MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA COCR FEMORAL BALL HEAD; COCR BALL HEAD 12/14 Ø28 MM SIZE XL

Model Number	01.25.014
Medical Device Problem Code	Device Appears to Trigger Rejection (1524)
Health Effect - Clinical Code	Medical device site infection (4845)
Date of Event	06/29/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
Revision surgery due to infection after 26 days from primary.The surgeon performed a washout and revised the 12/14 d 28 mm size xl cocr head to a same size head, and revised the double mobility hc liner d 28/dme to a same size liner.
Additional Manufacturer Narrative
Batch review performed on 07 july 2026 cocr 01.25.014 cocr ball head 12/14 d 28 mm size xl (k072857) lot.2216820: (b)(4) items manufactured and released on 23-sep-2022.Expiration date: 2027-sep-02.No anomalies found related to the problem.To date, (b)(4) items of the same lot have been sold with no similar reported events during the period of review.Mpact dm 01.26.2850mhc double mobility hc liner d 28/dme (k092265) lot.2525821: (b)(4) items manufactured and released on 04-dec-2025.Expiration date: 2030-nov-17.No anomalies found related to the problem.To date, (b)(4) items of the same lot have been sold with no similar reported events during the period of review.Root cause: infection is a known possible complication of any surgery.Although no root cause can be established, there is no indication that any issue with the device may have caused or contributed to the event, and the document review does not indicate any potential manufacturing related cause.

• Brand Name: COCR FEMORAL BALL HEAD
• Common Device Name: COCR BALL HEAD 12/14 Ø28 MM SIZE XL
• 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: 25778112
• Report Number: 3005180920-2026-00693
• Device Sequence Number: 10686874
• Product Code: JDI
• UDI-Device Identifier: 07630030805134
• UDI-Public: 07630030805134
• Combination Product (Y/N): N
• PMA/510(K) Number: K072857
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2026
• Device Explanted Year: 2026
• 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): 07/10/2026

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: 01.25.014
• Device Lot Number: 2216820
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/29/2026
• Initial Report FDA Received Date: 07/10/2026
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 09/23/2022
• 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: 84 YR
• Patient Sex: Female
• Patient Weight: 91 KG
• Patient Race: White