CoCr Femoral Ball Head 01.25.033Recalls & reported problems
Medacta International SA · Femoral Head Ø 36 size XL · Class 2 · Implant
All models of CoCr Femoral Ball Head (15)
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 2
- Deaths reported
- 0
- Injuries reported
- 2
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 07630030805233), received between Sep 27, 2024 and Jan 16, 2025 — classified as 2 injuries.
The most frequently reported specific device problem is “Device Dislodged or Dislocated” (2 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.
Reports received per month
Most reported problems
Device problems
- Device Dislodged or Dislocated2
Patient problems
- Implant Pain2
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
InjuryJan 16, 2025Device Dislodged or Dislocated; Device Dislodged or Dislocated
THE PATIENT HAD A PRIMARY HIP SURGERY WITH A COMPETITOR ON AN UNKNOWN DATE. SUBSEQUENTLY, THE PATIENT CAME IN FOR AN UNKNOWN REASON AND THE SURGEON REVISED THE COMPETITOR HEAD TO A MEDACTA HEAD ON (B)(6) 2024. ON (B)(6) 2024 THE PATIENT HAD PAIN DUE TO A DISLOCATION OF THE MEDACTA HEAD FROM THE COMPETITOR LINER. THE SURGEON REVISED THE MEDACTA HEAD WITH ANOTHER MEDACTA HEAD AND REVISED THE COMPETITOR LINER WITH ANOTHER COMPETITOR LINER. THE SURGERY WAS COMPLETED SUCCESSFULLY.
Patient problems: Implant Pain
MAUDE report 21166549 ↗InjurySep 27, 2024Device Dislodged or Dislocated; Device Dislodged or Dislocated
THE PATIENT HAD A PRIMARY ON (B)(6) 2024. ON (B)(6) 2024 DUE TO A FALL AND DISLOCATION, THE HEAD WAS REVISED TO ANOTHER MEDACTA HEAD. ON (B)(6) 2024 THE PATIENT WAS REVISED FOR A DISLOCATION AND THE CAUSE IS UNKNOWN. THE SURGEON REVISED THE HEAD, CUP AND LINER. THE SURGERY WAS COMPLETED SUCCESSFULLY.
Patient problems: Implant Pain
MAUDE report 20320102 ↗
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Sources and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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