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

Catalog Number	01.25.123
Health Effect - Clinical Code	Unspecified Infection (1930)
Date of Event	10/23/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Batch review performed on 20 november 2018: lot 180830: (b)(4) items manufactured and released on 22-may-2018.Expiration date: 2023-05-08.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.Additional component revised: ball heads: bipolar head 25060.2242 bipolar head ø22x42, lot 145513: (b)(4) items manufactured and released on 29-oct-2014.Expiration date: 2019-09-30.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
The patient came in due to signs of infection 1 month after the primary.The pathogen is unknown at this time.The surgeon performed a washout and head exchange.

• Brand Name: COCR BALL HEAD 12/14 Ø 22 SIZE M 0
• Common Device Name: COCR FEMORAL HEAD
• Manufacturer (Section D): MEDACTA INTERNATIONAL SA; strada regina; castel san pietro, switzerland 6874 ; SZ 6874
• MDR Report Key: 8089814
• Report Number: 3005180920-2018-00933
• Device Sequence Number: 11137521
• Product Code: JDI
• UDI-Device Identifier: 07630030805479
• UDI-Public: 07630030805479
• 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: 2018
• Device Explanted Year: 2018
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 11/20/2018

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: 05/08/2023
• Device Catalogue Number: 01.25.123
• Device Lot Number: 180830
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/23/2018
• Initial Report FDA Received Date: 11/20/2018
• 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