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

Model Number	01.26.2858MHC
Health Effect - Clinical Code	Unspecified Infection (1930)
Date of Event	09/11/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Batch review performed on 21 september 2020.Lot 1908432: (b)(4) items manufactured and released on 13-dec-2019.Expiration date: 2024-12-01.No anomalies found related to the problem.To date, 21 items of the same lot have been already sold without any similar reported event.Additional device involved: ball heads: mectacer 01.29.203 biolox delta ceramic ball head 12/14 ø 28 size l +3.5 (k112115) lot.1908980.Batch review performed on 21 september 2020.Lot 1908980: (b)(4) items manufactured and released on 10-feb-2020.Expiration date: 2025-01-21.No anomalies found related to the problem.To date, 42 items of the same lot have been already sold without any similar reported event.
Event or Problem Description
The patient came in, 2 months after primary surgery, 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.

• Brand Name: LINER: VERSAFITCUP DM DOUBLE MOBILITY HC LINER 28/DMI
• Common Device Name: ACETABULAR LINER DOUBLE MOBILITY
• Manufacturer (Section D): MEDACTA INTERNATIONAL SA; strada regina; castel san pietro, 6874 ; SZ 6874
• MDR Report Key: 10647876
• Report Number: 3005180920-2020-00697
• Device Sequence Number: 14464041
• Product Code: MEH
• UDI-Device Identifier: 07630030807442
• UDI-Public: 07630030807442
• Combination Product (Y/N): N
• 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): N
• Reporter Type: Manufacturer
• Report Source: other
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 10/08/2020

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: 12/01/2024
• Device Model Number: 01.26.2858MHC
• Device Catalogue Number: 01.26.2858MHC
• Device Lot Number: 1908432
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/11/2020
• Initial Report FDA Received Date: 10/08/2020
• 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