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

Catalog Number	01.32.3652HCT
Health Effect - Clinical Code	Unspecified Infection (1930)
Date of Event	08/27/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Batch review performed on 30 august 2019.Lot 1810222: 40 items manufactured and released on 10-dec-2018.Expiration date: 2023-11-28.No anomalies found related to the problem.To date, 17 items of the same lot have been already sold without any other similar reported event.Additional implants involved in the event, batch review performed on 30 august 2019.Ball heads: mectacer 01.29.209 biolox delta ceramic ball head 12/14 ø 36 size m 0 (k112115) lot.1811841.Lot 1811841: 327 items manufactured and released on 07-apr-2019.Expiration date: 2024-03-16.No anomalies found related to the problem.To date, 240 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 head and liner almost 1 month after primary.The surgery was completed successfully.

• Brand Name: LINER: MPACT FLAT PE HC LINER Ø36/G
• Common Device Name: FLAT PE HC LINER
• Manufacturer (Section D): MEDACTA INTERNATIONAL SA; strada regina; castel san pietro, 6874 ; SZ 6874
• MDR Report Key: 9114995
• Report Number: 3005180920-2019-00799
• Device Sequence Number: 11470763
• Product Code: LPH
• UDI-Device Identifier: 07630030812156
• UDI-Public: 07630030812156
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K103721
• 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): 09/25/2019

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: 11/28/2023
• Device Catalogue Number: 01.32.3652HCT
• Device Lot Number: 1810222
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/27/2019
• Initial Report FDA Received Date: 09/25/2019
• 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