MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA LINER: MPACT FLAT PE HC LINER Ø32/E

Catalog Number	01.32.3244HCT
Health Effect - Clinical Code	Unspecified Infection (1930)
Date of Event	09/03/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Batch review performed on 09 september 2019 lot 181814: (b)(4) items manufactured and released on 13-jun-2018.Expiration date: 2023-05-29.No anomalies found related to the problem.To date, (b)(4) items of the same lot have been already sold without any other similar reported event.Additional implant involved in the event, batch review performed on 09 september 2019: ball heads: cocr 01.25.022 cocr ball head 12/14 ø 32 size m 0 (k072857) lot.181735 lot 181735: (b)(4) items manufactured and released on 21-jun-2018.Expiration date: 2023-06-12.No anomalies found related to the problem.To date, (b)(4) items of the same lot have been already sold without any other similar reported event.
Event or Problem Description
The patient came in due to signs of an infection and the pathogen is unknown.The surgeon revised the liner and the head 9 months and 1 week after primary.The surgery was completed successfully.

• Brand Name: LINER: MPACT FLAT PE HC LINER Ø32/E
• Common Device Name: FLAT PE HC LINER
• Manufacturer (Section D): MEDACTA INTERNATIONAL SA; strada regina; castel san pietro, 6874 ; SZ 6874
• MDR Report Key: 9145160
• Report Number: 3005180920-2019-00832
• Device Sequence Number: 2810919
• Product Code: LPH
• UDI-Device Identifier: 07630030811913
• UDI-Public: 07630030811913
• Combination Product (Y/N): N
• Initial Reporter State: IL
• Initial Reporter Country: US
• PMA/510(K) Number: K103721
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2018
• 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): 10/02/2019

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: 05/29/2023
• Device Catalogue Number: 01.32.3244HCT
• Device Lot Number: 181814
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/03/2019
• Initial Report FDA Received Date: 10/02/2019
• 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