CoCr Femoral Ball Head 01.25.031Recalls & reported problems

Summary

The FDA's MAUDE database contains 16 adverse event reports that list this exact device (DI 07630030805219), received between Oct 6, 2017 and Apr 14, 2026 — classified as 16 injuries.

The most frequently reported specific device problem is “Device Dislodged or Dislocated” (9 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 16 most recent of 16 reports, in the reporter's own words as published by the FDA.

• InjuryApr 14, 2026Adverse Event Without Identified Device or Use Problem

  AT ABOUT (B)(6) AFTER THE PRIMARY, THE PATIENT CAME IN PRESENTING INSTABILITY DUE TO A GAP FORMING BETWEEN THE HEAD AND LINER. THE CAUSE IS UNKNOWN AS THERE WAS NO REPORTED TRAUMA. THE SURGEON REVISED THE MEDACTA CUP AND LINER TO A COMPETITOR CUP AND LINER AND REVISED THE MEDACTA 36MM HEAD TO A 28MM HEAD WITH SLEEVE. THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: Joint Laxity

  MAUDE report 24871649 ↗
• InjuryFeb 6, 2026Loosening of Implant Not Related to Bone-Ingrowth

  AT ABOUT 10 YEARS 5 MONTHS AFTER THE PRIMARY, THE PATIENT CAME IN REPORTING PAIN DUE TO METALLOSIS. THE SURGEON ALSO OBSERVED THAT THE CUP WAS LOOSE. THE SURGEON REVISED THE CUP, LINER, AND HEAD. THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: Aseptic loosening; Metal Related Pathology

  MAUDE report 24276574 ↗
• InjuryDec 23, 2025Device Appears to Trigger Rejection; Device Appears to Trigger Rejection

  AT ABOUT 1 MONTH FROM 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 LINER. THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: Medical device site infection

  MAUDE report 23876943 ↗
• InjuryJul 23, 2025Device Dislodged or Dislocated; Device Dislodged or Dislocated

  AT ABOUT 3 MONTHS FROM THE PRIMARY SURGERY, THE PATIENT CAME IN REPORTING PAIN DUE TO A DISLOCATION OF THE MEDACTA HEAD FROM THE COMPETITOR LINER. THE SURGEON REVISED AND UPSIZED ONLY THE HEAD TO GIVE THE PATIENT STABILITY TO DETER RECURRING DISLOCATIONS. THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: Joint Dislocation; Pain

  MAUDE report 22573682 ↗
• InjuryNov 18, 2024Device Dislodged or Dislocated; Device Dislodged or Dislocated

  AT ABOUT 5 YEARS AND 11 MONTHS AFTER PRIMARY, THE PATIENT CAME IN REPORTING INSTABILITY AND THE CAUSE IS UNKNOWN. THE SURGEON REVISED THE STEM, HEAD AND LINER. THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: Joint Dislocation

  MAUDE report 20705340 ↗
• InjuryDec 21, 2023Device Dislodged or Dislocated; Device Dislodged or Dislocated

  REVISION 1 MONTH AND A HALF AFTER THE PRIMARY DUE TO JOINT LUXATION (LINER IS FROM A COMPETITOR). THE MEDACTA HEAD WAS REVISED SUCCESSFULLY.

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

  MAUDE report 18371302 ↗
• InjuryNov 16, 2023Device Appears to Trigger Rejection; Device Appears to Trigger Rejection

  REVISION SURGERY AT ABOUT 3 MONTHS POST PRIMARY DUE TO HIP INFECTION. THE SURGEON REVISED THE STEM AND HEAD FROM MEDACTA AND THE ACETABULAR COMPONENTS FROM COMPETITOR. CEMENT SPACER WAS IMPLANTED SUCCESSFULLY.

