MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA LINER: VERSAFITCUP DM DOUBLE MOBILITY HC LINER Ø 58/28; HIP LINER DOUBLE MOBILITY

Catalog Number 01.26.2858MHC

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

Event Date 09/11/2023

Event Type  Injury  

Manufacturer Narrative

Batch review performed on 22 september 2023.Lot 2242684: (b)(4) items manufactured and released on (b)(6) 2022.Expiration date: 2027-11-06.No anomalies found related to the problem.To date, (b)(4) items of the same lot have been sold without any similar reported event during the period of review.

Event Description

At about 1 month and half after the primary, the patient came in due to signs of an infection and the pathogen is unknown.The surgeon performed a washout and revised the liner.The surgery was completed successfully.

• Brand Name: LINER: VERSAFITCUP DM DOUBLE MOBILITY HC LINER Ø 58/28
• Type of Device: HIP LINER DOUBLE MOBILITY
• 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: 17842212
• MDR Text Key: 324556986
• Report Number: 3005180920-2023-00792
• Device Sequence Number: 1
• Product Code: MEH
• UDI-Device Identifier: 07630030807442
• UDI-Public: 07630030807442
• 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: 09/29/2023

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: 01.26.2858MHC
• Device Lot Number: 2242684
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 09/11/2023
• Initial Date FDA Received: 09/29/2023
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 11/17/2022
• 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