Quadra P femoral stems 01.12.122Recalls & reported problems
Medacta International SA · Quadra-P Std. #2 · 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
- 5
- Deaths reported
- 0
- Injuries reported
- 5
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 07630040720434), received between Mar 6, 2020 and Sep 9, 2024 — classified as 5 injuries.
The most frequently reported specific device problem is “Migration” (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
- Migration2
- Adverse Event Without Identified Device or Use Problem1
- Device Appears to Trigger Rejection1
- Fracture1
Patient problems
- Unequal Limb Length2
- Bone Fracture(s)1
- Medical device site infection1
- No Clinical Signs, Symptoms or Conditions1
Recent adverse event reports
The 5 most recent of 5 reports, in the reporter's own words as published by the FDA.
InjurySep 9, 2024Device Appears to Trigger Rejection; Device Appears to Trigger Rejection
AT ABOUT 4 DAYS AFTER THE PRIMARY, THE PATIENT CAME IN DUE TO SIGNS OF INFECTION AND THE PATHOGEN IS UNKNOWN. THE SURGEON REVISED ALL MEDACTA HARDWARE AND REIMPLANTED PERMANENT PRODUCT. THE SURGERY WAS COMPLETED SUCCESSFULLY.
Patient problems: Medical device site infection
MAUDE report 20167706 ↗InjuryMay 17, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
REVISION SURGERY PERFORMED 4 DAYS AFTER THE PRIMARY SURGERY DUE TO THE INCREASED POSTOPERATIVE LENGTH OF THE LEG. A SMALLER SIZED CEMENTED STEM HAS BEEN IMPLANTED WITH A DOUBLE MOBILITY SYSTEM.
Patient problems: Unequal Limb Length
MAUDE report 19339180 ↗InjuryApr 4, 2024Migration; Migration
REVISION DUE TO A SUBSIDED STEM AND THE CAUSE IS UNKNOWN. THE PATIENT WAS REPORTING A LEG LENGTH DISCREPANCY. AT ABOUT 9 MONTHS POST-PRIMARY THE SURGEON REVISED THE HEAD AND THE LINER TO GIVE THE PATIENT MORE LENGTH. THE STEM WAS NOT REMOVED BECAUSE IT WAS WELL-FIXED. THE SURGERY WAS COMPLETED SUCCESSFULLY.
Patient problems: Unequal Limb Length
MAUDE report 19040033 ↗InjuryNov 20, 2023Migration; Migration
REVISION FOR QUADRA P SUBSIDENCE, 3 MONTHS AFTER PRIMARY. THE STEM THE HEAD AND THE LINER HAVE BEEN REVISED SUCCESSFULLY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18171358 ↗InjuryMar 6, 2020Fracture
THE PATIENT CAME IN REPORTING PAIN DUE TO A PERIPROSTHETIC FRACTURE. THE SURGEON PUT CABLES AROUND THE FEMUR TO SECURE THE FRACTURE AND REVISED THE HEAD 28 DAYS AFTER PRIMARY. THE SURGERY WAS COMPLETED SUCCESSFULLY.
Patient problems: Bone Fracture(s)
MAUDE report 9799722 ↗
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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