Quadra P femoral stems 01.12.211Recalls & reported problems
Medacta International SA · Quadra-P Cemented STD stem #1 · Class 2 · Implant
All models of Quadra P femoral stems (27)
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 3
- Deaths reported
- 0
- Injuries reported
- 3
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 07630040732086), received between Oct 26, 2023 and May 29, 2026 — classified as 3 injuries.
The most frequently reported specific device problem is “Device Appears to Trigger Rejection” (1 report).
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.
Reports received per month
Most reported problems
Device problems
- Device Appears to Trigger Rejection1
- Loosening of Implant Not Related to Bone-Ingrowth1
- Migration1
Patient problems
- Implant Pain2
- Medical device site infection1
Recent adverse event reports
The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.
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 ↗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 ↗InjuryOct 26, 2023Loosening of Implant Not Related to Bone-Ingrowth; Loosening of Implant Not Related to Bone-Ingrowth
AT ABOUT 1 YEAR AND 9 MONTHS FROM THE PRIMARY, THE PATIENT CAME IN REPORTING PAIN DUE TO A LOOSE STEM AND THE CAUSE OF THE LOOSE STEM IS UNKNOWN. THE SURGEON REVISED THE STEM AND HEAD AND THE SURGERY WAS COMPLETED SUCCESSFULLY.
Patient problems: Implant Pain
MAUDE report 18011655 ↗
Other Prosthesis, Hip, Hemi-, Femoral, Metal Ball devices
- NA 1363-10-000Depuy Orthopaedics, Inc. · Prosthesis, hip, hemi-, femoral, metal ball117 reports
- NA 1363-08-000Depuy Orthopaedics, Inc. · Prosthesis, hip, hemi-, femoral, metal ball66 reports
- NA 1363-12-000Depuy Orthopaedics, Inc. · Prosthesis, hip, hemi-, femoral, metal ball44 reports
- NA 1363-46-000Depuy Orthopaedics, Inc. · Prosthesis, hip, hemi-, femoral, metal ball39 reports
- NA 1363-47-000Depuy Orthopaedics, Inc. · Prosthesis, hip, hemi-, femoral, metal ball34 reports
- NA 1363-45-000Depuy Orthopaedics, Inc. · Prosthesis, hip, hemi-, femoral, metal ball31 reports
- NA 1363-44-000Depuy Orthopaedics, Inc. · Prosthesis, hip, hemi-, femoral, metal ball25 reports
- NA 1363-49-000Depuy Orthopaedics, Inc. · Prosthesis, hip, hemi-, femoral, metal ball23 reports
Sources and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026 · each report above links to its original FDA record
- 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.
How reports and recalls are matched · Editorial policy · Report an error on this page