MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA LINER: VERSAFITCUP DM DOUBLE MOBILITY HC LINER Ø 60/28; HIP ACETABULAR LINER DOUBLE MOBILITY

Model Number	01.26.2860MHC
Health Effect - Clinical Code	Unspecified Infection (1930)
Date of Event	01/19/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
The patient came in due to signs of an infection and the pathogen is unknown.At 2 months from the primary surgery the surgeon performed a washout and revised the head and liner.The surgery was completed successfully.
Additional Manufacturer Narrative
Batch review performed on 25 january 2022: lot 2104158: (b)(4) items manufactured and released on 09-jun-2021.Expiration date: 2026-may-24.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 component involved: ball heads: mectacer 01.29.202 biolox delta ceramic ball head 12/14 ø 28 size m 0 (k112115) lot.2103137.Lot 2103137: (b)(4) items manufactured and released on 28-jun-2021.Expiration date: 2026-jun-15.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: LINER: VERSAFITCUP DM DOUBLE MOBILITY HC LINER Ø 60/28
• Common Device Name: HIP ACETABULAR LINER DOUBLE MOBILITY
• 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: 13523956
• Report Number: 3005180920-2022-00114
• Device Sequence Number: 20158367
• Product Code: MEH
• UDI-Device Identifier: 07630030807473
• UDI-Public: 07630030807473
• Combination Product (Y/N): N
• Initial Reporter State: IL
• Initial Reporter Country: US
• PMA/510(K) Number: K092265
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2021
• 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): 02/14/2022

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: 05/24/2026
• Device Model Number: 01.26.2860MHC
• Device Catalogue Number: 01.26.2860MHC
• Device Lot Number: 2104158
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/19/2022
• Initial Report FDA Received Date: 02/14/2022
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 06/09/2021
• 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: Unknown