MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA CUP: VERSAFITCUP ACETABULAR SHELL Ø 62

Catalog Number	01.26.62MB
Health Effect - Clinical Code	Pain (1994)
Date of Event	09/23/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Batch review performed on 23-oct-2019: lot 113446: 2 items manufactured and released on 28 september 2016.Expiration date: 2021-09-12.No anomalies found related to the problem.To date, all items of the same lot have been already sold without any similar reported event.Clinical evaluation performed by medical affairs department.Acetabular component revision performed 5 months after last revision surgery.An intraoperative fluoroscopic image was provided but it is not clear if it refers to the current revision or the previous one as no date is available.Information received concerning this event does not allow a proper clinical evaluation due to insufficient data.Additional device involved: liner: versafitcup dm 01.26.2862mhc double mobility hc liner 62/28 lot.152697 (k092265) batch review performed on 23-oct-2019: lot 152697: 50 items manufactured and released on 03 august 2015.Expiration date: 2020-06-30.No anomalies found related to the problem.To date, 34 items of the same lot have been already sold without any similar reported event.
Event or Problem Description
The patient came in complaining of pain 5 months after previous surgery, the cause of the pain was a torn tendon.The surgeon performed an abductor tendon repair and revised the cup and liner.The surgery was completed successfully.The patient had a first revision surgery in (b)(6) 2018 performed due to hip dislocation and a second revision in (b)(6) 2019.

• Brand Name: CUP: VERSAFITCUP ACETABULAR SHELL Ø 62
• Common Device Name: ACETABULAR SHELL
• Manufacturer (Section D): MEDACTA INTERNATIONAL SA; strada regina; castel san pietro, 6874 ; SZ 6874
• MDR Report Key: 9224548
• Report Number: 3005180920-2019-00886
• Device Sequence Number: 1891964
• Product Code: MEH
• UDI-Device Identifier: 07630030808265
• UDI-Public: 07630030808265
• 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): 10/23/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 09/12/2021
• Device Catalogue Number: 01.26.62MB
• Device Lot Number: 113446
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/23/2019
• Initial Report FDA Received Date: 10/23/2019
• 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