CoCr Femoral Ball Head 01.25.013Recalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 07630030805127), received between Oct 6, 2017 and Oct 31, 2025 — classified as 5 injuries.

The most frequently reported specific device problem is “Device Appears to Trigger Rejection” (2 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 5 most recent of 5 reports, in the reporter's own words as published by the FDA.

• InjuryOct 31, 2025Device Appears to Trigger Rejection; Device Appears to Trigger Rejection

  AT ABOUT 15 YEARS AND 5 MONTHS FROM PRIMARY THE PATIENT WAS REVISED DUE TO SUSPECTED POLY LINER WEAR IDENTIFIED DURING CT EXAM, ALSO USE OF METAL HEAD LED TO SUSPECT TRUNNIONOSIS. DURING REVISION TRUNNIONOSIS WAS CONFIRMED WHILE THE LINER DID NOT SEEM TO BE TOO WORN. METAL HEAD WAS SUBSTITUTED WITH A CERAMIC ONE AND LINER WITH AN HC ONE. STEM WAS NOT REVISED. SURGERY COMPLETED SUCCESSFULLY.

  Patient problems: Metal Related Pathology

  MAUDE report 23434015 ↗
• InjuryJan 4, 2023Device Appears to Trigger Rejection; Device Appears to Trigger Rejection

  AT ABOUT 1 WEEK AFTER THE PRIMARY, THE PATIENT CAME IN DUE TO SIGNS OF AN INFECTION AND THE PATHOGEN IS UNKNOWN. THE SURGEON PERFORMED A WASHOUT, REVISED THE HEAD AND BIPOLAR HEAD AND THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: Medical device site infection

  MAUDE report 16094458 ↗
• InjurySep 26, 2019Loosening of Implant Not Related to Bone-Ingrowth

  REVISION SURGERY PERFORMED AFTER 6 YEARS FROM THE PREVIOUS REVISION SURGERY (PERFORMED IN 2013 EXACT DATE UNKNOWN), DUE TO LUXATION OF THE HEAD FORM THE CUP LINER (THE LINER INVOLVED IS NOT MARKETED IN THE USA). THE SURGEON REVISED THE HEAD AND THE LINER.

  Patient problems: Joint Dislocation

  MAUDE report 9122743 ↗
• InjuryAug 22, 2019Appropriate Device Problem Term/Code Not Available

  THE PATIENT CAME IN DUE TO SIGNS OF AN INFECTION AND THE PATHOGEN IS UNKNOWN. THE SURGEON PERFORMED AN I&D AND REVISED THE 28MM COCR HEAD L WITH A 28MM COCR HEAD L AND REVISED THE BIPOLAR HEAD 51MM/28 WITH A BIPOLAR HEAD 51MM/28 1 MONTH AFTER PRIMARY. THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: Unspecified Infection

  MAUDE report 8919936 ↗
• InjuryOct 6, 2017Appropriate Device Problem Term/Code Not Available

  THE PATIENT CAME IN DUE TO SIGNS OF INFECTION. THE SURGEON REVISED THE HEAD.THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: Unspecified Infection

  MAUDE report 6921489 ↗

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