MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA LINER: MPACT DOUBLE MOBILITY HC LINER Ø 54/28

Catalog Number	01.26.2854MHC
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 1903332: (b)(4) items manufactured and released on 24-jul-2019.Expiration date: 2024-07-08.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.Additional implant involved in the event, batch review performed on 20 december 2019.Ball heads: mectacer 01.29.202 biolox delta ceramic ball head 12/14 ø 28 size m 0 (k112115) lot.1903847 lot 1903847: (b)(4) items manufactured and released on 26-jul-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 with one similar event reported.
Event or Problem Description
The patient came in, one month after primary surgery, due to signs of infection and the pathogen is unknown.The surgeon performed a washout and revised the head and liner.The surgery was completed successfully.

• Brand Name: LINER: MPACT DOUBLE MOBILITY HC LINER Ø 54/28
• Common Device Name: DOUBLE MOBILITY HC LINER
• Manufacturer (Section D): MEDACTA INTERNATIONAL SA; strada regina; castel san pietro, 6874 ; SZ 6874
• MDR Report Key: 9580570
• Report Number: 3005180920-2019-01141
• Device Sequence Number: 3244058
• Product Code: MEH
• UDI-Device Identifier: 07630030807381
• UDI-Public: 07630030807381
• Combination Product (Y/N): N
• 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: 2019
• Device Explanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: company representative
• 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: 07/08/2024
• Device Catalogue Number: 01.26.2854MHC
• Device Lot Number: 1903332
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/17/2019
• 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