CoCr Femoral Ball Head 01.25.023Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 07630030805172), received between Jul 25, 2017 and Jul 23, 2019 — classified as 3 injuries, 1 malfunction.

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 (K072857); 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.

• InjuryJul 23, 2019Device Dislodged or Dislocated

  THE PATIENT CAME IN COMPLAINING OF PAIN DUE TO A DISLOCATION OF THE HEAD FROM THE LINER 2 YEARS AFTER PRIMARY. THE SURGEON REVISED THE MEDACTA CUP AND LINER WITH ANOTHER COMPANY'S PRODUCT AND REVISED THE MEDACTA HEAD WITH A MEDACTA HEAD. THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: Joint Dislocation

  MAUDE report 8814970 ↗
• InjuryJun 12, 2019Inadequacy of Device Shape and/or Size

  THE PATIENT CAME IN COMPLAINING OF PAIN DUE TO A LEG LENGTH DISCREPANCY 1 MONTH AFTER PRIMARY. THE SURGEON REVISED ONLY THE 32MM COCR HEAD L WITH A 32MM COCR HEAD S AND THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: Pain

  MAUDE report 8691459 ↗
• MalfunctionJul 26, 2018Difficult to Open or Remove Packaging Material; Difficult to Open or Remove Packaging Material

  UPON OPENING A FEMORAL HEAD IMPLANT, IT WAS FOUND THE INTERNAL PACKAGING WAS STUCK INSIDE THE EXTERNAL PACKAGING. THEY TRIED SEVERAL TIME TO GET THE INTERNAL PACKAGING OUT BUT WERE NOT ABLE TO WHILE KEEPING THE INTERNAL PACKAGING AND IMPLANT STERILE. EVEN OUTSIDE THE STERILE FEEL THE IMPLANT IS EXTREMELY DIFFICULT TO REMOVE. ANOTHER FEMORAL HEAD WAS OPENED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7722401 ↗
• InjuryJul 25, 2017Adverse Event Without Identified Device or Use Problem

  REVISION SURGERY DUE TO HIP LUXATION. HEAD AND LINER WERE EXPLANTED. NO TRAUMA WAS REPORTED.

  Patient problems: Joint Dislocation

  MAUDE report 6740185 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K072857. 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