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

Model Number	01.32.160MB
Health Effect - Clinical Code	Unspecified Infection (1930)
Date of Event	02/14/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Batch review performed on 26 february 2020: lot 176967: (b)(4) items manufactured and released on 11-jan-2018.Expiration date: 2023-01-01.No anomalies found related to the problem.To date, (b)(4) items of the same lot have been already sold with another similar reported event.Other devices involved in the event: ball heads: mectacer 01.29.208 biolox delta ceramic ball head 12/14 ø 36 size s - 4 lot.1901941.Batch review performed on 26 february 2020: lot 1901941: (b)(4) items manufactured and released on 03-jun-2019.Expiration date: 2024-05-18.No anomalies found related to the problem.To date, (b)(4) items of the same lot have been already sold with another similar reported event.
Event or Problem Description
The patient came in due to signs of infection 18 days after the primary and the pathogen is unknown.The surgeon revised the head and liner and 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: 9826672
• Report Number: 3005180920-2020-00150
• Device Sequence Number: 2422020
• Product Code: LPH
• UDI-Device Identifier: 07630030861017
• UDI-Public: 07630030861017
• 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: 2020
• Device Explanted Year: 2020
• Reporter Type: Manufacturer
• Report Source: other
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 03/12/2020

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: No Information
• Device Expiration Date: 01/01/2023
• Device Model Number: 01.32.160MB
• Device Catalogue Number: 01.32.3652HCT
• Device Lot Number: 176967
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/14/2020
• Initial Report FDA Received Date: 03/12/2020
• 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