CoCr Femoral Ball Head 01.25.021Recalls & reported problems

Summary

The FDA's MAUDE database contains 11 adverse event reports that list this exact device (DI 07630030805158), received between Nov 16, 2018 and Dec 18, 2025 — classified as 11 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 11 most recent of 11 reports, in the reporter's own words as published by the FDA.

• InjuryDec 18, 2025Device Appears to Trigger Rejection; Device Appears to Trigger Rejection

  FIVE MONTHS AFTER THE PRIMARY SURGERY, THE PATIENT REPORTED PERSISTENT PAIN AND SWELLING. A NICKEL ALLERGY WAS DIAGNOSED. BASED ON THIS AND THE X-RAY FINDINGS, A REVISION WAS PERFORMED. INTRAOPERATIVELY, THE STEM WAS STABLE, SO ONLY THE HEAD WAS EXCHANGED WITH A BIOLOX OPTION.

  Patient problems: Metal Related Pathology

  MAUDE report 23836916 ↗
• InjuryDec 21, 2023Device Dislodged or Dislocated; Device Dislodged or Dislocated

  HIP INSTABILITY DUE TO A DISLOCATION OF THE HEAD FROM THE LINER. ABOUT 1 MONTH POST PRIMARY THE SURGEON REVISED THE MEDACTA HEAD WITH ANOTHER MEDACTA HEAD AND THE MEDACTA CUP AND LINER WERE REVISED TO A COMPETITOR'S PRODUCT. THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available

  MAUDE report 18380308 ↗
• InjuryJun 1, 2023Device Appears to Trigger Rejection; Device Appears to Trigger Rejection

  THE PATIENT CAME IN DUE TO SIGNS OF AN INFECTION AND THE PATHOGEN IS UNKNOWN. ABOUT 2 MONTHS AND 10 DAYS AFTER THE PRIMARY SURGERY, THE SURGEON REMOVED ALL COMPONENTS AND IMPLANTED PERMANENT HARDWARE. THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: Unspecified Infection

  MAUDE report 17037725 ↗
• InjuryApr 12, 2023Device Appears to Trigger Rejection; Device Appears to Trigger Rejection

  THE PATIENT CAME IN DUE TO SIGNS OF AN INFECTION AND THE PATHOGEN IS UNKNOWN. AT 1 MONTH FROM PRIMARY THE SURGEON PERFORMED A WASHOUT AND REVISED THE HEAD AND LINER. THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: Medical device site infection

  MAUDE report 16724726 ↗
• InjuryApr 4, 2022Loosening of Implant Not Related to Bone-Ingrowth

  THE PATIENT CAME IN REPORTING PAIN AND THE CAUSE OF THE PAIN IS LAXITY. AT 1 YEAR AND 1 MONTH AFTER THE PRIMARY SURGERY, THE SURGEON FOUND THE STEM TO BE WELL FIXED, SO HE DECIDED TO ONLY REVISE THE HEAD. THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: Pain

  MAUDE report 13995306 ↗
• InjuryJan 8, 2021Device Dislodged or Dislocated

  DISLOCATION HEAD FROM LINER (NO LOOSENING) AFTER 2 MONTHS FROM THE PRIMARY SURGERY. FEMORAL HEAD HAS BEEN SUCCESSFULLY REVISED.

  Patient problems: Joint Dislocation

  MAUDE report 11138889 ↗
• InjuryDec 1, 2020Device Dislodged or Dislocated

  THE PATIENT CAME IN REPORTING PAIN DUE TO A DISLOCATION OF THE HEAD FROM THE LINER 4 DAYS AFTER THE PRIMARY SURGERY. THE CAUSE OF THE DISLOCATION IS UNKNOWN. THE SURGEON REVISED THE HEAD AND LINER AND THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: Failure of Implant; Pain

  MAUDE report 10928298 ↗
• InjuryNov 18, 2019Loose or Intermittent Connection

  REVISION SURGERY PERFORMED 2,5 MONTHS AFTER THE PRIMARY DUE TO LOOSE STEM AND CUP. ALL IMPLANTS WERE REVISED. THE PATIENT WAS IN ISOLATION BECAUSE OF MRSA INFECTION AND HE ALSO HAS A LONG HISTORY OF DISEASES. IT IS UNKNOWN WHAT WAS THE PRIMARY REASON OF THE REVISION SURGERY (INFECTION, PAIN OR IMPLANTS LOOSENING).

  Patient problems: Joint Disorder; Unspecified Infection

  MAUDE report 9334638 ↗
• InjuryOct 22, 2019Device Dislodged or Dislocated; Appropriate Device Problem Term/Code Not Available

  THE PATIENT CAME IN COMPLAINING OF PAIN DUE TO A DISLOCATION OF THE HEAD FROM THE LINER 2 MONTHS AFTER PRIMARY. THE SURGEON REVISED THE CUP, SCREWS, STEM, AND LINER WITH COMPETITOR ITEMS, AND REVISED THE HEAD WITH A MEDACTA HEAD. THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: Joint Dislocation

  MAUDE report 9217404 ↗
• InjuryJul 24, 2019Appropriate Device Problem Term/Code Not Available

  THE BIOPSY SHOWED SIGNS OF INFECTION SO THE SURGEON DECIDED TO REVISE HEAD, LINER AND CUP 5 DAYS AFTER PRIMARY. THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: Unspecified Infection

  MAUDE report 8822106 ↗
• InjuryNov 16, 2018Device Dislodged or Dislocated

  THE PATIENT CAME IN COMPLAINING OF PAIN 3 YEARS AND HALF AFTER THE PRIMARY. THE HEAD DISLOCATED FROM THE LINER ON THE PATIENT'S RIGHT HIP. THE SURGEON REVISED THE CUP, LINER AND HEAD.

  Patient problems: Pain

  MAUDE report 8077518 ↗

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