CoCr Femoral Ball Head 01.25.022Recalls & reported problems

Summary

The FDA's MAUDE database contains 8 adverse event reports that list this exact device (DI 07630030805165), received between Nov 13, 2018 and Oct 21, 2024 — classified as 8 injuries.

The most frequently reported specific device problem is “Device Dislodged or Dislocated” (5 reports).

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 8 most recent of 8 reports, in the reporter's own words as published by the FDA.

• InjuryOct 21, 2024Device Dislodged or Dislocated; Device Dislodged or Dislocated

  AT ABOUT 4 YEARS AND 9 MONTHS AFTER PRIMARY, THE PATENT CAME IN REPORTING PAIN DUE TO A JOINT LUXATION AND THE CAUSE IS UNKNOWN. THE SURGEON REVISED THE HEAD AND THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: Implant Pain

  MAUDE report 20493064 ↗
• InjuryOct 25, 2021Device Dislodged or Dislocated

  ABOUT 3 WEEKS AFTER THE PRIMARY SURGERY THE SURGEON REVISED THE HEAD AND LINER DUE TO DISLOCATION (HEAD-LINER) AFTER THE PHYSIOTHERAPY.

  Patient problems: Joint Dislocation

  MAUDE report 12688360 ↗
• InjuryOct 27, 2020Appropriate Device Problem Term/Code Not Available

  THE PATIENT CAME IN 10 MONTHS AFTER THE PRIMARY SURGERY REPORTING INSTABILITY( FELT IMBALANCED DUE TO UNKNOWN REASONS) AND THE CAUSE OF THE INSTABILITY IS UNKNOWN. THE SURGEON REVISED THE CRCO BALL HEAD Ø32 - SIZE "M" 0 WITH A 28MM BIOLOX OPTION HEAD AND ADDED A BIOLOX OPTION SLEEVE XL. THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: Insufficient Information

  MAUDE report 10741365 ↗
• InjuryAug 19, 2020Device Dislodged or Dislocated

  THE PATIENT CAME IN REPORTING PAIN DUE TO A DISLOCATION OF THE HIP METALLIC BALL HEAD FROM THE LINER. 7 YEARS AND 11 MONTHS AFTER PRIMARY THE SURGEON REVISED THE CUP AND LINER AND THE SURGERY WAS COMPLETED SUCCESSFULLY. THE METALLIC HEAD WAS LEFT IN PLACE.

  Patient problems: Joint Dislocation

  MAUDE report 10425795 ↗
• InjuryMar 25, 2020Adverse Event Without Identified Device or Use Problem

  THE PATIENT CAME IN DUE TO SIGNS OF AN INFECTION 14 DAYS AFTER THE PRIMARY SURGERY, AND THE PATHOGEN IS UNKNOWN. IT WAS OBSERVED THAT THERE WAS AN INFECTION AT THE IMPLANT SITE. THE ORIGINAL FEMORAL HEAD WAS REMOVED IN ORDER TO PERFORM A THOROUGH WASHOUT AT THE SITE OF THE INFECTION. THE HEAD WAS REVISED.

  Patient problems: Unspecified Infection

  MAUDE report 9876849 ↗
• InjuryNov 11, 2019Device Dislodged or Dislocated

  THE PATIENT HAD A PRIMARY HIP SURGERY AND WAS IMPLANTED WITH ALL COMPETITOR ITEMS. THE DATE OF THE PRIMARY HIP SURGERY IS UNKNOWN. SUBSEQUENTLY, THE PATIENT CAME IN COMPLAINING OF PAIN AND THE CAUSE OF THE PAIN WAS UNKNOWN. THE SURGEON REMOVED THE COMPETITOR IMPLANTS AND IMPLANTED THE PATIENT WITH A MEDACTA HEAD, CUP, AND LINER. THE SURGERY WAS COMPLETED SUCCESSFULLY. PRESENTLY, ON (B)(6) 2019 (1 MONTH AFTER THE FIRST REVISION SURGERY), THE PATIENT CAME IN COMPLAINING OF PAIN CAUSED BY A DISLOCATION OF THE HEAD FROM THE LINER. THE SURGEON REVISED THE CUP, LINER, AND HEAD AND THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: Joint Dislocation

  MAUDE report 9304129 ↗
• InjuryApr 11, 2019Device Dislodged or Dislocated

  THREE WEEKS AFTER PRIMARY SURGERY, THE PATIENT MOVED IN BED SO THERE WAS A LUXATION OF THE HIP. THE HEAD DISLOCATED FROM THE LINER. IN ADDITION TO THE LUXATION, THE STEM GOT TURNED/ROTATED. THE STEM WAS REPLACED BY AN AMISTEM-C. HEAD WAS REPLACED AS WELL. PRIMARY SURGERY WAS IN AMIS. THE BONE QUALITY WAS NOT SO GOOD, IN PARTICULAR ON THE PROXIMAL PART.

  Patient problems: Joint Dislocation

  MAUDE report 8503595 ↗
• InjuryNov 13, 2018Microbial Contamination of Device

  ABOUT 10 MONTHS AFTER PRIMARY THE SURGEON REVISED THE PATIENT FOR AN INFECTION CASE. THE PATIENT HAD ALREADY UNDERGONE TO TWO WASHOUT BEFORE DETECTING THE INFECTION. THE PATHOGEN WAS FOUND TO BE STAPHYLOCOCCUS AUREUS. LINER AND HEAD SWAP WAS PERFORMED. THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: Unspecified Infection

  MAUDE report 8064114 ↗

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