MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA CUP: VERSAFITCUP CC TRIO ACETABULAR SHELL CC TRIO Ø 48

Model Number	01.26.45.0046
Health Effect - Clinical Code	Joint Disorder (2373)
Date of Event	01/22/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Batch review performed on 28.01.2020.Lot 167547: (b)(4) items manufactured and released on 20.03.2017.Expiration date: 2022-03-08.No anomalies found related to the problem.To date, (b)(4) items of the same lot have been already sold without any other similar reported event since 2016.Clinical evaluation: revision surgery performed 8 months after cementless total hip arthroplasty due to femoral stem impingement with the acetabular rim.In the radiographic image provided acetabular component seems anteverted and the reason of this implant position is unknown.However, no conclusion can be drawn on the basis of a single anteroposterior postoperative projection.In this case, there is no reason to suspect a malfunctioning device.Preliminary investigation: preliminary investigation performed on 13th february 2020.The cup slightly shows a sign on the rim; basing on the received information, there are no reasons to suspect a malfunctioning of the device.From the received images it is not possible to determine the root cause of the event, it is possible that an high anteverted positioning of the cup could have caused the impingement between cup and stem.Other device involved in the event stem: quadra-h 01.12.21sn cementless, ha coated std stem # 1, short neck lot.187840 (k082792).Batch review performed on 28.01.2020.Lot 187840: (b)(4) items manufactured and released on 12.12.2018.Expiration date: 2023-12-03.No anomalies found related to the problem.To date, (b)(4) items of the same lot have been already sold without any other similar reported event since 2016.
Event or Problem Description
Revision surgery performed 9 months after the primary due to the impingement between the cup and the stem.The cause of the impingement is unknown.The cup, liner and ball head were revised.

• Brand Name: CUP: VERSAFITCUP CC TRIO ACETABULAR SHELL CC TRIO Ø 48
• Common Device Name: ACETABULAR SHELL
• Manufacturer (Section D): MEDACTA INTERNATIONAL SA; strada regina; castel san pietro, 6874 ; SZ 6874
• MDR Report Key: 9710885
• Report Number: 3005180920-2020-00058
• Device Sequence Number: 3650374
• Product Code: LZO
• UDI-Device Identifier: 07630030807749
• UDI-Public: 07630030807749
• Combination Product (Y/N): N
• Initial Reporter Country: SZ
• PMA/510(K) Number: K103352
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• Device Explanted Year: 2020
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 02/14/2020

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: 03/08/2022
• Device Model Number: 01.26.45.0046
• Device Catalogue Number: 01.26.45.0046
• Device Lot Number: 167547
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/16/2020
• Initial Report FDA Received Date: 02/14/2020
• 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
• Patient Weight: 52