MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA LINER: MPACT DM DOUBLE MOBILITY HC LINER 22.2/DMC; DUAL MOBILITY HC LINER

Model Number	01.26.2246MHC
Health Effect - Clinical Code	Joint Dislocation (2374)
Date of Event	11/10/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Batch review performed on 20 november 2020: lot 184721: (b)(4) items manufactured and released on 26-july-2018.Expiration date: 2023-07-15.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 clinical evalaution: hip dislocation 3 months after implantation of a double mobility implant in a challenging case due to patient clinical history of a surgically treated intertrochanteric fracture.Dislocation probably occurred during rehabilitation.Hip dislocation may be due to component positioning or insufficient soft tissue tensioning; it can hardly be caused by standard devices.Other device involved in the event: liner: mpact 01.32.3844mc dm converter liner e/dmc lot.1903442 (k131458).Batch review performed on 20 november 2020: lot 1903442: (b)(4) items manufactured and released on 06-nov-2019.Expiration date: 2024-10-23.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 or Problem Description
Revision surgery for dislocation of the dm poly liner from the dm converter (dm poly liner and cocr head remained coupled).The surgeon revised successfully the liners and cocr head.

• Brand Name: LINER: MPACT DM DOUBLE MOBILITY HC LINER 22.2/DMC
• Common Device Name: DUAL MOBILITY HC LINER
• Manufacturer (Section D): MEDACTA INTERNATIONAL SA; strada regina; castel san pietro, 6874 ; SZ 6874
• MDR Report Key: 10959367
• Report Number: 3005180920-2020-00878
• Device Sequence Number: 11367635
• Product Code: MEH
• UDI-Device Identifier: 07630030806834
• UDI-Public: 07630030806834
• Combination Product (Y/N): Y
• Initial Reporter State: IL
• Initial Reporter Country: US
• PMA/510(K) Number: K092265
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2020
• Device Explanted Year: 2020
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 12/07/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Expiration Date: 07/15/2023
• Device Model Number: 01.26.2246MHC
• Device Catalogue Number: 01.26.2246MHC
• Device Lot Number: 184721
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/10/2020
• Initial Report FDA Received Date: 12/07/2020
• 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