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

Device Problem Appropriate Term/Code Not Available (3191)

Patient Problem Joint Dislocation (2374)

Event Date 11/10/2020

Event Type  Injury  

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 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
• Type of Device: DUAL MOBILITY HC LINER
• Manufacturer (Section D): MEDACTA INTERNATIONAL SA; strada regina; castel san pietro, 6874 ; SZ 6874
• Manufacturer (Section G): MEDACTA INTERNATIONAL SA; strada regina; castel san pietro, 6874 ; SZ 6874
• Manufacturer Contact: stefano baj ; strada regina; castel san pietro, switzerland 6874 ; SZ 6874
• MDR Report Key: 10959367
• MDR Text Key: 219972413
• Report Number: 3005180920-2020-00878
• Device Sequence Number: 1
• Product Code: MEH
• UDI-Device Identifier: 07630030806834
• UDI-Public: 07630030806834
• Combination Product (y/n): Y
• Reporter Country Code: US
• PMA/PMN Number: K092265
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 12/07/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/07/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: No
• Device Operator: 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
• Date Manufacturer Received: 11/10/2020
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 07/26/2018
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention