MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA BALL HEADS: MECTACER HEAD BIOLOX OPTION Ø 28; HIP IMPLANT, CERAMIC BALL HEAD

Model Number	01.29.230H
Health Effect - Clinical Code	Joint Dislocation (2374)
Date of Event	01/07/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Batch review performed on 13 january 2020.Lot 19c0002: (b)(4) items manufactured and released on 31-jan-2019.Expiration date: 2024-01-16.No anomalies found related to the problem.To date, (b)(4) items of the same lot have been already sold without any other similar reported event.Clinical evaluation performed by medical affairs manager: hip dislocation 6 months after primary implantation.Hip dislocation may be due to component positioning or insufficient soft tissue tensioning; it can hardly be caused by standard devices.Other device involved in the event, batch review performed on 13 january 2020.Liner: cc e cc light 01.26.2837 hct flat pe hc liner ø 28 / b (k122911) lot.185869 lot 185869: (b)(4) items manufactured and released on 25-sep-2018.Expiration date: 2023-08-30.No anomalies found related to the problem.To date, (b)(4) items of the same lot have been already sold without any other similar reported event since 2016.
Event or Problem Description
The patient came in reporting pain due to a dislocation.The cause of the dislocation is unknown.The surgeon initially planned to revise the cup, but after opening the patient decided to only revise the sleeve and head due to the patient having poor bone quality and age.The surgery was completed successfully almost 5 months after primary.

• Brand Name: BALL HEADS: MECTACER HEAD BIOLOX OPTION Ø 28
• Common Device Name: HIP IMPLANT, CERAMIC BALL HEAD
• Manufacturer (Section D): MEDACTA INTERNATIONAL SA; strada regina; castel san pietro, 6874 ; SZ 6874
• MDR Report Key: 9675276
• Report Number: 3005180920-2020-00026
• Device Sequence Number: 19428865
• Product Code: LZO
• UDI-Device Identifier: 07630030809323
• UDI-Public: 07630030809323
• Combination Product (Y/N): N
• Initial Reporter State: IL
• Initial Reporter Country: US
• PMA/510(K) Number: K131518
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• Device Explanted Year: 2020
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 02/06/2020

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: 01/16/2024
• Device Model Number: 01.29.230H
• Device Catalogue Number: 01.29.230H
• Device Lot Number: 19C0002
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/07/2020
• Initial Report FDA Received Date: 02/06/2020
• 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