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

Catalog Number 01.32.156MB

Device Problem Device Slipped (1584)

Patient Problem Inadequate Osseointegration (2646)

Event Date 05/16/2019

Event Type  Injury  

Manufacturer Narrative

Batch review performed on 07 jun 2019: lot 184747: (b)(4) items manufactured and released on 02-oct-2018.Expiration date: 2023-09-25.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 Description

Revision surgery performed after 1,5 month due to pain caused by a loose cup.The surgeon revised the 56mm mpact dm cup with a 58mm mpact two hole cup and also revised the head and liner.Te patient was diabetic.The surgery was completed successfully.

• Brand Name: CUP: MPACT DOUBLE MOBILITY ACETABULAR SHELL Ø56
• Type of Device: UNCEMENTED HIP 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: 8699599
• MDR Text Key: 148017258
• Report Number: 3005180920-2019-00468
• 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: 06/14/2019

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 Expiration Date: 09/25/2023
• Device Catalogue Number: 01.32.156MB
• Device Lot Number: 184747
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 05/17/2019
• Initial Date FDA Received: 06/14/2019
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 02/10/2018
• 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