MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA LINER: VERSAFITCUP DM DOUBLE MOBILITY HC LINER 52/28

Model Number	01.26.2852MHC
Health Effect - Clinical Code	Unspecified Infection (1930)
Date of Event	09/15/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Batch review performed by medacta regulatory affairs department on 25 september 2020: lot 1908429: (b)(4) items manufactured and released on 10-jan-2020.Expiration date: 2024-12-11.No anomalies found related to the problem.To date, 40 items of the same lot have been already sold without any other similar reported event.Other device involved in the event: ball heads: mectacer 01.29.201 biolox delta ceramic ball head 12/14 ø 28 size s -3.5 lot.1909748 (k112115).Batch review performed by medacta regulatory affairs department on 25 september 2020: lot 1909748: (b)(4) items manufactured and released on 16-mar-2020.Expiration date: 2025-02-26.No anomalies found related to the problem.To date, 116 items of the same lot have been already sold without any other similar reported event.
Event or Problem Description
The patient came in due to signs of infection 1 month after the primary surgery and the pathogen is unknown.The surgeon performed a washout and revised the head and liner.The surgery was completed successfully.

• Brand Name: LINER: VERSAFITCUP DM DOUBLE MOBILITY HC LINER 52/28
• Common Device Name: DOUBLE MOBILITY HC LINER
• Manufacturer (Section D): MEDACTA INTERNATIONAL SA; strada regina; castel san pietro, 6874 ; SZ 6874
• MDR Report Key: 10668667
• Report Number: 3005180920-2020-00703
• Device Sequence Number: 10871936
• Product Code: MEH
• UDI-Device Identifier: 07630030807343
• UDI-Public: 07630030807343
• Combination Product (Y/N): Y
• 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: 2020
• Device Explanted Year: 2020
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 10/13/2020

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: 12/11/2024
• Device Model Number: 01.26.2852MHC
• Device Catalogue Number: 01.26.2852MHC
• Device Lot Number: 1908429
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/15/2020
• Initial Report FDA Received Date: 10/13/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention