CoCr Femoral Ball Head 01.25.030Recalls & reported problems
Medacta International SA · Femoral Head Ø 36 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 07630030805202), received between May 20, 2023 and Jun 17, 2025 — classified as 3 injuries.
The most frequently reported specific device problem is “Device Appears to Trigger Rejection” (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 Appears to Trigger Rejection2
- Adverse Event Without Identified Device or Use Problem1
Patient problems
- Bone Fracture(s)1
- Joint Laxity1
- Osteolysis1
- Pain1
- Unspecified Infection1
Recent adverse event reports
The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.
InjuryJun 17, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
AT ABOUT 7 MONTHS FROM PRIMARY, THE PATIENT CAME IN REPORTING PAIN AND INSTABILITY DUE TO A LEG LENGTH DISCREPANCY AND LACK OF OFFSET. THE SURGEON REVISED THE HEAD AND LINER AND THE SURGERY WAS COMPLETED SUCCESSFULLY.
Patient problems: Joint Laxity; Pain
MAUDE report 22229294 ↗InjuryMar 27, 2024Device Appears to Trigger Rejection; Device Appears to Trigger Rejection
THE PATIENT HAD A PRIMARY HIP SURGERY ON 2023. 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 MEDACTA HEAD AND COMPETITOR LINER. THE SURGERY WAS COMPLETED SUCCESSFULLY. PRESENLTLY ON (B)(6) 2024 , THE PATIENT CAME IN DUE TO SIGNS OF AN INFECTION AND THE PATHOGEN IS UNKNOWN. THE SURGEON REMOVED ALL COMPONENTS AND IMPLANTED AN ANTIBIOTIC SPACER. THE SURGERY WAS COMPLETED SUCCESSFULLY.
Patient problems: Unspecified Infection
MAUDE report 18985245 ↗InjuryMay 20, 2023Device Appears to Trigger Rejection; Device Appears to Trigger Rejection
REVISION SURGERY PERFORMED AT ABOUT 6 YEARS AND 11 MONTHS AFTER PRIMARY DUE TO SUSPECTED TRUNNIONOSIS FROM THE COCR HEAD METAL TAPER AND OSTEOLYSIS IN THE PROXIMAL FEMUR AND AROUND THE CUP IMPLANT. MOREOVER, X-RAYS SHOW A GREATER TROCHANTER FRACTURE. THE SURGEON REVISED SUCCESSFULLY CUP, HEAD AND LINER.
Patient problems: Bone Fracture(s); Osteolysis
MAUDE report 16970519 ↗
Other Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Cemented devices
- NA 1365-51-000Depuy (Ireland) · Prosthesis, hip, semi-constrained, metal/polymer, cemented753 reports
- NA 1365-50-000Depuy (Ireland) · Prosthesis, hip, semi-constrained, metal/polymer, cemented412 reports
- ARTICUL/EZE 1365-21-000Depuy (Ireland) · Prosthesis, hip, semi-constrained, metal/polymer, cemented1 recall280 reports
- ARTICUL/EZE 1365-11-000Depuy (Ireland) · Prosthesis, hip, semi-constrained, metal/polymer, cemented1 death262 reports
- LFIT 6260-9-236Howmedica Osteonics Corp. · Prosthesis, hip, semi-constrained, metal/polymer, cemented256 reports
- 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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