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

Model Number	01.26.2852MHC
Health Effect - Clinical Code	Unspecified Infection (1930)
Date of Event	02/04/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Batch review performed on 16 february 2021: lot 1909378: (b)(4) items manufactured and released on 22-jan-2020.Expiration date: 2024-12-14.No anomalies found related to the problem.To date, (b)(4) items of the same lot have been already sold with another similar event reported.Additional implant involved: cup: mpact 01.32.152mb double mobility acetabular shell ø52 (k143453) lot.180082.Batch review performed on 16 february 2021: lot 180082: (b)(4) items manufactured and released on 20-june-2018.Expiration date: 2023-06-11.No anomalies found related to the problem.To date, (b)(4) items of the same lot have been already sold without any other similar reported event.
Event or Problem Description
The patient had primary hip surgery on (b)(6) 2018.On (b)(6) 2021, the patient came in reporting pain due to a loose stem.Stem and head were revised with competitor products and medacta liner was revised with a medacta liner.Presently, on (b)(6) 2021, the patient came in due to signs of an infection and the pathogen is unknown.The surgeon performed a washout, removed all components, and implanted an antibiotic spacer, 1 month after the previous surgery.The surgery was completed successfully.

• Brand Name: LINER: VERSAFITCUP DM DOUBLE MOBILITY HC LINER 52/28
• Common Device Name: DOUBLE MOBILITY ACETABULAR LINER
• Manufacturer (Section D): MEDACTA INTERNATIONAL SA; strada regina; castel san pietro, 6874 ; SZ 6874
• MDR Report Key: 11410384
• Report Number: 3005180920-2021-00171
• Device Sequence Number: 19937655
• 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: 2021
• Device Explanted Year: 2021
• 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): 03/04/2021

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: 12/14/2024
• Device Model Number: 01.26.2852MHC
• Device Catalogue Number: 01.26.2852MHC
• Device Lot Number: 1909378
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/04/2021
• Initial Report FDA Received Date: 03/04/2021
• 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