  Patient problems: Unspecified Infection

  MAUDE report 18148911 ↗
• InjuryJun 1, 2023Device Appears to Trigger Rejection; Device Appears to Trigger Rejection

  AT ABOUT 1 YEAR AND 11 MONTHS AFTER THE PRIMARY SURGERY, THE PATIENT CAME IN REPORTING PAIN AND THE CAUSE IS UNKNOWN. THE SURGEON REVISED ALL COMPONENTS AND THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: Medical device site infection

  MAUDE report 17038546 ↗
• InjuryMar 13, 2023Device Dislodged or Dislocated; Device Dislodged or Dislocated

  REVISION SURGERY PERFORMED AT ABOUT 8 MONTHS AFTER PRIMARY DUE TO JOINT LUXATION (HEAD FROM LINER). THE SURGEON REVISED SUCCESSFULLY THE HEAD AND LINER.

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

  MAUDE report 16529554 ↗
• InjuryNov 30, 2021Device Dislodged or Dislocated

  THE PATIENT CAME IN 3 DAYS AFTER THE PRIMARY SURGERY REPORTING PAIN DUE TO A DISLOCATION OF THE HEAD FROM THE LINER. THE SURGEON REVISED THE CUP, HEAD, AND LINER. THE SURGERY WAS COMPLETED SUCCESSFULLY. THE SURGEON IMPLANTED A LARGER DM CUP WITH MORE ANTEVERSION PUT IN.

  Patient problems: Joint Dislocation

  MAUDE report 12890288 ↗
• InjuryJun 7, 2021Device Dislodged or Dislocated; Appropriate Device Problem Term/Code Not Available

  1 MONTH AFTER THE PRIMARY SURGERY THE PATIENT CAME IN REPORTING PAIN DUE TO A DISLOCATION OF THE HEAD FROM THE LINER DUE TO A LENGTH DISCREPANCY. THE CAUSE OF THE LEG LENGTH DISCREPANCY IS UNKNOWN. THE SURGEON REVISED THE 36MM COCR HEAD M WITH A 36MM COCR HEAD XL. THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: Joint Dislocation

  MAUDE report 11946155 ↗
• InjuryJan 15, 2021Device Dislodged or Dislocated

  THE PATIENT CAME IN, 2 MONTHS AFTER PRIMARY SURGERY, REPORTING PAIN DUE TO A DISLOCATION OF THE HEAD FROM THE LINER. THE SURGEON REVISED THE MEDACTA HEAD WITH A MEDACTA HEAD AND REVISED THE MEDACTA LINER AND CUP WITH ANOTHER COMPANY'S PRODUCT. THE SURGERY WAS COMPLETED SUCCESSFULLY. A DIRECT ANTERIOR APPROACH WAS USED IN THE PRIMARY SURGERY.

  Patient problems: Joint Dislocation

  MAUDE report 11176900 ↗
• InjuryOct 20, 2020Device Dislodged or Dislocated

  AFTER THE PRIMARY HIP SURGERY, WHEN THE PATIENT WAS BEING TRANSFERRED TO ANOTHER BED, THE PATIENT'S HIP DISLOCATED (THE HEAD DISLOCATED FROM THE LINER). ONE DAY AFTER THE PRIMARY SURGERY, THE SURGEON REVISED THE MASTERLOC CEMENTLESS MECTAGRIP STEM STD #7 WITH A MASTERLOC CEMENTLESS MECTAGRIP STEM LAT PLUS #7 AND THE 36MM COCR HEAD M WITH A 36MM COCR HEAD XL. THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: Joint Dislocation

  MAUDE report 10705416 ↗
• InjuryNov 14, 2018Adverse Event Without Identified Device or Use Problem

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

  Patient problems: Unspecified Infection

  MAUDE report 8069022 ↗
• InjuryOct 26, 2017Device Dislodged or Dislocated

  THE PATIENT CAME IN COMPLAINING OF PAIN. THE PATIENT HAD DISLOCATED. NO TRAUMA REPORTED. THE SURGEON SWAPPED THE HEAD AND LINER. THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: Joint Dislocation; Pain

  MAUDE report 6979311 ↗
• InjuryOct 6, 2017Adverse Event Without Identified Device or Use Problem

  THE PATIENT CAME IN AND PRESENTED WITH A HEMATOMA. THE SURGEON WASHED OUT THE HIP AND REVISED THE HEAD. THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: Hematoma

  MAUDE report 6921441 ↗