Quadra C femoral stems 01.12.041Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 07630030802225), received between Nov 17, 2017 and Sep 25, 2024 — classified as 4 injuries.

The most frequently reported specific device problem is “Fracture” (2 reports).

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

Recent adverse event reports

The 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• InjurySep 25, 2024Device Appears to Trigger Rejection; Device Appears to Trigger Rejection

  REVISION SURGERY PERFORMED ABOUT 1 YEAR AND 6 MONTHS AFTER PRIMARY SURGERY DUE TO INFECTION. ALL COMPONENTS REVISED.

  Patient problems: Medical device site infection

  MAUDE report 20299957 ↗
• InjuryJul 29, 2019Fracture

  THE PATIENT HAD A TOTAL HIP REPLACEMENT (B)(6) 2017 WHICH HAD TO BE REVISED ON THE (B)(6) 2017 DUE TO FRACTURE (NO IMPLANTS HAS BEEN REMOVED). THE PATIENT THEN SUFFERED FROM AN INFECTION WHICH RESULTED IN ALL IMPLANTS NEEDED TO BE EXTRACTED ((B)(6) 2018). ON (B)(6) 2019 ALL IMPLANTS WERE REMOVED DUE TO INFECTION, PATHOGEN UNKNOWN.

  Patient problems: Unspecified Infection

  MAUDE report 8835298 ↗
• InjuryMar 20, 2019Loosening of Implant Not Related to Bone-Ingrowth

  ON (B)(6) 2019 WE WERE INFORMED ABOUT A PATIENT WHO CAME IN COMPLAINING OF PAIN 4 YEARS AND 8 MONTHS AFTER THE PRIMARY SURGERY DUE TO AN ASEPTIC LOOSENING OF THE STEM AND A LOOSE CUP. THE CAUSE OF THE LOOSE CUP IS UNKNOWN. ON THE FOLLOWING DAY, THE SURGEON REVISED THE CUP, LINER, HEAD AND STEM AND THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: Joint Disorder

  MAUDE report 8436664 ↗
• InjuryNov 17, 2017Fracture; Loose or Intermittent Connection

  THE PATIENT REPORTED THIGH PAIN AND UPON X-RAY INVESTIGATION THE SURGEON DIAGNOSED A LOOSE CEMENT MANTLE AN STEM LOOSENING IN THE PROXIMAL THIRD OF THE FEMUR. REVISION SURGERY WAS REQUIRED, IN WHICH THE STEM WAS REPLACED AFTER CLEARING OF THE CEMENT MANTLE. IT WAS CONFIRMED THAT A SUBSTANTIAL CEMENT MANTLE FRACTURE HAD OCCURRED.

  Patient problems: Joint Disorder

  MAUDE report 7040107 ↗

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