MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA CUP: VERSAFITCUP CC TRIO 01.26.45.0056 ACETABULAR SHELL CC TRIO Ø 56; HIP ACETABULAR SHELL

Catalog Number	01.26.45.0056
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	10/04/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Batch review performed on 09 october 2023 lot 2247196: (b)(4) items manufactured and released on 22-mar-2023.Expiration date: 2028-03-02.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 medical affairs department: a revision surgery was performed 1 month after a primary tha.During a routine x-ray check, the acetabular component (versafit cup trio) appeared shifted.It is reported that the patient did not complain of pain and there were no signs of infection.From the available x ray images, the acetabular cup appears to be displaced maybe due to a post surgery migration.The reason should be probably found in lack of primary stability.With the information at hand, it is difficult to suspect a defective or malfunctioning device.
Event or Problem Description
At one month from the primary, revision surgery due to malpositioned versafitcup cc trio cup.The surgeon had noticed during a routine radiological check that the acetabulum cup had shifted.The patient did not complain of pain and there were no infectious problems.

• Brand Name: CUP: VERSAFITCUP CC TRIO 01.26.45.0056 ACETABULAR SHELL CC TRIO Ø 56
• Common Device Name: HIP ACETABULAR 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: 18063714
• Report Number: 3005180920-2023-00842
• Device Sequence Number: 8076757
• Product Code: LZO
• UDI-Device Identifier: 07630030807794
• UDI-Public: 07630030807794
• 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: 2023
• Device Explanted Year: 2023
• 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): 11/03/2023

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 Catalogue Number: 01.26.45.0056
• Device Lot Number: 2247196
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/04/2023
• Initial Report FDA Received Date: 11/03/2023
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 03/22/2023
• 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: 72 YR
• Patient Sex: Female
• Patient Weight: 68 KG