MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA CUP: MPACT DOUBLE MOBILITY ACETABULAR SHELL Ø50; HIP CEMENTLESS SHELL

Catalog Number	01.32.150MB
Health Effect - Clinical Code	Joint Disorder (2373)
Date of Event	11/04/2017
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Batch review performed on 15 november 2019: lot 171762: 55 items manufactured and released on 4-aug-2017.Expiration date: 2022-07-25.No anomalies found related to the problem.To date, 53 the items of the same lot have been already sold without any similar reported event.Clinical evaluation performed by medacta medical affairs director: 2 years after primary dm cementless tha, the hip turns painful and partial revision is carried out, reportedly due to psoas impingement with a protruding cup (or perhaps mobile liner).No responsibility for this adverse event should be ascribed to implant malfunction or defect.
Event or Problem Description
Revision surgery performed 2 years and 1 month after the primary due to pain caused by a cup impingement with iliopsoas tendon.The cause of the cup impingement is unknown.The surgeon revised the head, cup, liner and stem and the surgery was completed successfully.No metalosis was present.

• Brand Name: CUP: MPACT DOUBLE MOBILITY ACETABULAR SHELL Ø50
• Common Device Name: HIP CEMENTLESS SHELL
• Manufacturer (Section D): MEDACTA INTERNATIONAL SA; strada regina; castel san pietro, 6874 ; SZ 6874
• MDR Report Key: 9410176
• Report Number: 3005180920-2019-01005
• Device Sequence Number: 11221243
• Product Code: LPH
• UDI-Device Identifier: 07630030860966
• UDI-Public: 07630030860966
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K143453
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2017
• Device Explanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: other
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 12/04/2019

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
• Operator of Device: Health Professional
• Device Expiration Date: 07/25/2022
• Device Catalogue Number: 01.32.150MB
• Device Lot Number: 171762
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/04/2019
• Initial Report FDA Received Date: 12/04/2019
• 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