CoCr Femoral Ball Head 01.25.014Recalls & reported problems

Summary

The FDA's MAUDE database contains 11 adverse event reports that list this exact device (DI 07630030805134), received between Apr 27, 2018 and Jul 10, 2026 — classified as 10 injuries, 1 malfunction.

The most frequently reported specific device problem is “Device Appears to Trigger Rejection” (3 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.

• InjuryJul 10, 2026Device Appears to Trigger Rejection

  REVISION SURGERY DUE TO INFECTION AFTER 26 DAYS FROM PRIMARY. THE SURGEON PERFORMED A WASHOUT AND REVISED THE 12/14 D 28 MM SIZE XL COCR HEAD TO A SAME SIZE HEAD, AND REVISED THE DOUBLE MOBILITY HC LINER D 28/DME TO A SAME SIZE LINER.

  Patient problems: Medical device site infection

  MAUDE report 25778112 ↗
• InjurySep 2, 2025Device Appears to Trigger Rejection; Device Appears to Trigger Rejection

  AT ABOUT 2 WEEKS FROM 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 22937397 ↗
• InjuryMay 6, 2024Device Appears to Trigger Rejection; Device Appears to Trigger Rejection

  THE PATIENT UNDERWENT PRIMARY SURGERY ON (B)(6) 2022. ON (B)(6) 2022, THE PATIENT HAS BEEN REVISED THE FIRST TIME BECAUSE OF SURGICAL WOUND ISSUES. CERAMIC BALL HEAD Ø36 SIZE XL AND LINER Ø36/E REVISED SUCCESSFULLY AND THE SURGEON IMPLANTED CERAMIC BALL HEAD (Ø36 SIZE XL) AND PE LINER. ON (B)(6) 2022, THE PATIENT UNDERWENT A SECOND REVISION SURGERY DUE TO JOINT LUXATION. BALL HEAD, LINER AND ACETABULAR SHELL HAVE BEEN SUCCESSFULLY REVISED AND VERSAFITCUP DM Ø58MM, LINER DM Ø28/58MM DMI AND COCR BALL HEAD Ø28 SIZE XL (+7) WERE IMPLANTED. ON (B)(6) 2022, THE PATIENT HAS BEEN REVISED BECAUSE OF INFECTION AND THE SURGEON PERFORMED A WASHOUT WITH REVISION OF MOBILE PARTS OF THE PROSTHESIS.

  Patient problems: Unspecified Infection

  MAUDE report 19249219 ↗
• InjurySep 14, 2021Unstable; Appropriate Device Problem Term/Code Not Available

  5 YEARS AND 7 MONTHS AFTER THE PRIMARY THE PATIENT CAME IN REPORTING INSTABILITY DUE TO A LEG LENGTH DISCREPANCY AND THE CAUSE OF THE LEG LENGTH DISCREPANCY IS UNKNOWN. THE SURGEON REVISED THE STEM AND HEAD WITH COMPETITOR COMPONENTS AND REVISED THE MEDACTA LINER WITH A MEDACTA LINER. THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: Insufficient Information

  MAUDE report 12466363 ↗
• InjuryJan 12, 2021Appropriate Device Problem Term/Code Not Available

  THE PATIENT CAME IN AFTER 8 YEARS AND 6 MONTHS FROM THE PRIMARY SURGERY REPORTING PAIN AND WAS DIAGNOSED WITH TRUNNIONOSIS(THE CAUSE IN UNKNOWN). THE SURGEON REVISED THE HEAD AND LINER AND THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: Pain

  MAUDE report 11153622 ↗
• InjuryNov 24, 2020Adverse Event Without Identified Device or Use Problem

  THE PATIENT CAME IN AFTER 11 YEARS AND 3 MONTHS FROM THE PRIMARY SURGERY REPORTING PAIN AND THE CAUSE OF THE PAIN IS UNKNOWN. THE SURGEON REVISED THE CUP, LINER, AND HEAD. THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: Pain

  MAUDE report 10895757 ↗
• InjuryNov 24, 2020Loose or Intermittent Connection

  THE PATIENT CAME IN AFTER 6 YEARS AND 9 MONTHS FROM THE PRIMARY SURGERY REPORTING PAIN DUE TO A SUBSIDED STEM. THE CAUSE OF THE SUBSIDED STEM IS UNKNOWN. THE SURGEON REVISED THE LINER AND STEM AND THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: Pain

  MAUDE report 10895621 ↗
• InjuryJul 15, 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 10275101 ↗
• MalfunctionJul 26, 2018Device Contamination with Chemical or Other Material

  A BLACK SIGN WAS FOUND IN THE INTERNAL PART OF THE COCR BALL HEAD, A CERAMIC HEAD WAS USED TO COMPLETE THE SURGERY. IN ADDITION, THE SURGEON SUGGESTED TO MODIFY THE PICTURE ON THE IMPLANT LABEL; IT IS WITHOUT THE COLLAR WHILE THE IMPLANT HAS IT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7722405 ↗
• InjuryMay 17, 2018Adverse Event Without Identified Device or Use Problem

  REVISION SURGERY DUE TO SIGNS OF INFECTION AFTER 2 MONTHS. THE PATHOGEN IS UNKNOWN. THE SURGEON REVISED THE HEAD AND LINER.

  Patient problems: Unspecified Infection

  MAUDE report 7522290 ↗
• InjuryApr 27, 2018Appropriate Device Problem Term/Code Not Available

  REVISION SURGERY PERFORMED DUE TO HEMATOMA 3 MONTHS AFTER PRIMARY. THE SURGEON REVISED THE BIPOLAR HEAD AND THE FEMORAL HEAD.

  Patient problems: Hematoma

  MAUDE report 7468210 ↗

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