MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA MPACT FLAT PE HC LINER Ø36/G; FLAT PE LINER

Catalog Number	01.32.3652HCT
Health Effect - Clinical Code	Unspecified Infection (1930)
Date of Event	11/11/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Batch review performed on 10 december 2018.Lot 168474: (b)(4) items manufactured and released on 28 february 2017.Expiration date: 2022-02-09.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: mectacer biolox delta ceramic ball head 12/14 ø 36 size l + 4 reference 01.29.210; lot 180544: (b)(4) items manufactured and released on 28 may 2018.Expiration date: 15.05.2023-05-15.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.
Event or Problem Description
The surgeon performed a washout and revised the head and liner due to infection 19 days after primary surgery.The pathogen is pseudomonas.

• Brand Name: MPACT FLAT PE HC LINER Ø36/G
• Common Device Name: FLAT PE LINER
• Manufacturer (Section D): MEDACTA INTERNATIONAL SA; strada regina; castel san pietro, switzerland 6874 ; SZ 6874
• MDR Report Key: 8150507
• Report Number: 3005180920-2018-00981
• Device Sequence Number: 13847921
• Product Code: LPH
• UDI-Device Identifier: 07630030812156
• UDI-Public: 07630030812156
• 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: 2018
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 12/11/2018

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: 02/09/2022
• Device Catalogue Number: 01.32.3652HCT
• Device Lot Number: 168474
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/11/2018
• Initial Report FDA Received Date: 12/11/2018
• 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