Quadra P femoral stems 01.12.161Recalls & reported problems
Medacta International SA · Quadra-P Collared Std. #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 07630040731850), received between Oct 27, 2022 and May 27, 2026 — classified as 3 injuries.
The most frequently reported specific device problem is “Device Appears to Trigger Rejection” (3 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 Rejection3
Patient problems
- Unspecified Infection2
- 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 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 ↗InjuryApr 13, 2023Device Appears to Trigger Rejection; Device Appears to Trigger Rejection
AT ABOUT 3 WEEKS AFTER THE PRIMARY SURGERY, 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 PERMANENT HARDWARE. THE SURGERY WAS COMPLETED SUCCESSFULLY.
Patient problems: Unspecified Infection
MAUDE report 16731134 ↗InjuryOct 27, 2022Device Appears to Trigger Rejection; Device Appears to Trigger Rejection
THE PATIENT CAME IN DUE TO SIGNS OF AN INFECTION AND THE PATHOGEN IS UNKNOWN. AT ABOUT 1 MONTH FROM THE PRIMARY SURGERY THE SURGEON PERFORMED A WASHOUT AND REVISED THE STEM AND HEAD. THE SURGERY WAS COMPLETED SUCCESSFULLY.
Patient problems: Unspecified Infection
MAUDE report 15680512 ↗
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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