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

Catalog Number	01.25.011
Health Effect - Clinical Code	Joint Dislocation (2374)
Date of Event	03/22/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Batch review performed on 13 april 2018: lot 175379: 60 items manufactured and released on 30 november 2017.Expiration date: 2022-11-14.No anomalies found related to the issue.To date, 36 items of the same lot have been already sold without any similar reported event.Clinical evaluation performed by medical affairs director on (b)(6) 2018 immediate postoperative hip dislocation after cemented hemiarthroplasty in an elderly lady ((b)(6)) probably occurred during patient mobilization.The short head was exchanged, and although there is no information available as to the new head, we can presume that a longer head has been chosen, in order to enhance soft tissue tension.This adverse event is most probably not related to a malfunctioning device.
Event or Problem Description
During post-op x-rays the hip was found to be dislocated; the patient was revised on the same day using a new head.The surgery was completed successfully.The surgeon replaced the size s ball head with an xl size one.No other component was revised.

• Brand Name: COCR BALL HEAD 12/14 Ø 28 SIZE S -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: 7446810
• Report Number: 3005180920-2018-00255
• Device Sequence Number: 1768475
• Product Code: JDI
• UDI-Device Identifier: 07630030805103
• UDI-Public: 07630030805103
• Combination Product (Y/N): N
• Initial Reporter Country: US
• 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: Other
• Type of Report: Initial
• Report Date (Section B): 04/20/2018

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: 11/14/2022
• Device Catalogue Number: 01.25.011
• Device Lot Number: 175379
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/22/2018
• Initial Report FDA Received Date: 04/20/2018
• 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
• Patient Age: 81 YR