MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA MPACT FLAT PE HC LINER Ø32/E; HIP SHELL LINER

Model Number	01.32.3244HCT
Health Effect - Clinical Code	Unspecified Infection (1930)
Date of Event	02/23/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
At about 1 month after the primary, 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 02 march 2022: lot 2109536: (b)(4) items manufactured and released on 14-sep-2021.Expiration date: 2026-08-29.No anomalies found related to the problem.To date, (b)(4) items of the same lot have been sold without any similar reported event.Additional device involved: batch review performed on 02 march 2022: ball heads: mectacer 01.29.205 biolox delta ceramic ball head 12/14 ø 32 size m 0 (k112115) lot 2107480: (b)(4) items manufactured and released on 29-sep-2021.Expiration date: 2026-09-09.No anomalies found related to the problem.To date, (b)(4) items of the same lot have been sold without any similar reported event.

• Brand Name: MPACT FLAT PE HC LINER Ø32/E
• Common Device Name: HIP SHELL 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: 13802611
• Report Number: 3005180920-2022-00196
• Device Sequence Number: 20099586
• Product Code: LPH
• UDI-Device Identifier: 07630030811913
• UDI-Public: 07630030811913
• 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: 2022
• Device Explanted Year: 2022
• 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): 03/17/2022

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: 08/29/2026
• Device Model Number: 01.32.3244HCT
• Device Catalogue Number: 01.32.3244HCT
• Device Lot Number: 2109536
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/23/2022
• Initial Report FDA Received Date: 03/17/2022
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 09/14/2021
• 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: Male