MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA VERSAFITCUP CC TRIO ACETABULAR SHELL CC TRIO Ø 54; HIP CEMENTLESS SHELL

Catalog Number 01.26.45.0054

Device Problem Malposition of Device (2616)

Patient Problem Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)

Event Date 12/07/2023

Event Type  Injury  

Event Description

Revision surgery due to overhang versafitcup cc trio cup.Cup, head and liner successfully revised.Primary info not available.

Manufacturer Narrative

Batch review performed on 20 december 2023: lot 2009363: (b)(4) items manufactured and released on 21-dec-2020.Expiration date: 2025-12-10.No anomalies found related to the problem.To date, all items of the same lot have been sold without any similar reported event during the period of review.Investigation performed by r&d knee manager: from the received images, it is not possible to determine the root cause of the event; the cup seems to be without any particular defect or damage, while the ceramic ball head was without any particular sign, except for the several scratches most probably related to the revision/removal.A possible reason can be related to the size of the implant, as the second chosen size revealed to be well fixed.

Manufacturer Narrative

Clinical evaluation performed on the (b)(6) 2024 by medacta clinical affairs manager: acetabular cup revised due to iliopsoas irritation.Most probably, this may have been caused by anterior overhang of the cup.From the radiographic images, the cup appears in suboptimal position.There is no reason to suspect a malfunctioning device.

• Brand Name: VERSAFITCUP CC TRIO ACETABULAR SHELL CC TRIO Ø 54
• Type of Device: HIP CEMENTLESS SHELL
• 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: 18382170
• MDR Text Key: 331181068
• Report Number: 3005180920-2023-01063
• Device Sequence Number: 1
• Product Code: LZO
• UDI-Device Identifier: 07630030807787
• UDI-Public: 07630030807787
• Combination Product (y/n): N
• Reporter Country Code: SZ
• PMA/PMN Number: K103352
• 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,Followup
• Report Date: 01/30/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/22/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: 01.26.45.0054
• Device Lot Number: 2009363
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 12/07/2023
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 12/21/2020
• 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 Age: 67 YR
• Patient Sex: Female
• Patient Weight: 68 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White