Quadra R femoral stems 01.12.061Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 07630030802393), received between Oct 12, 2017 and May 8, 2025 — classified as 2 injuries.

The most frequently reported specific device problem is “Fracture” (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 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• InjuryMay 8, 2025Fracture; Fracture

  PATIENT UNDERWENT PRIMARY THA YEARS AGO. IN 2011 HAD TO UNDERGO REVISION SURGERY WHERE PRIMARY STEM WAS REPLACED BY SPACER. ON THE (B)(6) 2012 A 2ND REVISION SURGERY WAS PERFORMED. IMPLANTS USED FOR THIS REVISION ARE QUADRA-R SIZE 1, BIPOLAR HEAD SIZE 48, AND METAL FEMORAL HEAD SIZE L. ON THE (B)(6) 2019 3RD REVISION SURGERY WITH REVISION OF CUP, LINER AND HEAD. COMPETITOR COMPONENTS IMPLANTED, INCLUDING MERETE BIOBALL SIZE XL SLEEVE AND CERAMIC HEAD (OFF-LABEL) WHILE QUADRA-R STEM REMAINED IN PLACE. ON MONDAY, (B)(6) 2025 PATIENT CAME TO THE HOSPITAL BAD ISCHL WITH PAIN AND LACK OF MOBILITY IN HIS RIGHT HIP. XRAY WAS PERFORMED AND BROKEN NECK OF QUADRA-R WAS FOUND. REVISION PERFORMED ON (B)(6) 2025. STEM AND HEAD WERE REVISED TO COMPETITOR IMPLANTS.

  Patient problems: Implant Pain; Loss of Range of Motion

  MAUDE report 21984139 ↗
• InjuryOct 12, 2017Adverse Event Without Identified Device or Use Problem

  REVISION SURGERY DUE TO INFECTION. THE SURGEON REPLACED THE MEDACTA STEM AND OTHER NON-MEDACTA COMPONENTS (CUP, HEAD AND LINER). THE SURGERY WAS COMPLETED SUCCESSFULLY. THE PATHOGEN WON'T BE AVAILABLE.

  Patient problems: Unspecified Infection

  MAUDE report 6944531 ↗

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