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
Medical Device Problem Code	Malposition of Device (2616)
Health Effect - Clinical Code	Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available (4581)
Date of Event	12/07/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
Revision surgery due to overhang versafitcup cc trio cup.Cup, head and liner successfully revised.Primary info not available.
Additional 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.
Additional 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
• Common Device Name: 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
• Report Number: 3005180920-2023-01063
• Device Sequence Number: 7617679
• Product Code: LZO
• UDI-Device Identifier: 07630030807787
• UDI-Public: 07630030807787
• Combination Product (Y/N): N
• Initial Reporter Country: SZ
• PMA/510(K) Number: K103352
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Explanted Year: 2023
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 01/30/2024

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: 12/10/2025
• Device Catalogue Number: 01.26.45.0054
• Device Lot Number: 2009363
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/07/2023
• Supplement Date Received by Manufacturer: 12/07/2023
• Initial Report FDA Received Date: 12/22/2023
• Supplement Report FDA Received Date: 01/30/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 12/21/2020
• 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 Age: 67 YR
• Patient Sex: Female
• Patient Weight: 68 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White