MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA LINER: MPACT FACE-CHANGING 10° PE HC LINER Ø40/G; ACETABULR PE HC LINER

Model Number	01.32.4052HC10A
Health Effect - Clinical Code	Unspecified Infection (1930)
Date of Event	03/15/2022
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Batch review performed on 21 march 2022: lot 1810856: (b)(4).Expiration date: 2024-03-19.No anomalies found related to the problem.(b)(4).Additional implant involved: stem: amistem c 01.18.151 cemented std stem size 1 (k103189) lot.1903200 batch review performed on 21 march 2022: lot 1903200: (b)(4).Expiration date: 2024-08-21.No anomalies found related to the problem.(b)(4).Additional implant involved: ball heads: mectacer 01.29.212 biolox delta ceramic ball head 12/14 ø 40 size s - 4 (k112115) lot.1908999 batch review performed on 21 march 2022: lot 1908999: (b)(4).Expiration date: 2025-01-25.No anomalies found related to the problem.(b)(4).
Event or Problem Description
The patient came in due to signs of an infection and the pathogen is unknown.At 3 months from the primary the surgeon removed all components (the cup was from a competitor), performed a washout, and reimplanted permanent hardware.The surgery was completed successfully.
Additional Manufacturer Narrative
On (b)(6) 2022, 2nd stage revision has been performed,.Spacer removed and final devices implanted successfully.

• Brand Name: LINER: MPACT FACE-CHANGING 10° PE HC LINER Ø40/G
• Common Device Name: ACETABULR 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: 14109994
• Report Number: 3005180920-2022-00253
• Device Sequence Number: 5543099
• Product Code: LPH
• UDI-Device Identifier: 07630040731270
• UDI-Public: 07630040731270
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K183582
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2021
• Device Explanted Year: 2022
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Other
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 07/08/2022

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: 03/19/2024
• Device Model Number: 01.32.4052HC10A
• Device Catalogue Number: 01.32.4052HC10A
• Device Lot Number: 1810856
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/15/2022
• Supplement Date Received by Manufacturer: 06/23/2022
• Initial Report FDA Received Date: 04/14/2022
• Supplement Report FDA Received Date: 07/08/2022
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 04/04/2019
• 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: Unknown