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

Catalog Number	01.26.50MB
Health Effect - Clinical Code	Hip Fracture (2349)
Date of Event	04/15/2019
Type of Reportable Event	Serious Injury
Additional 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 or Problem 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
• Common Device Name: ACETABULAR SHELL
• Manufacturer (Section D): MEDACTA INTERNATIONAL SA; strada regina; castel san pietro, 6874 ; SZ 6874
• MDR Report Key: 8607929
• Report Number: 3005180920-2019-00370
• Device Sequence Number: 14001552
• Product Code: MEH
• UDI-Device Identifier: 07630030808067
• UDI-Public: 07630030808067
• Combination Product (Y/N): N
• Initial Reporter State: IL
• Initial Reporter Country: US
• PMA/510(K) Number: K083116
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• Device Explanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 05/14/2019

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: 01/15/2024
• Device Catalogue Number: 01.26.50MB
• Device Lot Number: 187024
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/15/2019
• Initial Report FDA Received Date: 05/14/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention