MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA CUP: MPACT DOUBLE MOBILITY ACETABULAR SHELL Ø60; UNCEMENTED ACETABULAR SHELL

Catalog Number 01.32.160MB

Device Problem Loose or Intermittent Connection (1371)

Patient Problem Failure of Implant (1924)

Event Date 05/31/2019

Event Type  Injury  

Manufacturer Narrative

Batch review performed on 12 jun 2019: lot 185439: (b)(4) items manufactured and released on 22-oct-2018.Expiration date: 2023-10-14.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

During the primary hip surgery and after implanting the dm cup, the surgeon observed that the cup was loose.The surgeon removed the cup, and implanted a slurry bone graft and reimplanted the cup, but the cup was still loose.The surgeon chose to implant a multi hole cup with screws and the surgeon stated it was well fixated.The surgery was completed successfully.

• Brand Name: CUP: MPACT DOUBLE MOBILITY ACETABULAR SHELL Ø60
• Type of Device: UNCEMENTED 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: 8734042
• MDR Text Key: 149179718
• Report Number: 3005180920-2019-00524
• Device Sequence Number: 1
• Product Code: LPH
• UDI-Device Identifier: 07630030861017
• UDI-Public: 07630030861017
• 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: company representative
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 06/26/2019

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: 10/14/2023
• Device Catalogue Number: 01.32.160MB
• Device Lot Number: 185439
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 05/31/2019
• Initial Date FDA Received: 06/26/2019
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 10/22/2018
• 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): Other