MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA COCR BALL HEAD 12/14 Ø 28 SIZE L +3.5

Catalog Number	01.25.013
Health Effect - Clinical Code	Unspecified Infection (1930)
Date of Event	07/25/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Batch review performed on 31-july-2019.Lot 166592: 150 items manufactured and released on 07-mar-2017.Expiration date: 2022-02-21.No anomalies found related to the problem.To date, (b)(4) items of the same lot have been already sold with 2 other similar reported event.Another device involved.Batch review for ball heads: bipolar head 25060.2851 bipolar head ø28x51 lot.164204 (k091967): 7 items manufactured and released on 12-oct-2016.Expiration date: 2021-09-25.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
The patient came in due to signs of an infection and the pathogen is unknown.The surgeon performed an i&d and revised the 28mm cocr head l with a 28mm cocr head l and revised the bipolar head 51mm/28 with a bipolar head 51mm/28 1 month after primary.The surgery was completed successfully.

• Brand Name: COCR BALL HEAD 12/14 Ø 28 SIZE L +3.5
• Common Device Name: COCR BALL HEAD
• Manufacturer (Section D): MEDACTA INTERNATIONAL SA; strada regina; castel san pietro, 6874 ; SZ 6874
• MDR Report Key: 8919936
• Report Number: 3005180920-2019-00705
• Device Sequence Number: 13960249
• Product Code: JDI
• UDI-Device Identifier: 07630030805127
• UDI-Public: 07630030805127
• 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): 08/22/2019

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: 02/21/2022
• Device Catalogue Number: 01.25.013
• Device Lot Number: 166592
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/25/2019
• Initial Report FDA Received Date: 08/22/2019
• 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