MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA COCR BALL HEAD 12/14 36 SIZE XXL +10.5; HIP COCR BALL HEAD

Model Number	01.25.034
Health Effect - Clinical Code	Unspecified Infection (1930)
Date of Event	03/06/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Batch review performed on 29.03.2021: lot 185568: (b)(4) items manufactured and released on 19-sep-2018.Expiration date: 2023-09-05.No anomalies found related to the problem.To date, (b)(4) items of the same lot have been already sold without any other similar reported event.Additional device involved batch review performed on 29:march.2021: liner: mpact 01.32.3648hct flat pe hc liner ø36/f (k103721) lot 2006539: (b)(4) items manufactured and released on 9-sep-2020.Expiration date: 2025-08-30.No anomalies found related to the problem.To date, (b)(4) items of the same lot have been already sold without any other similar reported event.
Event or Problem Description
On (b)(6) 2021, the patient came in due to signs of an infection and the pathogen is unknown.The surgeon performed a washout and revised the head and liner (implanted 3 weeks before in a previous revision surgery).The surgery was completed successfully.

• Brand Name: COCR BALL HEAD 12/14 36 SIZE XXL +10.5
• Common Device Name: HIP COCR BALL HEAD
• Manufacturer (Section D): MEDACTA INTERNATIONAL SA; strada regina; castel san pietro, 6874 ; SZ 6874
• MDR Report Key: 11581252
• Report Number: 3005180920-2021-00260
• Device Sequence Number: 11801604
• Product Code: JDI
• UDI-Device Identifier: 07630030805240
• UDI-Public: 07630030805240
• Combination Product (Y/N): N
• Initial Reporter State: IL
• Initial Reporter Country: US
• PMA/510(K) Number: K080885
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2021
• Device Explanted Year: 2021
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 03/29/2021

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: 09/05/2023
• Device Model Number: 01.25.034
• Device Catalogue Number: 01.25.034
• Device Lot Number: 185568
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/06/2021
• Initial Report FDA Received Date: 03/29/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 57 YR