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

Model Number	01.26.2852MHC
Health Effect - Clinical Code	Unspecified Infection (1930)
Date of Event	11/30/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Batch review performed on 11 december 2020 lot 2001457: 110 items manufactured and released on 23-jun-2020.Expiration date: 2025-06-02.No anomalies found related to the problem.To date, 61 items of the same lot have been already sold without any similar reported event.Additional item involved in the event: ball heads: cocr 01.25.011 cocr ball head 12/14 ø 28 size s -3.5 (k072857) lot.2001935 batch review performed on 11 december 2020 lot 2001935: 120 items manufactured and released on 22-jun-2020.Expiration date: 2025-06-08.No anomalies found related to the problem.To date, 49 items of the same lot have been already sold without any similar reported event.
Event or Problem Description
The patient came in after 1 month from the 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 52/28
• Common Device Name: DOUBLE MOBILITY LINER
• Manufacturer (Section D): MEDACTA INTERNATIONAL SA; strada regina; castel san pietro, 6874 ; SZ 6874
• MDR Report Key: 11037519
• Report Number: 3005180920-2020-00956
• Device Sequence Number: 16470674
• 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): Unknown
• Reporter Type: Manufacturer
• Report Source: other
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 12/18/2020

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: 02/06/2025
• Device Model Number: 01.26.2852MHC
• Device Catalogue Number: 01.26.2852MHC
• Device Lot Number: 2001457
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/30/2020
• Initial Report FDA Received Date: 12/18/2020
• 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