MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA COCR BALL HEAD 12/14 Ø 32 SIZE S -3.5

Catalog Number	01.25.021
Health Effect - Clinical Code	Pain (1994)
Date of Event	10/19/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Batch review performed on 13 november 2018: lot 147308: (b)(4) items manufactured and released on 11 march 2015.Expiration date: 2020-01-31.No anomalies found related to the issue.To date, (b)(4) items of the same lot have been already sold without any similar reported event.Other device involved: mpact flat pe hc liner ø32/e reference 01.32.3244hct.Lot 133196: (b)(4) items manufactured and released on 07 october 2013.Expiration date: 2018-08-31.No anomalies found related to the issue.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 16, 2018, 3.5 years after primary cementless tha dislocation of the joint occurred.This is likely due to intervened laxity of soft tissues.No report of a secondary damage of the components has been received, hence we should suppose that the event was not caused by any device malfunction.The most common causes for dislocation are insufficient soft tissue tension, inadequate geometry restoration, component malposition.
Event or Problem Description
The patient came in complaining of pain 3 years and half after the primary.The head dislocated from the liner on the patient's right hip.The surgeon revised the cup, liner and head.

• Brand Name: COCR BALL HEAD 12/14 Ø 32 SIZE S -3.5
• Common Device Name: COCR BALL HEAD
• Manufacturer (Section D): MEDACTA INTERNATIONAL SA; strada regina; castel san pietro, switzerland 6874 ; SZ 6874
• MDR Report Key: 8077518
• Report Number: 3005180920-2018-00912
• Device Sequence Number: 1887770
• Product Code: JDI
• UDI-Device Identifier: 07630030805158
• UDI-Public: 07630030805158
• 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: 2015
• 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): 11/16/2018

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: 01/31/2020
• Device Catalogue Number: 01.25.021
• Device Lot Number: 147308
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/19/2018
• Initial Report FDA Received Date: 11/16/2018
• 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