MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA BALL HEADS: COCR BALL HEAD 12/14 Ø 32 SIZE S -3.5; HIP COCR BALL HEAD

Model Number	01.25.021
Health Effect - Clinical Code	Pain (1994)
Date of Event	03/10/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
The patient came in reporting pain and the cause of the pain is laxity.At 1 year and 1 month after the primary surgery, the surgeon found the stem to be well fixed, so he decided to only revise the head.The surgery was completed successfully.
Additional Manufacturer Narrative
Batch review performed on 17 march 2022.Lot 2004968: (b)(4) items manufactured and released on 15-sep-2020.Expiration date: 2025-sep-03.No anomalies found related to the problem.To date, (b)(4) items of the same lot have been sold with no similar reported event.

• Brand Name: BALL HEADS: COCR BALL HEAD 12/14 Ø 32 SIZE S -3.5
• Common Device Name: HIP COCR BALL HEAD
• Manufacturer (Section D): MEDACTA INTERNATIONAL SA; strada regina; castel san pietro, 6874 ; CH 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: 13995306
• Report Number: 3005180920-2022-00241
• Device Sequence Number: 4432996
• Product Code: JDI
• UDI-Device Identifier: 07630030805158
• UDI-Public: 07630030805158
• Combination Product (Y/N): N
• Initial Reporter State: IL
• Initial Reporter Country: US
• PMA/510(K) Number: K072857
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2021
• Device Explanted Year: 2022
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Other
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 04/04/2022

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: 09/03/2025
• Device Model Number: 01.25.021
• Device Catalogue Number: 01.25.021
• Device Lot Number: 2004968
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/10/2022
• Initial Report FDA Received Date: 04/04/2022
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 09/15/2020
• 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: Female