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

Model Number	01.26.2852MHC
Health Effect - Clinical Code	Unspecified Infection (1930)
Date of Event	08/11/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Batch review performed on 02 september 2020: lot 1910313: (b)(4) items manufactured and released on 18-feb-2020.Expiration date: 2025-02-03.No anomalies found related to the problem.To date, (b)(4) items of the same lot have been already sold with one similar event reported.Additional implant involved: ball heads: mectacer 01.29.203 biolox delta ceramic ball head 12/14 ø 28 size l +3.5 (k112115) lot.1907338.Batch review performed on 02 september 2020: lot 1907338: (b)(4) items manufactured and released on 27-jan-2020.Expiration date: 2025-01-14.No anomalies found related to the problem.To date, (b)(4) items of the same lot have been already sold without any similar reported event.Additional implant involved: cup: mpact 01.32.154mb double mobility acetabular shell ø54 (k143453) lot.1909303.Batch review performed on 02 september 2020: lot 1909303: (b)(4) items manufactured and released on 17-mar-2020.Expiration date: 2025-03-09.No anomalies found related to the problem.To date, (b)(4) items of the same lot have been already sold without any similar reported event.Additional implant involved: stem: amistem c 01.18.103 cemented lat stem size 3 (k103189) lot.188725.Batch review performed on 02 september 2020: lot 188725: (b)(4) items manufactured and released on 17-jan-2019.Expiration date: 2023-12-19.No anomalies found related to the problem.To date, (b)(4) items of the same lot have been already sold without any similar reported event.
Event or Problem Description
The patient had a primary hip surgery on (b)(6) 2020.On (b)(6) 2020, the patient came in due to signs of an infection and the pathogen was unknown.The surgeon performed a washout and revised the head and liner.The surgery was completed successfully.Presently, on (b)(6) 2020, the patient came in due to signs of an infection and the pathogen is unknown.The surgeon performed a washout and revised the head, liner, cup, and stem.The surgery was completed successfully.

• Brand Name: LINER: VERSAFITCUP DM DOUBLE MOBILITY HC LINER 28/DMF
• Common Device Name: ACETABULAR DOUBLE MOBILITY LINER
• Manufacturer (Section D): MEDACTA INTERNATIONAL SA; strada regina; castel san pietro, 6874 ; SZ 6874
• MDR Report Key: 10507104
• Report Number: 3005180920-2020-00594
• Device Sequence Number: 3507605
• Product Code: MEH
• UDI-Device Identifier: 07630030807343
• UDI-Public: 07630030807343
• 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): 09/09/2020

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: 02/03/2025
• Device Model Number: 01.26.2852MHC
• Device Catalogue Number: 01.26.2852MHC
• Device Lot Number: 1910313
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/12/2020
• Initial Report FDA Received Date: 09/09/2020
• 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