CoCr Femoral Ball Head 01.25.012Recalls & reported problems

Summary

The FDA's MAUDE database contains 19 adverse event reports that list this exact device (DI 07630030805110), received between Sep 1, 2017 and Mar 10, 2026 — classified as 19 injuries.

The most frequently reported specific device problem is “Device Appears to Trigger Rejection” (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 19 most recent of 19 reports, in the reporter's own words as published by the FDA.

• InjuryMar 10, 2026Device Appears to Trigger Rejection

  AT ABOUT 2 MONTH FROM THE PRIMARY, THE PATIENT CAME IN DUE TO SIGNS OF INFECTION AND THE PATHOGEN IS UNKNOWN. THE SURGEON PERFORMED A WASHOUT, REVISED THE D 28MM COCR SIZE M HEAD TO A D 28MM COCR SIZE L AT THE SURGEON`S DISCRETION, AND REVISED THE D 28X53 BIOPOLAR HEAD TO A BIOPOLAR HEAD OF THE SAME SIZE. THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: Medical device site infection

  MAUDE report 24558202 ↗
• InjurySep 6, 2024Device Appears to Trigger Rejection; Device Appears to Trigger Rejection

  AT 2 MONTHS FROM THE PRIMARY, THE PATIENT CAME IN DUE TO SIGNS OF INFECTION AND THE PATHOGEN IS UNKNOWN. THE SURGEON REVISED THE MEDACTA COCR, BIPOLAR HEAD AND STEM AND REVISED THE COMPETITOR CUP AND LINER. THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: Medical device site infection

  MAUDE report 20157866 ↗
• InjuryJul 1, 2024Device 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 AFTER THE PRIMARY SURGERY, THE SURGEON PERFORMED A WASHOUT AND REVISED THE HEAD AND BIPOLAR HEAD. THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: Medical device site infection

  MAUDE report 19641799 ↗
• InjurySep 12, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  AT ABOUT 5 YEARS AND 1 MONTH AFTER PRIMARY, THE PATIENT CAME IN DUE TO SIGNS OF AN INFECTION AND THE PATHOGEN IS UNKNOWN. THE SURGEON PERFORMED A WASHOUT AND REVISED THE HEAD AND LINER. THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: Medical device site infection

  MAUDE report 17728636 ↗
• InjuryMay 30, 2023Device Appears to Trigger Rejection; Device Appears to Trigger Rejection

  AT ABOUT 12 DAYS AFTER THE PRIMARY, THE PATIENT CAME IN DUE TO SIGNS OF INFECTION AND THE PATHOGEN IS UNKNOWN. THE SURGEON PERFORMED A WASHOUT AND REVISED THE HEAD AND BIPOLAR HEAD. THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: Medical device site infection

  MAUDE report 17020054 ↗
• InjuryApr 14, 2023Device Appears to Trigger Rejection; Device Appears to Trigger Rejection

  THE PATIENT HAD A PRIMARY HIP SURGERY ON (B)(6) 2022. ON (B)(6) 2022, THE PATIENT CAME IN REPORTING PAIN DUE TO A PERIPROSTHETIC FRACTURE AND THE CAUSE IS UNKNOWN. THE SURGEON CABLED THE FRACTURE AND REVISED SUCCESSFULLY THE STEM, HEAD, AND LINER. ON (B)(6) 2022, THE PATIENT CAME IN REPORTING PAIN DUE TO DEVELOPING A HEMATOMA AND THE CAUSE IS UNKNOWN. THE SURGEON REVISED THE HEAD AND LINER. PRESENTLY, ON (B)(6) 2023, THE PATIENT CAME IN DUE TO SIGNS OF AN INFECTION AND THE PATHOGEN IS UNKNOWN. THE SURGEON REVISED THE MEDACTA STEM AND HEAD WITH A NEW MEDACTA STEM AND HEAD AND REVISED THE MEDACTA CUP AND LINER WITH A COMPETITOR CUP AND LINER. THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: Unspecified Infection

  MAUDE report 16741312 ↗
• InjurySep 12, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PATIENT HAD A TUMOR AND THE SURGEON DECIDED TO CHANGE THE HEAD AND LINER 12 YEARS 6 MONTHS AFTER THE PRIMARY FOR REASONS UNKNOWN. THERE WERE NO ISSUES WITH ANY PRODUCT. THE SURGERY WAS COMPLETED SUCCESSFULLY.

