MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA CUP: VERSAFITCUP ACETABULAR SHELL CC Ø 50

Catalog Number 01.26.50MB

Device Problem Material Protrusion/Extrusion (2979)

Patient Problem Hip Fracture (2349)

Event Date 04/15/2019

Event Type  Injury  

Manufacturer Narrative

Batch review performed on 13 may 2019 lot 187024: (b)(4) items manufactured and released on 28-jan-2019.Expiration date: 2024-01-15.No anomalies found related to the problem.To date, (b)(4) items of the same lot have been already sold without any similar reported event.Clinical evaluation performed by medical affairs manager: immediate postoperative acetabular cup protrusion through the medial wall after total hip arthroplasty.No information concerning patient age, health status and bone quality is available.This event may be caused by the normal intraoperative bone weakening during acetabular preparation that may have led to the formation of subclinical fissures.There is no reason to suspect a malfunctioning device.

Event Description

The patient had a primary hip surgery on (b)(6) 2019.Upon reviewing the post-op x-rays, it was discovered that the cup had protruded through the medial wall during impaction.The surgeon revised, 6 days later, the cup and liner with another company's product and implanted bone chips to promote bone growth in the acetabulum.The surgery was completed successfully.

• Brand Name: CUP: VERSAFITCUP ACETABULAR SHELL CC Ø 50
• Type of Device: ACETABULAR SHELL
• Manufacturer (Section D): MEDACTA INTERNATIONAL SA; strada regina; castel san pietro, 6874 ; SZ 6874
• Manufacturer (Section G): MEDACTA INTERNATIONAL SA; strada regina; castel san pietro, 6874 ; SZ 6874
• Manufacturer Contact: stefano baj ; strada regina; castel san pietro, switzerland 6874 ; SZ 6874
• MDR Report Key: 8607929
• MDR Text Key: 144973384
• Report Number: 3005180920-2019-00370
• 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: 05/14/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/14/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 01/15/2024
• Device Catalogue Number: 01.26.50MB
• Device Lot Number: 187024
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 04/15/2019
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 01/28/2019
• 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