MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA LINER: MPACT DM DOUBLE MOBILITY HC LINER 28/DMH

Catalog Number	01.26.2856MHC
Health Effect - Clinical Code	Unspecified Infection (1930)
Date of Event	12/17/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Batch review performed on 20 december 2019: lot 1904372: (b)(4) items manufactured and released on 24-july-2019.Expiration date: 2024-07-13.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.Other device involved in the event: ball heads: mectacer 01.29.203 biolox delta ceramic ball head 12/14 ø 28 size l +3.5 lot.189637 (k112115).Batch review performed on 19 december 2019: lot 189637: (b)(4) items manufactured and released on 19-feb-2019.Expiration date: 2024-02-05.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
About 1 month after primary revision surgery for infection.Head and liner revised successfully.

• Brand Name: LINER: MPACT DM DOUBLE MOBILITY HC LINER 28/DMH
• Common Device Name: DOUBLE MOBILITY HC LINER
• Manufacturer (Section D): MEDACTA INTERNATIONAL SA; strada regina; castel san pietro, 6874 ; SZ 6874
• MDR Report Key: 9580030
• Report Number: 3005180920-2019-01144
• Device Sequence Number: 16914013
• Product Code: MEH
• UDI-Device Identifier: 07630030807411
• UDI-Public: 07630030807411
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K092265
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• Device Explanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: other
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 01/13/2020

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: 07/13/2024
• Device Catalogue Number: 01.26.2856MHC
• Device Lot Number: 1904372
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/18/2019
• Initial Report FDA Received Date: 01/13/2020
• 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