Quadra P femoral stems 01.12.126Recalls & reported problems
Medacta International SA · Quadra-P Std. #6 · 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 07630040720472), received between Dec 5, 2023 and Nov 22, 2024 — classified as 3 injuries.
The most frequently reported specific device problem is “Loss of Osseointegration” (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
- Loss of Osseointegration2
- Device Appears to Trigger Rejection1
Patient problems
- Inadequate Osseointegration1
- Medical device site infection1
- No Clinical Signs, Symptoms or Conditions1
Recent adverse event reports
The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.
InjuryNov 22, 2024Device Appears to Trigger Rejection; Device Appears to Trigger Rejection
ON (B)(6) 2021, THE PATIENT HAD PRIMARY HIP SURGERY. ON (B)(6) 2021, REVISION SURGERY FOR JOINT LUXATION. HEAD AND LINER REVISED. ON (B)(6) 2024, THE PATIENT HAD PAIN AND FEMUR ASEPTIC LOOSENING DUE TO A TRAUMATIC EVENT. THE SURGEON REVISED STEM AND HEAD. ON (B)(6) 2024, EXPLANTATION OF ALL COMPONENTS DUE TO INFECTION (STAPH AUREUS).
Patient problems: Medical device site infection
MAUDE report 20757905 ↗InjuryDec 6, 2023Loss of Osseointegration; Loss of Osseointegration
THE PATIENT HAD PAIN DUE TO LOOSE STEM. AT ABOUT 3 YEARS AND 5 MONTHS POST PRIMARY THE SURGEON REVISED THE MEDACTA STEM AND HEAD WITH COMPETITOR'S PRODUCTS AND REVISED THE MEDACTA LINER WITH A MEDACTA LINER. THE SURGERY WAS COMPLETED SUCCESSFULLY.
Patient problems: Inadequate Osseointegration
MAUDE report 18272460 ↗InjuryDec 5, 2023Loss of Osseointegration; Loss of Osseointegration
THE SURGEON NOTED RADIOLUCENT LINES ON RADIOGRAPHS 4,5 MONTHS AFTER SURGERY AND DIAGNOSED MILD STEM LOOSENING IN ZONE (B)(6) 2014. THE PATIENT DOES NOT COMPLAIN OF ANY PAIN OR DISCOMFORT. REVISION SURGERY IS NOT PLANNED. THE PATIENT WILL BE MONITORED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18266170 ↗
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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