MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA CUP: MPACT DOUBLE MOBILITY ACETABULAR SHELL Ø56

Catalog Number 01.32.156MB

Device Problem Positioning Problem (3009)

Patient Problem Joint Disorder (2373)

Event Date 10/01/2019

Event Type  Injury  

Manufacturer Narrative

Batch review performed on 07 october 2019.Lot 1900195: 51 items manufactured and released on 18-jun-2019.Expiration date: 2024-06-09.No anomalies found related to the problem.To date, 29 items of the same lot have been already sold without any other similar reported event.Clinical evaluation performed by medical affairs director.Dislocation due to implant mobilization occurred in day 1 after cementless total hip arthroplasty.The cup was incompletely seated in the bone due to insufficient acetabular preparation.The reason of this choice is unknown: one reason may be patient particular anatomy or bone morphology that cannot be assessed as no preoperative image is available.There is no reason to suspect a faulty device.

Event Description

The patient came in complaining of pain, and the cause of the pain was a dislocation.Post-op x-rays indicated that the cup was placed too lateral which caused a dislocation.The surgeon revised the cup 1 day after primary surgery.The surgery was completed successfully.

• Brand Name: CUP: MPACT DOUBLE MOBILITY ACETABULAR SHELL Ø56
• Type of Device: DOUBLE MOBILITY ACETABULAR SHELL
• 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: 9260078
• MDR Text Key: 164865581
• Report Number: 3005180920-2019-00912
• Device Sequence Number: 1
• Product Code: LPH
• UDI-Device Identifier: 07630030860997
• UDI-Public: 07630030860997
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K143453
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: other
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 10/31/2019

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
• Device Operator: Health Professional
• Device Catalogue Number: 01.32.156MB
• Device Lot Number: 1900195
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 10/01/2019
• Initial Date FDA Received: 10/31/2019
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 06/18/2019
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention