Quadra P femoral stems 01.12.123Recalls & reported problems
Medacta International SA · Quadra-P Std. #3 · 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
- 4
- Deaths reported
- 0
- Injuries reported
- 4
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 07630040720441), received between Aug 30, 2023 and Sep 9, 2026 — classified as 4 injuries.
The most frequently reported specific device problem is “Device Appears to Trigger Rejection” (2 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, 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 Rejection2
- Adverse Event Without Identified Device or Use Problem1
- Implant subsidence1
Patient problems
- Implant Pain1
- Joint Laxity1
- Medical device site infection1
- Unspecified Infection1
Recent adverse event reports
The 4 most recent of 4 reports, in the reporter's own words as published by the FDA.
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 ↗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 ↗InjuryJul 3, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
HIP LUXATION OCCURRED 1 DAY AFTER THE PRIMARY SURGERY. THE STEM WAS TOO MUCH ANTEVERTED. ALL DEVICES REVISED.
Patient problems: Joint Laxity
MAUDE report 19667046 ↗InjuryAug 30, 2023Device Appears to Trigger Rejection; Device Appears to Trigger Rejection
AT ABOUT 1 YEAR AND 11 MONTHS AFTER THE PRIMARY, THE PATIENT WAS REVISED BECAUSE OF INFECTION CAUSED BY STAPHYLOCOCCUS CAPITIS. THE INFECTION LED TO STEM SUBSIDENCE. ALL THE IMPLANTS HAVE BEEN REMOVED SUCCESSFULLY.
Patient problems: Unspecified Infection
MAUDE report 17649039 ↗
Other Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented devices
- BIOLOX DELTA 1365-32-310Depuy Orthopaedics, Inc. · Prosthesis, hip, semi-constrained, metal/ceramic/polymer, cemented or non-porous, uncemented551 reports
- PINNACLE ALTRX 1221-36-052Depuy Orthopaedics, Inc. · Prosthesis, hip, semi-constrained, metal/ceramic/polymer, cemented or non-porous, uncemented481 reports
- BIOLOX DELTA 1365-32-320Depuy Orthopaedics, Inc. · Prosthesis, hip, semi-constrained, metal/ceramic/polymer, cemented or non-porous, uncemented1 death314 reports
- BIOLOX DELTA 1365-36-720Depuy Orthopaedics, Inc. · Prosthesis, hip, semi-constrained, metal/ceramic/polymer, cemented or non-porous, uncemented1 death189 reports
- DJO SURGICAL 400-03-362Encore Medical, L.P. · Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented187 reports
- Anthology 71365705Smith & Nephew, Inc. · Prosthesis, hip, semi-constrained, metal/ceramic/polymer, cemented or non-porous, uncemented176 reports
- BIOLOX DELTA 1365-40-710Depuy Orthopaedics, Inc. · Prosthesis, hip, semi-constrained, metal/ceramic/polymer, cemented or non-porous, uncemented170 reports
- PINNACLE GRIPTION 1217-32-054Depuy Orthopaedics, Inc. · Prosthesis, hip, semi-constrained, metal/ceramic/polymer, cemented or non-porous, uncemented169 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.
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