MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA MPACT 01.32.3648HCT FLAT PE HC LINER Ø36/F

Model Number	01.32.3648HCT
Health Effect - Clinical Code	Unspecified Infection (1930)
Date of Event	11/30/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Batch review performed on 07.12.2021.Lot 2107103: (b)(4).Expiration date: 2026-06-14.No anomalies found related to the problem.(b)(4).Other devices involved: batch review performed on 07.12.2021 mectacer 01.29.210 biolox delta ceramic ball head 12/14 ø 36 size l + 4 (k112115) lot 2100273: (b)(4).Expiration date: 2026-04-12.No anomalies found related to the problem.(b)(4).
Event or Problem Description
At one week after the previous revision, the patient came in due to signs of an infection and the pathogen is unknown.The surgeon performed a washout and revised the head and liner.The surgery was completed successfully.This is the second revision surgery performed due to infection.

• Brand Name: MPACT 01.32.3648HCT FLAT PE HC LINER Ø36/F
• Common Device Name: FLAT PE HC LINER
• Manufacturer (Section D): MEDACTA INTERNATIONAL SA; strada regina; castel san pietro, 6874 ; SZ 6874
• Manufacturer (Section G): MEDACTA INTERNATIONAL SA; strada regina; castel san pietro, 6874 ; SZ 6874
• Manufacturer Contact: stefano baj ; strada regina; castel san pietro, switzerland 6874 ; SZ 6874
• MDR Report Key: 13078024
• Report Number: 3005180920-2021-01008
• Device Sequence Number: 5630069
• Product Code: LPH
• UDI-Device Identifier: 07630030812132
• UDI-Public: 07630030812132
• 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: 2021
• Device Explanted Year: 2021
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 12/23/2021

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: 06/14/2026
• Device Model Number: 01.32.3648HCT
• Device Catalogue Number: 01.32.3648HCT
• Device Lot Number: 2107103
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/30/2021
• Initial Report FDA Received Date: 12/23/2021
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 07/01/2021
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Female