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

Model Number	01.26.45.0054
Medical Device Problem Codes	Device Appears to Trigger Rejection (1524); Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Medical device site infection (4845)
Date of Event	10/04/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
Revision surgery for suspected infection.The surgeon removed all implants, (the stem and head were from competitor).The surgeon implanted competitor devices.Patient history: primary surgery on (b)(6) 2020.First revision on (b)(6) 2024 for stem loosening (stem and head of competitor implanted).Second revsion on (b)(6) 2024 for suspected infection and loosening of competitor stem.
Additional Manufacturer Narrative
Batch review performed on 09 october 2024.Lot 2006326: (b)(4) items manufactured and released on 24-sep-2020.Expiration date: 2025-09-15.No anomalies found related to the problem.To date, (b)(4) items of the same lot have been sold with no similar reported event during the period of review.Clinical evaluation performed by clinical study department: a second revision surgery was performed one month after a first revision surgery on a total hip arthroplasty (tha) due to a suspected infection.No details on the patient's clinical status were provided.During the procedure, the femoral stem (from a competitor company) was found to be mobilized, while the medacta acetabular cup remained stable.Nevertheless, all components were explanted and replaced with a competitor's prosthesis.The available x-ray images are of very poor quality, making it difficult to draw conclusions regarding the condition of the medacta acetabular cup.If the infection is confirmed, it could be considered the likely cause for the revision of the acetabular component, despite its stability.Infections are a well-documented complication, thoroughly described in the literature.At this time, there is no indication to suggest that the failure was linked to the medacta implanted devices themselves.Additional implants involved: mectacer 01.29.413 ceramic liner ø 36 / e lot 2006665: (b)(4) items manufactured and released on 30-sep-2020.Expiration date: 2025-09-21.No anomalies found related to the problem.To date, (b)(4) items of the same lot have been sold with no similar reported event during the period of review.Not registered in usa.Root-cause description: infection is a known possible complication of any surgery.Although no root cause can be established, there is no indication that any issue with the device may have caused or contributed to the event, and the document review does not indicate any potential manufacturing related cause.

• Brand Name: VERSAFITCUP CC TRIO ACETABULAR SYSTEM
• Common Device Name: VERSAFITCUP CC TRIO ACETABULAR SHELL CC TRIO Ø 54
• 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: 20578477
• Report Number: 3005180920-2024-00889
• Device Sequence Number: 8095455
• Product Code: MEH
• 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 Implanted Year: 2020
• Device Explanted Year: 2024
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 10/31/2024

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: 09/15/2024
• Device Model Number: 01.26.45.0054
• Device Lot Number: 2006326
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/04/2024
• Initial Report FDA Received Date: 10/31/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 09/24/2020
• 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: 77 YR
• Patient Sex: Male
• Patient Weight: 96 KG