MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA VERSAFITCUP DM DOUBLE MOBILITY HC LINER Ø 52/28; HIP DOUBLE MOBILITY LINER

Catalog Number	01.26.2852MHC
Medical Device Problem Code	Appropriate Device Problem Term/Code Not Available (3191)
Health Effect - Clinical Code	Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available (4581)
Date of Event	07/25/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
The patient had a primary competitor hip surgery on an unknown date.On (b)(6) 2021, the patient came in for unknown reasons and had a partial revision to a medacta stem, head and liner that was matched to the internal diameter of the existing acetabular implant from the initial resurfacing surgery.On (b)(6) 2023, the patient came in due to the development of a pseudo tumor that formed in the pelvis, behind the acetabular implant.The surgeon revised the competitor cup and medacta stem, head and liner to all new medacta components.The surgery was completed successfully.Note: it has been reported that there were no issues with medacta implants, the surgeon needed to remove everything to gain exposure to the tumor.
Additional Manufacturer Narrative
Batch review performed on 31-jul-2023: lot 2003321: (b)(4) items manufactured and released on 20-jul-2020.Expiration date: 2025-07-07.No anomalies found related to the problem.To date, all items of the same lot have been sold with no similar reported case during the period of the review.Additional devices involved: batch reviews performed on 31-jul-2023: lot 2009388: (b)(4) items manufactured and released on 26-jan-2021.Expiration date: 2026-01-11.No anomalies found related to the problem.To date, (b)(4) items of the same lot have been sold with no similar reported case during the period of the review.Stem: masterloc 01.39.007 cementless ti coated std stem size 7 ((b)(6)) lot 171329: (b)(4) items manufactured and released on 06-oct-2017.Expiration date: 2022-09-25.No anomalies found related to the problem.To date, all items of the same lot have been sold with no similar reported case during the period of the review.

• Brand Name: VERSAFITCUP DM DOUBLE MOBILITY HC LINER Ø 52/28
• Common Device Name: HIP DOUBLE MOBILITY 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: 17486504
• Report Number: 3005180920-2023-00641
• Device Sequence Number: 7881345
• Product Code: MEH
• UDI-Device Identifier: 07630030807343
• UDI-Public: 07630030807343
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K092265
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2021
• Device Explanted Year: 2023
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 08/09/2023

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
• Operator of Device: Health Professional
• Device Expiration Date: 07/07/2025
• Device Catalogue Number: 01.26.2852MHC
• Device Lot Number: 2003321
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/25/2023
• Initial Report FDA Received Date: 08/09/2023
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 07/20/2020
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Male