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Quadra P femoral stems 01.12.121Recalls & reported problems

Medacta International SA · Quadra-P 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 07630040720427), received between Aug 20, 2020 and Mar 10, 2026 — classified as 3 injuries.

The most frequently reported specific device problem is “Osseointegration Problem” (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

Nov 2023: 0 reportsDec 2023: 0 reportsJan 2024: 0 reportsFeb 2024: 0 reportsMar 2024: 0 reportsApr 2024: 0 reportsMay 2024: 0 reportsJun 2024: 0 reportsJul 2024: 0 reportsAug 2024: 0 reportsSep 2024: 0 reportsOct 2024: 0 reportsNov 2024: 0 reportsDec 2024: 0 reportsJan 2025: 0 reportsFeb 2025: 0 reportsMar 2025: 0 reportsApr 2025: 0 reportsMay 2025: 0 reportsJun 2025: 0 reportsJul 2025: 0 reportsAug 2025: 0 reportsSep 2025: 0 reportsOct 2025: 0 reportsNov 2025: 0 reportsDec 2025: 0 reportsJan 2026: 0 reportsFeb 2026: 0 reportsMar 2026: 1 reportsApr 2026: 0 reportsMay 2026: 0 reportsJun 2026: 0 reportsJul 2026: 0 reportsAug 2026: 0 reportsSep 2026: 0 reportsOct 2026: 0 reports2024202520261
Last 36 months. The most recent month may be incomplete.

Most reported problems

Device problems

  • Osseointegration Problem2
  • Appropriate Device Problem Term/Code Not Available1
  • Fracture1

Patient problems

  • Aseptic loosening1
  • Hip Fracture1
  • Inadequate Osseointegration1

Recent adverse event reports

The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

  • InjuryMar 10, 2026Osseointegration Problem

    AT ABOUT 1 YEAR 11 MONTHS AFTER THE PRIMARY, THE PATIENT CAME IN PRESENTING PAIN DUE TO A LOOSE STEM AND THE CAUSE IS UNKNOWN. THERE ARE NO INDICATIONS OF TRAUMA. THE SURGEON REVISED THE STEM AND HEAD TO COMPETITOR IMPLANTS, AND REVISED THE LINER TO SAME SIZE MEDACTA LINER. THE SURGERY WAS COMPLETED SUCCESSFULLY.

    Patient problems: Aseptic loosening

    MAUDE report 24558210 ↗
  • InjuryOct 17, 2022Osseointegration Problem; Osseointegration Problem

    AT ABOUT 6 MONTHS AFTER THE PRIMARY SURGERY, THE PATIENT CAME IN REPORTING HIP PAIN PROBABLY DUE TO LACKING OF OSTEOINTEGRATION. STEM AND HEAD WERE REVISED AND THE SURGERY WAS COMPLETED SUCCESSFULLY.

    Patient problems: Inadequate Osseointegration

    MAUDE report 15615073 ↗
  • InjuryAug 20, 2020Fracture; Appropriate Device Problem Term/Code Not Available

    THE PATIENT CAME IN REPORTING PAIN DUE TO A FRACTURED FEMUR. THE CAUSE OF THE FRACTURE IS UNKNOWN. THE SURGEON CABLED THE FRACTURE AND REVISED THE HEAD, STEM AND LINER. THE SURGERY WAS COMPLETED SUCCESSFULLY.

    Patient problems: Hip Fracture

    MAUDE report 10429824 ↗

Other Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented devices

All Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented devices →

Sources and updates

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