CoCr Femoral Ball Head 01.25.124Recalls & reported problems
Medacta International SA · Femoral Head Ø 22 size S · 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
- 3
- Deaths reported
- 0
- Injuries reported
- 3
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 07630030805486), received between Dec 14, 2018 and Sep 16, 2022 — classified as 3 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.
Most reported problems
Device problems
- Device Dislodged or Dislocated2
- Detachment of Device or Device Component1
Patient problems
- Joint Dislocation3
Recent adverse event reports
The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.
InjurySep 16, 2022Device Dislodged or Dislocated; Device Dislodged or Dislocated
AT ABOUT 3 YEARS AND 4 MONTHS AFTER THE PRIMARY SURGERY, THE PATIENT CAME IN REPORTING PAIN DUE TO A DISLOCATION OF THE HEAD FROM THE LINER AND THE CAUSE OF THE DISLOCATION IS UNKNOWN. THE SURGEON REVISED THE HEAD AND LINER AND THE SURGERY WAS COMPLETED SUCCESSFULLY.
Patient problems: Joint Dislocation
MAUDE report 15438731 ↗InjuryJan 4, 2021Device Dislodged or Dislocated
REVISION SURGERY PERFORMED DUE TO DISLOCATION OF THE HEAD FROM THE LINER, 2 MONTHS AFTER PRIMARY SURGERY. HEAD AND LINER REVISED SUCCESSFULLY.
Patient problems: Joint Dislocation
MAUDE report 11106972 ↗InjuryDec 14, 2018Detachment of Device or Device Component
THE PATIENT CAME IN,1 MONTHS AND 9 DAYS AFTER PRIMARY SURGERY, DUE TO A DISLOCATION OF THE HEAD FROM THE ACETABULUM, ONE MONTH AFTER PRIMARY SURGERY. THE SURGEON REVISED THE BIPOLAR HEAD AND IMPLANTED A 32MM COCR HEAD, CUP AND LINER.
Patient problems: Joint Dislocation
MAUDE report 8164778 ↗
Other Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Cemented devices
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- PINNACLE GRIPTION 1217-32-052Depuy Orthopaedics, Inc. · Prosthesis, hip, semi-constrained, metal/polymer, cemented2 deaths239 reports
- ELEOS™ 25002111EOnkos Surgical, Inc. · Prosthesis, hip, semi-constrained, metal/polymer, cemented3 deaths230 reports
- Novation 130-36-52Exactech, Inc. · Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Cemented2 recalls124 reports
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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