MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA BALL HEADS: COCR BALL HEAD 12/14 Ø 28 SIZE M 0; HIP COCR BALL HEAD

Catalog Number	01.25.012
Health Effect - Clinical Code	Unspecified Infection (1930)
Date of Event	04/19/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Batch review performed on 14 may 2019: lot 183774: (b)(4) items manufactured and released on 09-oct-2018.Expiration date: 2023-09-27.No anomalies found related to the problem.To date, (b)(4) items of the same lot have been already sold without any similar reported event one other device was involved in the event ball heads: bipolar head 25060.2852 bipolar head ø28x52 lot.180856 (k091967): (b)(4) items manufactured and released on 18-jun-2018.Expiration date: 2023-06-03.No anomalies found related to the problem.To date, (b)(4) items of the same lot have been already sold without any similar reported event.
Event or Problem Description
Revision surgery performed after 2 months and 18 days form the primary due to signs of infection and the pathogen is unknown.The surgeon performed a washout and revised the cocr head and the bipolar head.The surgery was completed successfully.

• Brand Name: BALL HEADS: COCR BALL HEAD 12/14 Ø 28 SIZE M 0
• Common Device Name: HIP COCR BALL HEAD
• Manufacturer (Section D): MEDACTA INTERNATIONAL SA; strada regina; castel san pietro, 6874 ; SZ 6874
• MDR Report Key: 8619675
• Report Number: 3005180920-2019-00392
• Device Sequence Number: 13996476
• Product Code: JDI
• UDI-Device Identifier: 07630030805110
• UDI-Public: 07630030805110
• 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: 2019
• Device Explanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 05/17/2019

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: 09/27/2023
• Device Catalogue Number: 01.25.012
• Device Lot Number: 183774
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/19/2019
• Initial Report FDA Received Date: 05/17/2019
• 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