CoCr Femoral Ball Head 01.25.123Recalls & reported problems

Summary

The FDA's MAUDE database contains 11 adverse event reports that list this exact device (DI 07630030805479), received between Oct 26, 2018 and Mar 3, 2026 — classified as 11 injuries.

The most frequently reported specific device problem is “Device Dislodged or Dislocated” (4 reports).

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.

• InjuryMar 3, 2026Device Dislodged or Dislocated

  REVISION SURGERY WAS PERFORMED DUE TO INSTABILITY AND DISLOCATION. AT ABOUT 6 MONTHS FROM PRIMARY THE SURGEON REVISED THE HEAD TO ONE OF COMPETITOR.

  Patient problems: Joint Dislocation

  MAUDE report 24494919 ↗
• InjuryDec 18, 2025Device Dislodged or Dislocated; Device Dislodged or Dislocated

  THE PATIENT HAD PRIMARY LEFT HIP SURGERY ON (B)(6) 2016. ON (B)(6) 2024, THE PATIENT CAME IN REPORTING PAIN DUE TO A DISLOCATION OF THE HEAD FROM THE LINER AND THE CAUSE IS UNKNOWN. THE SURGEON REVISED THE HEAD AND LINER. THE SURGERY WAS COMPLETED SUCCESSFULLY. 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. THE SURGEON REVISED THE BIOLOX HEAD AND HOODED LINER TO A COCR HEAD AND CONTRAINED LINER. THE SURGERY WAS COMPLETED SUCCESSFULLY. PRESENTLY, ON (B)(6) 2025, THE PATIENT CAME IN DUE TO INTRA-PROSTHETIC DISLOCATION, WHERE THE COCR HEAD HAD DISENGAGED FROM THE BIPOLAR COMPONENT. THE SURGEON REPORTED THAT DURING THE INITIAL IMPLANTATION, THERE WAS NO CLEAR TACTILE FEEDBACK OR CONFIRMATION OF FULL ENGAGEMENT, AND HE HAD NOTICED THE HEAD APPEARING SLIGHTLY DISPLACED FROM THE BIPOLAR COMPONENT. THE CONSTRAINED LINER AND METAL HEAD WERE REMOVED AND REPLACED WITH AN OFFSET D LINER AND A CERAMIC HEAD. THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: Joint Dislocation

  MAUDE report 23837281 ↗
• InjuryOct 31, 2024Device Appears to Trigger Rejection; Device Appears to Trigger Rejection

  AT ABOUT 6 MONTHS AFTER PRIMARY, THE PATIENT CAME IN DUE TO SIGNS OF INFECTION AND THE PATHOGEN IS UNKNOWN. THE SURGEON REVISED SUCCESSFULLY THE CUP, HEAD AND LINER.

  Patient problems: Medical device site infection

  MAUDE report 20576414 ↗
• InjuryJun 23, 2023Device Appears to Trigger Rejection; Device Appears to Trigger Rejection

  AT ABOUT 1 MONTH 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, LINER AND DM CONVERTER. THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: Unspecified Infection

  MAUDE report 17194743 ↗
• InjuryApr 21, 2022Appropriate Device Problem Term/Code Not Available

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

  Patient problems: Unspecified Infection

  MAUDE report 14165804 ↗
• InjuryMar 9, 2022Device Dislodged or Dislocated; Appropriate Device Problem Term/Code Not Available

  REVISION SURGERY AT ABOUT 2 MONTHS FROM PRIMARY DUE TO INTRAPROSTATIC DISLOCATION OF THE METAL HEAD FROM THE DOUBLE MOBILITY LINER. THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: Insufficient Information

  MAUDE report 13711507 ↗
• InjuryNov 22, 2021Adverse Event Without Identified Device or Use Problem

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

  Patient problems: Unspecified Infection

  MAUDE report 12851085 ↗
• InjuryJan 18, 2019Device Dislodged or Dislocated

  THE PATIENT CAME IN, 5 WEEKS AFTER PRIMARY SURGERY, DUE TO A DISLOCATION OF THE BIPOLAR HEAD FROM THE ACETABULUM. THE SURGEON CONVERTED THE BIPOLAR HIP TO A TOTAL HIP AND REVISED THE STEM, COCR HEAD AND BIPOLAR HEAD. THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8260596 ↗
• InjuryJan 10, 2019Adverse Event Without Identified Device or Use Problem

  THE PATIENT CAME IN, 1 MONTH AFTER PRIMARY SURGERY, 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 8235432 ↗
• InjuryNov 20, 2018Microbial Contamination of Device

  THE PATIENT CAME IN DUE TO SIGNS OF INFECTION 1 MONTH AFTER THE PRIMARY. THE PATHOGEN IS UNKNOWN AT THIS TIME. THE SURGEON PERFORMED A WASHOUT AND HEAD EXCHANGE.

  Patient problems: Unspecified Infection

  MAUDE report 8089814 ↗
• InjuryOct 26, 2018Adverse Event Without Identified Device or Use Problem

  ABOUT 1 MONTH AFTER PRIMARY THE SURGEON REVISED THE PATIENT HIP FOR AN INFECTION CASE. LINER AND HEAD SWAP. THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: Unspecified Infection

  MAUDE report 8009367 ↗