MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA CUP: VERSAFITCUP 01.26.50MB ACETABULAR SHELL Ø 50; HIP ACETABULAR SHELL

Model Number 01.26.50MB

Device Problem Osseointegration Problem (3003)

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

Event Date 09/29/2022

Event Type  Injury  

Manufacturer Narrative

Batch review performed on 03 october 2022: lot 2110831: (b)(4) items manufactured and released on 22-dec-2021.Expiration date: 2026-12-09.No anomalies found related to the problem.To date, (b)(4) items of the same lot have been sold without any similar reported event in the period of review.

Event Description

Revision surgery at about 2 weeks after primary for cup mobilization.The reason of mobilization is unknown.

• Brand Name: CUP: VERSAFITCUP 01.26.50MB ACETABULAR SHELL Ø 50
• 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: stefano baj ; strada regina; castel san pietro, switzerland 6874 ; SZ 6874
• MDR Report Key: 15690002
• MDR Text Key: 302569190
• Report Number: 3005180920-2022-00790
• Device Sequence Number: 1
• Product Code: MEH
• UDI-Device Identifier: 07630030808067
• UDI-Public: 07630030808067
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K083116
• 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: 10/28/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/28/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 01.26.50MB
• Device Catalogue Number: 01.26.50MB
• Device Lot Number: 2110831
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 09/29/2022
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 12/22/2021
• 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 Sex: Male