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

Catalog Number	01.25.012
Health Effect - Clinical Code	No Code Available (3191)
Date of Event	10/12/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Batch review performed on 09 november 2018.Lot 180322: (b)(4) items manufactured and released on 22 may 2018.Expiration date: 2023-05-10 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.Other device involved: liner cc e cc light flat pe hc liner ø 28 / c reference 01.26.2839hct (lzo).Lot 177500: (b)(4) items manufactured and released on 13 march 2018.Expiration date: 2023-02-27 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.Clinical evaluation performed by medical affairs director on november 09, 2018.Revision occurred 1 month after total hip arthroplasty due to luxation in a (b)(6) woman.This event may be due to a traumatic event but no information that can confirm this hypothesis was reported.The cause of this failure cannot be determined, but there is no reason to suspect a faulty implant.
Event or Problem Description
Revision surgery performed, 1 month after primary surgery, due to hip luxation.Luxation from the head to the liner.

• Brand Name: COCR BALL HEAD 12/14 Ø 28 SIZE M 0
• Common Device Name: COCR BALL HEAD
• Manufacturer (Section D): MEDACTA INTERNATIONAL SA; strada regina; castel san pietro, switzerland 6874 ; SZ 6874
• MDR Report Key: 8054894
• Report Number: 3005180920-2018-00881
• Device Sequence Number: 1225628
• 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: 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): 11/09/2018

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 Catalogue Number: 01.25.012
• Device Lot Number: 180322
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/12/2018
• Initial Report FDA Received Date: 11/09/2018
• 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
• Patient Age: 71 YR
• Patient Weight: 72