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

Catalog Number 01.26.48MB

Device Problem Malposition of Device (2616)

Patient Problem No Code Available (3191)

Event Date 11/30/2019

Event Type  Injury  

Manufacturer Narrative

Batch review performed on 4 december 2019. Lot 165684: (b)(4) items manufactured and released on 25-jan-2017 expiration date: 01/10/2022. 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 events. Additional implant involved: stem: minimax 01. 13. 102r cementless anatomical stem right size 2 (k170845) lot. 172015. Batch review performed on 4 december 2019 lot 172015: (b)(4) items manufactured and released on 31-aug-2017 expiration date: 18/08/2022. 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 events. Clinical evaluation performed by medical affairs manager hip revision surgery performed 1 year and 8 months after cementless double mobility total hip arthroplasty in a (b)(6) year old woman. Radiographic image provided shows suboptimal cup position. The reason of this choice is unknown: bone morphology or patient anatomy may be one reason but this cannot be confirmed on the basis of a single anteroposterior x-ray. There is no reason to suspect a faulty device.

Event Description

Revision surgery performed 1 year and 9 months after the primary due to impingement (the cup with the stem or the lesser trochanter with the pelvis). The cup was anteverted (the cause is unknown). The surgeon revised the head and liner. Infection not present.

• Brand Name: CUP: VERSAFITCUP ACETABULAR SHELL Ø 48
• Type of Device: ACETABULAR CUP
• 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: 9525226
• MDR Text Key: 188116305
• Report Number: 3005180920-2019-01084
• Device Sequence Number: 1
• Product Code: MEH
• Combination Product (y/n): N
• Reporter Country Code: AS
• 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: 12/27/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/27/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No

Device Operator

• Device Expiration Date: 01/10/2022
• Device Catalogue Number: 01.26.48MB
• Device Lot Number: 165684
• Was Device Available for Evaluation?: No

Is the Reporter a Health Professional?

Was the Report Sent to FDA?

• Event Location: No Information
• Date Manufacturer Received: 11/30/2019
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 01/25/2017
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial

Patient Treatment Data

Date Received: 12/27/2019 Patient Sequence Number: 1