MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA CUP: VERSAFITCUP ACETABULAR SHELL CC Ø 54; CEMENTLESS ACETABULAR SHELL

Catalog Number	01.26.54MB
Health Effect - Clinical Code	Joint Disorder (2373)
Date of Event	02/28/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Batch review performed on 29 march 2019: lot 173545: (b)(4) items manufactured and released on 22-nov-2017.Expiration date: 2022-11-14.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.
Event or Problem Description
Independent sales agent did not have the implants available for the case which caused a delay in the or.The surgeon decided to intraoperatively reposition the acetabular cup after he had implanted all the components.To work on the cup, the surgeon had to explant the liner and femoral head.The agent did not have a second inventory bank and had to get the replacement liner and head from another hospital.We think this caused a 20 - 30 minute delay in the case.

• Brand Name: CUP: VERSAFITCUP ACETABULAR SHELL CC Ø 54
• Common Device Name: CEMENTLESS ACETABULAR SHELL
• Manufacturer (Section D): MEDACTA INTERNATIONAL SA; strada regina; castel san pietro, switzerland 6874 ; SZ 6874
• MDR Report Key: 8464672
• Report Number: 3005180920-2019-00208
• Device Sequence Number: 16479017
• Product Code: MEH
• UDI-Device Identifier: 07630030808128
• UDI-Public: 07630030808128
• 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: 2018
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 03/29/2019

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: 11/14/2022
• Device Catalogue Number: 01.26.54MB
• Device Lot Number: 173545
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/28/2019
• Initial Report FDA Received Date: 03/29/2019
• 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