Quadra C Femoral Stems 01.12.41SNRecalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 07630030802799), received between Jan 18, 2021 and Jan 18, 2021 — classified as 1 injury.

1 other recall cover devices cleared under the same FDA submission (K103189); 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

Recent adverse event reports

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

• InjuryJan 18, 2021Appropriate Device Problem Term/Code Not Available

  ON (B)(6) 2020, ONE MONTH AFTER THE PRIMARY SURGERY A WASHOUT WAS PERFORMED, ON (B)(6)2020, THE SURGEON PERFORMED AGAIN A WASHOUT AND REVISED THE LINER AND HEAD DUE TO INFECTION. BLOOD CULTURE STILL POSITIVE FOR E COLI. THE SURGEON FINALLY REVISED ALL IMPLANTS ON (B)(6) 2021 VIA POSTERIOR APPROACH AND IMPLANTED COMPETITOR IMPLANTS.

  Patient problems: Bacterial Infection

  MAUDE report 11185283 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K103189. 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