MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA MPACT DOUBLE MOBILITY ACETABULAR SHELL 46; HIP UNCEMENTED SHELL

Model Number	01.32.146MB
Health Effect - Clinical Code	Joint Dislocation (2374)
Date of Event	12/23/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Batch review performed on 20 january 2021: lot 157200: (b)(4) items manufactured and released on 24-feb-2016.Expiration date: 2021-02-14.No anomalies found related to the problem.To date, 25 items of the same lot have been already sold.No other similar events have been reported since 2017.Additional device involved: batch review performed on 20 january 2021: liner: mpact dm 01.26.2246mhc double mobility hc liner 22.2/dmc (k092265) lot 2003317: (b)(4) items manufactured and released on 06-july-2020.Expiration date: 2025-06-24.No anomalies found related to the problem.To date, 25 items of the same lot have been already sold without any other similar reported event.
Event or Problem Description
The patient came in reporting pain due to a dislocation of the head from the acetabulum (liner from cup) and the cause of the dislocation is unknown.The cup was well fixed in the acetabulum and the dislocation was between the liner and the shell.The surgeon revised the cup, liner, and head 2 months after the primary and the surgery was completed successfully.

• Brand Name: MPACT DOUBLE MOBILITY ACETABULAR SHELL 46
• Common Device Name: HIP UNCEMENTED SHELL
• Manufacturer (Section D): MEDACTA INTERNATIONAL SA; strada regina; castel san pietro, 6874 ; SZ 6874
• MDR Report Key: 11200972
• Report Number: 3005180920-2021-00063
• Device Sequence Number: 2270333
• Product Code: LPH
• UDI-Device Identifier: 07630030860942
• UDI-Public: 07630030860942
• 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: 2020
• Device Explanted Year: 2020
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: other
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 01/20/2021

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: 02/14/2021
• Device Model Number: 01.32.146MB
• Device Catalogue Number: 01.32.146MB
• Device Lot Number: 157200
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/23/2020
• Initial Report FDA Received Date: 01/20/2021
• 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