SUCCESSFULLY.
Patient problems: Medical device site infection
MAUDE report 24429839 ↗MalfunctionJan 8, 2026Implant subsidence
AT ABOUT 2 MONTHS FROM PRIMARY, THE PATIENT CAME IN REPORTING PAIN. ORIGIN OF THE PAIN WAS IDENTIFIED IN A FRACTURE OF THE FEMUR CAUSED BY STEM SUBSIDENCE. CURRENTLY, THE SURGEON DOES NOT PLAN TO PERFORM A REVISION SURGERY AS STEM SEEMS STABLE AND FRACTURE SHOULD HEAL ON ITS OWN. WALKER AND CONSERVATIVE WEIGHT BEARING PRESCRIBED.
Patient problems: Bone Fracture(s)
MAUDE report 24004374 ↗InjuryDec 9, 2025Device Appears to Trigger Rejection; Device Appears to Trigger Rejection
AT ABOUT 10 MONTHS FROM THE PRIMARY, THE PATIENT CAME IN DUE TO SIGNS OF AN INFECTION AND THE PATHOGEN IS UNKNOWN. THE SURGEON PERFORMED A WASHOUT, REMOVED ALL IMPLANTS, AND IMPLANTED NEW HARDWARE. THE SURGERY WAS COMPLETED SUCCESSFULLY.
Patient problems: Medical device site infection
MAUDE report 23758555 ↗InjuryNov 18, 2025Implant subsidence; Implant subsidence
AT ABOUT 7 MONTHS AFTER THE PRIMARY, THE PATIENT CAME IN REPORTING PAIN DUE TO A SUBSIDED STEM AND THE CAUSE IS UNKNOWN. THE SURGEON REVISED THE MEDACTA DOUBLE MOBILITY LINER WITH A NEW ONE AND REVISED THE STEM AND HEADWITH COMPETITOR PRODUCTS. THE SURGERY WAS COMPLETED SUCCESSFULLY.
Patient problems: Implant Pain
MAUDE report 23579654 ↗InjuryAug 14, 2025Loss of Osseointegration; Loss of Osseointegration
THE PATIENT HAD HIP PAIN AND THE SURGEON DETERMINED THE CAUSE WAS LOOSENING AROUND THE LATERAL SHOULDER OF THE IMPLANT AND THE CAUSE IS UNKNOWN. AT ABOUT 8 MONTHS POST PRIMARY THE SURGEON REVISED THE STEM, HEAD AND LINER. THE SURGERY WAS COMPLETED SUCCESSFULLY.
Patient problems: Aseptic loosening
MAUDE report 22803543 ↗InjuryApr 4, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
AT ABOUT 1 YEAR AFTER PRIMARY, THE PATIENT CAME IN REPORTING PAIN DUE TO A FRACTURED FEMORAL BONE AND THE CAUSE IS UNKNOWN. THE SURGEON REVISED THE FEMORAL HEAD AND BIPOLAR HEAD. THE SURGERY WAS COMPLETED SUCCESSFULLY.
Patient problems: Bone Fracture(s)
MAUDE report 21771467 ↗
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
- Quadra H femoral stems32 models · 354 reports
- MectaLIF Anterior6 models · 4 reports · 6 recalls
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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