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Quadra C femoral stems 01.12.042Recalls & reported problems

Medacta International SA · Quadra C Cemented Standard stem size 2 · Class 2 · Implant

All models of Quadra C femoral stems (11)

Data updated Oct 18, 2026 from official FDA records · Editorial policy

Adverse event reports
1
Deaths reported
0
Injuries reported
1
Recalls naming it
0

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 07630030802232), received between Nov 28, 2022 and Nov 28, 2022 — classified as 1 injury.

1 other recall cover devices cleared under the same FDA submission (K083558); they may or may not involve this specific model.

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.

Most reported problems

Device problems

  • Appropriate Device Problem Term/Code Not Available1

Patient problems

  • Bone Fracture(s)1

Recent adverse event reports

The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

  • InjuryNov 28, 2022Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available

    THE PATIENT PRESENTED WITH A PERIPROSTHETIC FEMORAL FRACTURE ABOUT 1 MONTH AFTER THE PRIMARY SURGERY. THE SURGEON REPLACED THE STEM AND HEAD WITH NON-MEDACTA IMPLANTS BUT LEFT THE CUP AND LINER IN SITU. HE COULD NOT CONFIRM WHAT CAUSED THE FRACTURE OR WHEN THE FRACTURE OCCURRED.

    Patient problems: Bone Fracture(s)

    MAUDE report 15869293 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K083558. One submission often covers many models, so check the product and lot details in each record.

  • Z-0791-2013 · Dec 17, 2012 · Terminated
    Medacta Quadra Trial Broach size 0 part # 01.10.10.045, for use with the Medacta Total Hip Prosthesis System. Product Usage - used to broach the intramedullary canal of the femur

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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