Quadra C femoral stems 01.12.040Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 07630030802218), received between Jun 28, 2017 and Oct 17, 2019 — classified as 3 injuries, 1 malfunction.

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.

• InjuryOct 17, 2019Appropriate Device Problem Term/Code Not Available

  THE PATIENT HAD A PRIMARY HIP SURGERY ON (B)(6) 2018. SUBSEQUENTLY, ON (B)(6) 2018, THE PATIENT CAME IN DUE TO SIGNS OF INFECTION AND THE PATHOGEN WAS IDENTIFIED AS STREPTOCOCCUS. THE SURGEON PERFORMED AN I&D AND REVISED THE STEM, HEAD AND LINER. THE SURGERY WAS COMPLETED SUCCESSFULLY. COMPLAINT 1839-18 WAS FILED. ON (B)(6) 2019, THE PATIENT CAME IN DUE TO SIGNS OF AN INFECTION. THE SURGEON PERFORMED AN I&D AND ALL IMPLANTS WERE EXPLANTED AND THE SURGEON IMPLANTED A HEAD, STEM, AND LINER WITH ANTIBIOTICS. PRESENTLY, ON (B)(6) 2019, THE PATIENT CAME IN TO HAVE PERMANENT HARDWARE IMPLANTED. THE SURGEON REMOVED THE MEDACTA HEAD, STEM, AND LINER THAT ACTED AS A SPACER AND IMPLANTED PERMANENT HARDWARE. THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: Unspecified Infection

  MAUDE report 9202083 ↗
• InjuryOct 31, 2018Fracture; Difficult to Remove; Mechanical Jam; Positioning Problem

  DURING SURGERY THE SURGEON TRIALED THE FINAL IMPLANT. THE FEMORAL CANAL WAS VERY TIGHT. THE SURGEON WAS ONLY ABLE TO GET DOWN THE 0 QUADRA BROACH. HE THEN WENT TO PUT DOWN THE SMALLEST CEMENT RESTRICTOR AND IT GOT STUCK - WOULD NOT BUDGE. SO HE TRIED TO SEE IF THE 0 CEMENTED IMPLANT WOULD FIT DOWN (PRIOR TO CEMENTING) AND TAPPED IT A FEW TIMES WITH THE INSERTOR; THEN HE COULD NOT GET THE IMPLANT OUT AS THE SCREW IN EXTRACTOR WAS NOT IN THE SET. AS THE PATIENT WAS A LOW DEMAND NURSING HOME THE SURGEON ELECTED TO LEAVE THE CEMENTED STEM IN UNCEMENTED AND ACT AS A PURE WEDGE. THE SURGERY WAS COMPLETED SUCCESSFULLY. THE PATIENT DID WELL FOR 2 MONTHS UNTIL SHE FELL AND FRACTURED THE LESSER TROCHANTER. DURING THE REVISION THE STEM EASILY CAME OUT. SURGEON'S PLAN WAS TO CABLE THE FX AND CEMENT IN A SMALLER PROSTHESIS. HE CEMENTED THE 0 QUADRA AFTER PLACING 3 CABLES (2 ON THE LESSER PIECE AND ONE IN THE SUBTROCHANTERIC AREA TO PREVENT ANY EXTENSION).

  Patient problems: Joint Disorder

  MAUDE report 8023979 ↗
• InjuryAug 3, 2017Fracture

  REVISION SURGERY ABOUT 6 YEARS AFTER PRIMARY DUE TO PERIOSTEAL FRACTURE. THE ORIGINAL QUADRA C STEM WAS LOOSE AND WAS STILL SUBSIDING DUE TO A PERIOSTEAL FRACTURE.

  Patient problems: No Code Available

  MAUDE report 6762726 ↗
• MalfunctionJun 28, 2017Tear, Rip or Hole in Device Packaging; Tear, Rip or Hole in Device Packaging

  WHEN OPENING THE PACKAGING OF THE IMPLANT, THE STEM HAD PIERCED BOTH BLISTERS, INNER AND OUTER ONE. ONLY THE WHITE EXTERNAL PACKAGING WAS NOT DAMAGED. THE STEM WASN'T IMPLANTABLE.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6672561 ↗

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