MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA MPACT DOUBLE MOBILITY ACETABULAR SHELL 56; HIP UNCEMENTED SHELL

Model Number	01.32.156MB
Health Effect - Clinical Code	Joint Disorder (2373)
Date of Event	07/28/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Batch review performed by medacta regulatory affairs department on (b)(6) 2020: lot 184747: (b)(4) items manufactured and released on 2-oct-2018.Expiration date: 2023-sep-25.No anomalies found related to the problem.To date, (b)(4) items of the same lot have been already sold with one other similar reported event.
Event or Problem Description
The patient came in after 1 year and 5 months from the primary for a post-op appointment and the surgeon observed that the acetabular shell was not well fixed within the acetabulum.The surgeon decided to revise the patient and revised the shell, liner, and femoral ceramic head.The surgery was completed successfully.

• Brand Name: MPACT DOUBLE MOBILITY ACETABULAR SHELL 56
• Common Device Name: HIP UNCEMENTED SHELL
• Manufacturer (Section D): MEDACTA INTERNATIONAL SA; strada regina; castel san pietro, 6874 ; SZ 6874
• MDR Report Key: 10458657
• Report Number: 3005180920-2020-00557
• Device Sequence Number: 11312442
• Product Code: LPH
• UDI-Device Identifier: 07630030860997
• UDI-Public: 07630030860997
• 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: 2019
• Device Explanted Year: 2020
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 08/27/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 09/25/2023
• Device Model Number: 01.32.156MB
• Device Catalogue Number: 01.32.156MB
• Device Lot Number: 184747
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/28/2020
• Initial Report FDA Received Date: 08/27/2020
• 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