MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA LINER: MPACT FLAT PE HC LINER Ø40/F; HIP LINER PE

Model Number	01.32.4048HCT
Health Effect - Clinical Code	Unspecified Infection (1930)
Date of Event	05/30/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
At about 3 months after the primary surgery, 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.
Additional Manufacturer Narrative
Batch review performed on (b)(6) 2022.Lot 2102165: 40 items manufactured and released on 08-apr-2021.Expiration date: 2026-mar-23.No anomalies found related to the problem.To date, 26 items of the same lot have been sold with no similar reported case during the period of review.Other component revised: ball heads: mectacer 01.29.215 biolox delta ceramic ball head 12/14 ø 40 size xl +8 (k112115) lot.2107509: 60 items manufactured and released on 21-sep-2021.Expiration date: 2026-sep-07.No anomalies found related to the problem.To date, 30 items of the same lot have been sold with no similar reported case during the period of review.

• Brand Name: LINER: MPACT FLAT PE HC LINER Ø40/F
• Common Device Name: HIP LINER PE
• 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: 14839490
• Report Number: 3005180920-2022-00489
• Device Sequence Number: 4833195
• Product Code: LZO
• UDI-Device Identifier: 07630030812262
• UDI-Public: 07630030812262
• Combination Product (Y/N): N
• Initial Reporter State: IL
• Initial Reporter Country: US
• PMA/510(K) Number: K122641
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2022
• Device Explanted Year: 2022
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 06/28/2022

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: 03/23/2026
• Device Model Number: 01.32.4048HCT
• Device Catalogue Number: 01.32.4048HCT
• Device Lot Number: 2102165
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/30/2022
• Initial Report FDA Received Date: 06/28/2022
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 04/08/2021
• 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