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

Model Number	01.25.012
Health Effect - Clinical Code	Unspecified Infection (1930)
Date of Event	01/08/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Batch review performed on 20 january 2021: lot 100917: 50 items manufactured and released on 11-june-2010.Expiration date: 2015-04-30.No anomalies found related to the problem.To date, 48 items of the same lot have been already sold.No other similar events have been reported since 2017.Additional device involved batch review performed on 20 january 2021: liner: cc e cc light 01.26.2839hct flat pe hc liner ø 28 / c (k103352) lot 100724: 25 items manufactured and released on 06-april-2010.Expiration date: 2015-02-28.No anomalies found related to the problem.To date, 25 items of the same lot have been already sold.No other similar events have been reported since 2017.
Event or Problem Description
Revision surgery due to infection 10 years 7 months after the primary and the pathogen is unknown.The surgeon revised the head and liner and the surgery was completed successfully.

• Brand Name: COCR BALL HEAD 12/14 28 SIZE M 0
• Common Device Name: HIP METALLIC BALL HEAD
• Manufacturer (Section D): MEDACTA INTERNATIONAL SA; strada regina; castel san pietro, 6874 ; SZ 6874
• MDR Report Key: 11271432
• Report Number: 3005180920-2021-00086
• Device Sequence Number: 4372194
• Product Code: JDI
• UDI-Device Identifier: 07630030805110
• UDI-Public: 07630030805110
• Combination Product (Y/N): N
• Initial Reporter Country: SZ
• PMA/510(K) Number: K072857
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2010
• 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): 02/03/2021

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: 04/30/2015
• Device Model Number: 01.25.012
• Device Catalogue Number: 01.25.012
• Device Lot Number: 100917
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/08/2021
• Initial Report FDA Received Date: 02/03/2021
• 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