MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA BALL HEADS: COCR COCR BALL HEAD 12/14 Ø 22 SIZE M 0; METALLIC BALL HEAD

Model Number	01.25.123
Health Effect - Clinical Code	Unspecified Infection (1930)
Date of Event	03/19/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
At about 1 month after the primary, the patient came in due to signs of an infection and the pathogen is unknown.The surgeon performed a washout and revised the cocr head and bipolar head.The surgery was completed successfully.
Additional Manufacturer Narrative
Batch review performed on 20 april 2022.Lot 2010474: (b)(4) items manufactured and released on 26-jan-2021.Expiration date: 2026-01-13.No anomalies found related to the problem.To date, (b)(4) items of the same lot have been sold without any similar reported event.Additional implant involved: ball heads: bipolar head 25060.2241 bipolar head ø22x41 (k091967) lot.1905687.Batch review performed on 20 april 2022.Lot 1905687: (b)(4) items manufactured and released on 23-oct-2019.Expiration date: 2024-10-12.No anomalies found related to the problem.To date, (b)(4) items of the same lot have been sold without any similar reported event.

• Brand Name: BALL HEADS: COCR COCR BALL HEAD 12/14 Ø 22 SIZE M 0
• Common Device Name: METALLIC BALL HEAD
• Manufacturer (Section D): MEDACTA INTERNATIONAL SA; strada regina; castel san pietro, 6874 ; SZ 6874
• Manufacturer (Section G): MEDACTA INTERNATIONAL SA; strada regina; castel san pietro, 6874 ; SZ 6874
• Manufacturer Contact: stefano baj ; strada regina; castel san pietro, switzerland 6874 ; SZ 6874
• MDR Report Key: 14165804
• Report Number: 3005180920-2022-00274
• Device Sequence Number: 5025020
• Product Code: JDI
• UDI-Device Identifier: 07630030805479
• UDI-Public: 07630030805479
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K080885
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2022
• Device Explanted Year: 2022
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 04/21/2022

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 Expiration Date: 01/13/2026
• Device Model Number: 01.25.123
• Device Catalogue Number: 01.25.123
• Device Lot Number: 2010474
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/22/2022
• Initial Report FDA Received Date: 04/21/2022
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 01/26/2021
• 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 Sex: Unknown