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

Device Problem Malposition of Device (2616)

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

Event Date 10/04/2023

Event Type  Injury  

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 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
• Type of Device: 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
• MDR Text Key: 327239915
• Report Number: 3005180920-2023-00842
• Device Sequence Number: 1
• Product Code: LZO
• UDI-Device Identifier: 07630030807794
• UDI-Public: 07630030807794
• 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
• Report Date: 11/03/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/03/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: 01.26.45.0056
• Device Lot Number: 2247196
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 10/04/2023
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 03/22/2023
• 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: 72 YR
• Patient Sex: Female
• Patient Weight: 68 KG