CoCr Femoral Ball Head 01.25.011Recalls & reported problems

Summary

The FDA's MAUDE database contains 10 adverse event reports that list this exact device (DI 07630030805103), received between Oct 6, 2017 and Jan 18, 2024 — classified as 10 injuries.

The most frequently reported specific device problem is “Device Dislodged or Dislocated” (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 10 most recent of 10 reports, in the reporter's own words as published by the FDA.

• InjuryJan 18, 2024Device Dislodged or Dislocated; Device Dislodged or Dislocated

  AT ABOUT 2 WEEKS AFTER PRIMARY, THE PATIENT CAME IN REPORTING PAIN DUE TO A DISLOCATION OF THE BIPOLAR HEAD FROM THE ACETABULUM. THE SURGEON EXPLANTED THE COCR HEAD AND BIPOLAR HEAD AND CONVERTED THE PATIENT TO A TOTAL HIP. THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: Pain

  MAUDE report 18535548 ↗
• InjuryOct 4, 2023Device Appears to Trigger Rejection; Device Appears to Trigger Rejection

  THE PATIENT HAD A PRIMARY HIP SURGERY ON (B)(6) 2020. ON (B)(6) 2022, THE PATIENT CAME IN REPORTING PAIN DUE TO A DISLOCATION OF THE HEAD FROM THE LINER THAT WAS CAUSED FROM FALLING. THE SURGEON REVISED THE CUP, HEAD, AND LINER. THE SURGERY WAS COMPLETED SUCCESSFULLY. ON (B)(6) 2022, 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. (MDR 3005180920-2022-00216). PRESENTLY, ON (B)(6) 2023, 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: Unspecified Infection

  MAUDE report 17868927 ↗
• InjuryAug 5, 2022Insufficient Device Problem Information

  THE PATIENT CAME IN DUE TO SIGNS OF AN INFECTION AND THE PATHOGEN IS UNKNOWN. AT ABOUT 2 MONTHS POST PRIMARY THE SURGEON PERFORMED A WASHOUT AND REVISED THE HEAD. THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: Bacterial Infection

  MAUDE report 15174135 ↗
• InjurySep 15, 2021Device Dislodged or Dislocated

  THE PATIENT CAME IN REPORTING PAIN DUE TO A DISLOCATION OF THE HEAD FROM THE LINER AND THE CAUSE IS UNKNOWN. 1 MONTH AFTER THE PRIMARY SURGERY, THE SURGEON REVISED ALL COMPONENTS AND THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: Pain

  MAUDE report 12475408 ↗
• InjuryJul 2, 2020Appropriate Device Problem Term/Code Not Available

  THE PATIENT CAME IN REPORTING PAIN DUE TO METALLOSIS AND A LEG LENGTH DISCREPANCY. THE SURGEON PERFORMED A WASHOUT AND REVISED THE HEAD AND LINER, 7 YEARS AND 2 MONTHS AFTER PRIMARY SURGERY. THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: Joint Disorder

  MAUDE report 10223037 ↗
• InjuryAug 12, 2019Fracture; Appropriate Device Problem Term/Code Not Available

  REVISION SURGERY PERFORMED AFTER 2 MONTHS FROM THE PRIMARY DUE TO PAIN CAUSED BY FRACTURED ACETABULUM. PRIOR TO THE PRIMARY SURGERY, THE PATIENT HAD SEVERE BONE LOSS IN HER FEMORAL HEAD WHICH IN TURN CAUSED EROSION OF HER ACETABULUM. THE BIPOLAR HEAD UNDER STRESS PUSHED THROUGH THE ACETABULAR WALL. THE SURGEON REVISED BIPOLAR HEAD AND THE COCR HEAD SUCCESSFULLY.

  Patient problems: Hip Fracture

  MAUDE report 8883103 ↗
• InjuryJun 26, 2018Adverse Event Without Identified Device or Use Problem

  ABOUT 3 MONTHS AFTER PRIMARY THE SURGEON REVISED THE PATIENT FOR HIP PAIN. THE REASON OF PAIN IS UNKNOWN, ALL THE IMPLANTS WERE SWAPPED SUCCESSFULLY.

  Patient problems: Pain

  MAUDE report 7637642 ↗
• InjuryApr 20, 2018Device Dislodged or Dislocated

  DURING POST-OP X-RAYS THE HIP WAS FOUND TO BE DISLOCATED; THE PATIENT WAS REVISED ON THE SAME DAY USING A NEW HEAD. THE SURGERY WAS COMPLETED SUCCESSFULLY. THE SURGEON REPLACED THE SIZE S BALL HEAD WITH AN XL SIZE ONE. NO OTHER COMPONENT WAS REVISED.

  Patient problems: Joint Dislocation

  MAUDE report 7446810 ↗
• InjuryMar 29, 2018Adverse Event Without Identified Device or Use Problem

  THE PATIENT CAME IN DUE TO SIGNS OF INFECTION 2 WEEKS AFTER PRIMARY. THE PATHOGEN IS UNKNOWN. THE SURGEON REVISED THE BIPOLAR HEAD AND THE COCR HEAD. THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: Unspecified Infection

  MAUDE report 7380665 ↗
• InjuryOct 6, 2017Appropriate Device Problem Term/Code Not Available

  THE PATIENT HAD DISLOCATED TWICE SINCE HER PRIMARY SURGERY. HEAD, LINER AND CUP WERE REMOVED. FINAL REDUCTION WAS ACHIEVED AND PROVIDED GOOD STABILITY. THE HEAD DISLOCATED FROM THE LINER. THE REVISION SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: Joint Dislocation

  MAUDE report 6921430 ↗

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