Quadra C femoral stems 01.12.043Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 07630030802249), received between Jan 4, 2018 and Mar 18, 2020 — classified as 4 injuries.

The most frequently reported specific device problem is “Device Dislodged or Dislocated” (1 report).

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.

• InjuryMar 18, 2020Loose or Intermittent Connection; Appropriate Device Problem Term/Code Not Available

  HIP REVISION AFTER 3 YEARS AND 7 MONTHS FROM THE PRIMARY DUE TO STEM LOOSENING AND INFECTION SUSPICIOUS. ALL IMPLANTS WERE REVISED, NO INFECTION PRESENT.

  Patient problems: Joint Disorder

  MAUDE report 9848075 ↗
• InjuryOct 3, 2018Microbial Contamination of Device

  THE PATIENT INITIALLY HAD A COMPETITOR STEM AND CUP IMPLANTED WHICH WAS REVISED FOR INFECTION. THE SURGEON IMPLANTED A QUARDA C STEM AND VERSACEM/DM CONSTRUCT IN AS A 1ST STAGE REVISION (B)(6) 2018. THE INFECTION REMAINED ACTIVE AND THE PATIENT HAD A POST OPERATIVE FEMORAL FRACTURE. THE PATIENT WAS BOOKED FOR ANOTHER SURGERY TO REMOVE COMPONENTS AND REPAIR FRACTURE. FRACTURE WAS NOT REPAIRED DUE TO PATIENT BLEEDING UNCONTROLLABLY. PATIENT TRANSFERRED TO ANOTHER HOSPITAL.

  Patient problems: Bone Fracture(s); Hemorrhage/Blood Loss/Bleeding; Unspecified Infection

  MAUDE report 7929613 ↗
• InjuryJun 26, 2018Device Dislodged or Dislocated

  REVISION SURGERY AFTER ABOUT 6 YEARS AND 8 MONTHS FROM THE PRIMARY DUE TO STEM MOBILIZATION. STEM, HEAD AND LINER WERE REVISED.

  Patient problems: Joint Disorder

  MAUDE report 7637646 ↗
• InjuryJan 4, 2018Device Slipped; Mechanical Jam

  DURING INSERTING A QUADRA-C STEM, THE IMPACTOR WAS JAMMED WITH THE IMPLANT. WHEN REMOVING THE IMPACTOR, THE CEMENTED STEM HAS SLIPPED OUT OF THE SEMI-HARDENED CEMENT MANTLE. RESIDUAL CEMENT WAS REMOVED AND THEN ANOTHER CEMENTED WAS IMPLANTED.

  Patient problems: No Code Available

  MAUDE report 7163360 ↗

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