MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA CUP: MPACT DOUBLE MOBILITY 5; DOUBLE MOBILITY ACETABULAR SHELL

Model Number	01.32.154MB
Health Effect - Clinical Code	Joint Dislocation (2374)
Date of Event	08/16/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Batch review performed on 6 sept 2021: lot 2009458: (b)(4) items manufactured and released on 16-feb-2021.Expiration date: 2026-feb-03.No anomalies found related to the problem.To date, (b)(4) items of the same lot have been sold without any similar reported event.Another device involved: batch review performed on 6 sept 2021: liner: versafitcup dm 01.26.2854mhc double mobility hc liner ø 54/28 (k092265) lot 2010827: (b)(4) items manufactured and released on 10-nov-2020.Expiration date: 2025-oct-29.No anomalies found related to the problem.To date, (b)(4) items of the same lot have been sold without any similar reported event.
Event or Problem Description
The patient came in reporting pain due to a dislocation of the liner from the cup.The cause of the dislocation is unknown.The same day of the primary surgery, the surgeon revised the cup, head, liner and stem.The surgery was completed successfully.

• Brand Name: CUP: MPACT DOUBLE MOBILITY 5
• Common Device Name: DOUBLE MOBILITY ACETABULAR SHELL
• Manufacturer (Section D): MEDACTA INTERNATIONAL SA; strada regina; castel san pietro, 6874 ; SZ 6874
• MDR Report Key: 12467146
• Report Number: 3005180920-2021-00728
• Device Sequence Number: 4738778
• Product Code: LPH
• UDI-Device Identifier: 07630030860980
• UDI-Public: 07630030860980
• 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: 2021
• Device Explanted Year: 2021
• 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): 09/14/2021

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: 02/03/2026
• Device Model Number: 01.32.154MB
• Device Catalogue Number: 01.32.154MB
• Device Lot Number: 2009458
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/16/2021
• Initial Report FDA Received Date: 09/14/2021
• 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