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

  MAUDE report 15402292 ↗
• InjuryJun 14, 2022Appropriate Device Problem Term/Code Not Available

  AT 2 YEARS AND 9 MONTHS AFTER THE PRIMARY, THE PATIENT CAME IN REPORTING PAIN AND THE CAUSE IS UNKNOWN. THE SURGEON REVISED MEDACTA COCR HEAD AND BIPOLAR HEAD. THE SURGEON IMPLANTED A COMPETITOR CUP AND LINER AND A MEDACTA HEAD AND SLEEVE. THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: Pain

  MAUDE report 14683542 ↗
• InjuryMar 21, 2022Appropriate Device Problem Term/Code Not Available

  REVISION SURGERY WAS PERFORMED DUE TO INFECTION 2 YEARS 2 MONTHS AFTER THE PRIMARY SURGERY. ALL IMPLANTS WERE REMOVED AND REVISED.

  Patient problems: Unspecified Infection

  MAUDE report 13839894 ↗
• InjuryFeb 3, 2021Adverse Event Without Identified Device or Use Problem

  REVISION SURGERY DUE TO INFECTION 10 YEARS 7 MONTHS AFTER THE PRIMARY AND THE PATHOGEN IS UNKNOWN. THE SURGEON REVISED THE HEAD AND LINER AND THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: Unspecified Infection

  MAUDE report 11271432 ↗
• InjuryAug 27, 2020Device Dislodged or Dislocated; Appropriate Device Problem Term/Code Not Available

  THE PATIENT CAME IN REPORTING PAIN DUE TO A DISLOCATION OF THE BALL HEAD FROM BIPOLAR HEAD. THE CAUSE OF THE DISLOCATION IS UNKNOWN, IT HAPPENED 2 YEARS AND 2 MONTHS AFTER PRIMARY. THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: Joint Dislocation

  MAUDE report 10459904 ↗
• InjuryJul 24, 2020Appropriate Device Problem Term/Code Not Available

  THE PATIENT CAME IN REPORTING PAIN AND THE CAUSE OF THE PAIN IS UNKNOWN. THE SURGEON REVISED THE STEM, HEAD, AND LINER 5 MONTHS AFTER PRIMARY. THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: Pain

  MAUDE report 10319327 ↗
• InjuryJul 22, 2020Appropriate Device Problem Term/Code Not Available

  THE PATIENT CAME IN REPORTING PAIN AND THE CAUSE OF THE PAIN IS UNKNOWN. 5 MONTHS AFTER PRIMARY THE SURGEON REVISED THE STEM, HEAD, AND LINER. THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: Pain

  MAUDE report 10306837 ↗
• InjuryJul 13, 2020Appropriate Device Problem Term/Code Not Available

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

  Patient problems: Unspecified Infection

  MAUDE report 10264555 ↗
• InjuryMay 17, 2019Adverse Event Without Identified Device or Use Problem

  REVISION SURGERY PERFORMED AFTER 2 MONTHS AND 18 DAYS FORM THE PRIMARY DUE TO SIGNS OF INFECTION AND THE PATHOGEN IS UNKNOWN. THE SURGEON PERFORMED A WASHOUT AND REVISED THE COCR HEAD AND THE BIPOLAR HEAD. THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: Unspecified Infection

  MAUDE report 8619675 ↗
• InjuryNov 9, 2018Device Slipped

  REVISION SURGERY PERFORMED, 1 MONTH AFTER PRIMARY SURGERY, DUE TO HIP LUXATION. LUXATION FROM THE HEAD TO THE LINER.

  Patient problems: No Code Available

  MAUDE report 8054894 ↗
• InjuryMay 24, 2018Appropriate Device Problem Term/Code Not Available

  REVISION DUE TO SIGNS OF INFECTION 2 WEEKS AFTER PRIMARY. THE PATHOGEN IS UNKNOWN. THE SURGEON REVISED THE HEAD AND LINER SUCCESSFULLY.

  Patient problems: Unspecified Infection

  MAUDE report 7540695 ↗
• InjuryJan 19, 2018Adverse Event Without Identified Device or Use Problem

  THE PATIENT CAME IN DUE TO SIGNS OF INFECTION. THE PATHOGEN IS UNKNOWN. THE SURGEON REVISED THE HEAD AND LINER. THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: Unspecified Infection

  MAUDE report 7206119 ↗
• InjurySep 1, 2017Appropriate Device Problem Term/Code Not Available

  REVISION SURGERY PERFORMED DUE TO LIMITED RANGE OF MOTION AND GREATER TROCHANTER FRACTURE. THE FRACTURE WAS TREATED WITH THREE TROCHANTERIC PLATES IN ORDER TO FIX IT INTERNALLY. THE MEDACTA HEAD WAS REPLACED. THE INLAY WAS CHANGED AS WELL BUT IT WAS ANON- MEDACTA PRODUCT. THE SURGEON STATED THAT NO EXCESSIVE SIGNS OF WEAR OR DEBRIS WERE VISIBLE.

  Patient problems: Bone Fracture(s); Joint Disorder

  MAUDE report 6837595 ↗

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