CoCr Femoral Ball Head 01.25.015Recalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 07630030805141), received between Jul 12, 2017 and Oct 6, 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 6, 2025Device Dislodged or Dislocated; Device Dislodged or Dislocated

  THE PATIENT HAD A PRIMARY HIP SURGERY ON 18 DEC 2019. SUBSEQUENTLY, THE HEAD DISLOCATED FROM THE LINER. ON (B)(6) 2022, THE SURGEON REVISED THE HEAD AND LINER. (B)(4). SUBSEQUENTLY, THE PATIENT CAME IN DUE TO SIGNS OF INFECTION AND THE PATHOGEN WAS UNKNOWN. ON (B)(6) 2022, THE SURGEON PERFORMED A WASHOUT AND REVISED THE HEAD AND LINER. (B)(4). SUBSEQUENTLY, THE PATIENT CAME IN DUE TO SIGNS OF INFECTION AND THE PATHOGEN WAS UNKNOWN. ON (B)(6) 2023, THE SURGEON PERFORMED A WASHOUT, REVISED ALL IMPLANTS. (B)(4). SUBSEQUENTLY, THE PATIENT CAME IN DUE TO SIGNS OF INFECTION AND THE PATHOGEN WAS UNKNOWN. ON 28 AUG 2023, THE SURGEON PERFORMED A WASHOUT, REVISED ALL IMPLANTS. (B)(4). SUBSEQUENTLY, THE PATIENT CAME IN DUE TO A DISLOCATION OF THE HEAD FROM THE LINER. ON (B)(6) 2023, THE SURGEON REVISED THE HEAD AND LINER AND IMPLANTED A DM CONVERTER. (B)(4). ON (B)(6) 2025, THE PATIENT CAME IN REPORTING PAIN DUE TO A DISLOCATION OF THE HEAD FROM THE LINER AND THE CAUSE IS UNKNOWN. ON (B)(6) 2025 THE SURGEON REVISED THE MEDACTA STEM WITH A COMPETITOR STEM, AND REVISED THE MEDACTA HEAD AND LINER TO A MEDACTA DM.

  Patient problems: Joint Dislocation

  MAUDE report 23221255 ↗
• InjuryJan 24, 2025Device Appears to Trigger Rejection; Device Appears to Trigger Rejection

  THE PATIENT HAD A PRIMARY HIP SURGERY ON (B)(6) 2024. ON (B)(6) 2024, THE PATIENT CAME IN REPORTING PAIN DUE TO A DISLOCATION OF THE HEAD FROM THE LINER AND THE CAUSE WAS UNKNOWN. THE SURGEON REVISED HEAD, LINER AND DM CONVERTER. THE SURGERY WAS COMPLETED SUCCESSFULLY. MDR 3005180920-2024-01131. ON (B)(6) 2025 THE PATIENT CAME IN DUE TO SIGNS OF AN INFECTION AND THE PATHOGEN IS UNKNOWN. THE SURGEON PERFORMED A WASHOUT AND REVISED THE HEAD, LINER AND DM CONVERTER. THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: Unspecified Infection

  MAUDE report 21227335 ↗
• InjuryAug 8, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  AT ABOUT 8 MONTHS AFTER THE PRIMARY, THE PATIENT CAME IN REPORTING PAIN AND THE CAUSE OF PAIN IS UNKNOWN. THE SURGEON REVISED THE DM LINER WITH AN OFFSET LINER, AND REVISED THE COCR HEAD WITH A BIOLOX HEAD. THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: Pain

  MAUDE report 19936759 ↗
• InjuryDec 21, 2023Device Appears to Trigger Rejection; Device Appears to Trigger Rejection

  THE PATIENT HAD A PRIMARY HIP SURGERY ON 18 DEC 2019. SUBSEQUENTLY, THE HEAD DISLOCATED FROM THE LINER. ON (B)(6) 2022, THE SURGEON REVISED THE HEAD AND LINER. SUBSEQUENTLY, THE PATIENT CAME IN DUE TO SIGNS OF INFECTION AND THE PATHOGEN WAS UNKNOWN. ON (B)(6) 2022, THE SURGEON PERFORMED A WASHOUT AND REVISED THE HEAD AND LINER. SUBSEQUENTLY, THE PATIENT CAME IN DUE TO SIGNS OF INFECTION AND THE PATHOGEN WAS UNKNOWN. ON (B)(6) 2023, THE SURGEON PERFORMED A WASHOUT, REVISED ALL IMPLANTS. SUBSEQUENTLY, THE PATIENT CAME IN SUE TO SIGNS OF INFECTION AND THE PATHOGEN WAS UNKNOWN. ON (B)(6) 2023, THE SURGEON PERFORMED A WASHOUT, REVISED ALL IMPLANTS. SUBSEQUENTLY, THE PATIENT CAME IN DUE TO A DISLOCATION OF THE HEAD FROM THE LINER. ON (B)(6) 2023, THE SURGEON REVISED THE HEAD AND LINER AND IMPLANTED A DM CONVERTER. PRESENTLY, THE PATIENT CAME IN DUE TO SIGNS OF INFECTION AND THE PATHOGEN IS UNKNOWN. THE SURGEON PERFORMED A WASHOUT AND REVISED THE HEAD, LINER AND DM CONVERTER. THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: Unspecified Infection

  MAUDE report 18371294 ↗
• InjuryJul 12, 2017Adverse Event Without Identified Device or Use Problem

  THE PATIENT CAME IN COMPLAINING OF PAIN. THE CAUSE OF THE PAIN IS UNKNOWN. THE SURGEON REVISED THE HEAD AND LINER. THE SURGERY WAS COMPLETED SUCCESSFULLY. X-RAYS ARE AVAILABLE; EXPLANTS ARE AVAILABLE.

  Patient problems: Pain

  MAUDE report 6705102 ↗

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