MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA COCR FEMORAL BALL HEAD; COCR BALL HEAD 12/14 Ø32 MM SIZE S

Model Number	01.25.021
Medical Device Problem Code	Device Appears to Trigger Rejection (1524)
Health Effect - Clinical Code	Metal Related Pathology (4530)
Date of Event	11/27/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Batch review performed on 02 dec 2025.Ball heads: cocr 01.25.021 cocr ball head 12/14 d 32 mm size s lot.2422891: (b)(4) items manufactured and released on 03 feb 2025.Expiration date: 19 jan 2030.No anomalies found related to the problem.To date, (b)(4) items of the same lot have been sold with no similar reported event during the period of review.Clinical evaluation: few months after primary uncemented tha, the patient feels pain and nickel allergy is diagnosed.The only implanted component with a significant nickel content was the femoral head, which was then replaced to a ceramic device.Such a visible bone reaction after a short implantation time is certainly an indicator of a local reaction, and the diagnosis of allergy is compatible with the radiographic finding.We understand that the question about infection has been raised but not fully answered, because this is another possibility.In either case, there is no reason to suspect a problem related with the devices.Root cause: based on the available information, no definitive root cause can be established.However, the clinical and radiographic findings are consistent with a local allergic reaction.There is no indication that a device-related issue caused or contributed to the event, and the device history record review did not identify any manufacturing-related issues.
Event or Problem Description
Five months after the primary surgery, the patient reported persistent pain and swelling.A nickel allergy was diagnosed.Based on this and the x-ray findings, a revision was performed.Intraoperatively, the stem was stable, so only the head was exchanged with a biolox option.

• Brand Name: COCR FEMORAL BALL HEAD
• Common Device Name: COCR BALL HEAD 12/14 Ø32 MM SIZE S
• Manufacturer (Section D): MEDACTA INTERNATIONAL SA; strada regina; castel san pietro 6874 ; SZ 6874
• Manufacturer Contact: marco giannessi ; strada regina; castel san pietro 6874 ; SZ 6874
• MDR Report Key: 23836916
• Report Number: 3005180920-2025-01225
• Device Sequence Number: 17413415
• Product Code: JDI
• UDI-Device Identifier: 07630030805158
• UDI-Public: 07630030805158
• Combination Product (Y/N): N
• PMA/510(K) Number: K072857
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2025
• Device Explanted Year: 2025
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 12/18/2025

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Model Number: 01.25.021
• Device Lot Number: 2422891
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/26/2025
• Initial Report FDA Received Date: 12/18/2025
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 02/03/2025
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 69 YR
• Patient Sex: Female
• Patient Ethnicity: Non Hispanic
• Patient Race: White