Quadra R femoral stems 01.12.062Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 07630030802409), received between Apr 29, 2019 and Dec 14, 2022 — classified as 3 injuries.

The most frequently reported specific device problem is “Break” (1 report).

1 other recall cover devices cleared under the same FDA submission (K082792, K250450); 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 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• InjuryDec 14, 2022Migration or Expulsion of Device; Migration or Expulsion of Device

  THE PATIENT CAME IN REPORTING PAIN DUE TO A SUBSIDED STEM AND THE CAUSE IS UNKNOWN. ABOUT 2 MONTHS AND A HALF, THE SURGEON REVISED THE STEM, HEAD, AND LINER. THE SURGERY WAS COMPLETED SUCCESSFULLY. IMPLANTED STEM: 01.22.730 MONOBLOCK STEM Ø21MM L 240MM LAT.

  Patient problems: Pain

  MAUDE report 15977589 ↗
• InjuryAug 3, 2020Break; Break

  REVISION SURGERY PERFORMED DUE TO BREAKAGE AT THE LEVEL OF THE MID-THIRD OF THE STEM BODY, 5 YEARS AND 6 MONTHS AFTER FROM WHEN THE STEM HAS BEEN IMPLANTED. THE BROKEN QUADRA-R STEM WAS IMPLANTED DURING A REVISION SURGERY ON (B)(6) 2014, IT WAS ALSO IMPLANTED A COMPETITOR TROCHANTERIC PLATE. THE TROCHANTERIC PLATE WAS RECOGNIZED AS BROKEN ON (B)(6) 2015, IT HAS BEEN REVISED ON (B)(6) 2019. ON (B)(6) 2020 THE BROKEN QUADRA-R STEM HAS BEEN REVISED. A DOWNFALL WAS REPORTED IN THE MEDICAL HISTORY OF THE PATIENT 2 WEEKS BEFORE THE STEM BREAKAGE.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 10354782 ↗
• InjuryApr 29, 2019Appropriate Device Problem Term/Code Not Available

  THE PATIENT HAD A PRIMARY HIP SURGERY ON (B)(6) 2018. AFTER A FALL THE SURGEON REVISED THE STEM, THE HEAD, THE LINER (2 MONTHS AFTER PRIMARY) AND CABLED THE FEMUR FRACTURE CAUSED BY THE FALL. ABOUT 5 MONTHS AFTER THE FIRST REVISION THE SURGEON REVISED NEWLY THE PATIENT JOINT FOR A STEM SUBSIDENCE. THE STEM AND HEAD REVISED WITH ANOTHER COMPANY'S PRODUCT. THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: Joint Disorder

  MAUDE report 8560460 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K082792, K250450. 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