MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA VERSAFITCUP DM DOUBLE MOBILITY HC LINER Ø 62/28; HIP LINER

Catalog Number 01.26.2862MHC

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Event Date 09/19/2023

Event Type  Injury  

Event Description

The patient had a primary knee surgery on (b)(6) 2019.On (b)(6) 2020, the patient came in due to signs of an infection and the pathogen is unknown.The surgeon performed a washout and revised the head and liner.The surgery was completed successfully.On (b)(6) 2020, the patient came in due to signs of an infection and the pathogen is unknown.The surgeon performed a washout and revised the cup, head, liner, and stem.The surgery was completed successfully.Presently, on (b)(6) 2023, the patient came in due to signs of an infection and the pathogen is unknown.The surgeon performed a washout and revised the head and liner.The surgery was completed successfully.

Manufacturer Narrative

Batch review performed on 26 september 2023.Lot 1904374: (b)(4) items manufactured and released on 24-jul-2019.Expiration date: 2024-jul-08.No anomalies found related to the problem.To date, 10 items of the same lot have been sold with no similar reported event during the period of review.Additional implant involved, batch review performed on 26 september 2023: mectacer 01.29.202 biolox delta ceramic ball head 12/14 ø 28 size m 0 (k112115) lot 1906462: (b)(4) items manufactured and released on 31-oct-2019.Expiration date: 2024-oct-13.No anomalies found related to the problem.To date, (b)(4) items of the same lot have been sold with 7 similar reported events during the period of review.

• Brand Name: VERSAFITCUP DM DOUBLE MOBILITY HC LINER Ø 62/28
• Type of Device: HIP LINER
• Manufacturer (Section D): MEDACTA INTERNATIONAL SA; strada regina; castel san pietro, switzerland 6874 ; SZ 6874
• Manufacturer (Section G): MEDACTA INTERNATIONAL SA; strada regina; castel san pietro, switzerland 6874 ; SZ 6874
• Manufacturer Contact: marco giannessi ; strada regina; castel san pietro, switzerland 6874 ; SZ 6874
• MDR Report Key: 17904838
• MDR Text Key: 325288355
• Report Number: 3005180920-2023-00799
• Device Sequence Number: 1
• Product Code: MEH
• UDI-Device Identifier: 07630030807503
• UDI-Public: 07630030807503
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K092265
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Company Representative
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 10/10/2023

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
• Device Operator: Health Professional
• Device Catalogue Number: 01.26.2862MHC
• Device Lot Number: 1904374
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 09/19/2023
• Initial Date FDA Received: 10/10/2023
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 07/24/2019
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Sex: Male