MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA VERSAFITCUP DM 01.26.2852MHC DOUBLE MOBILITY HC LINER Ø 52/28; DOUBLE MOBILITY LINER

Model Number	01.26.2852MHC
Health Effect - Clinical Code	Unspecified Infection (1930)
Date of Event	10/05/2021
Type of Reportable Event	Serious Injury
Event or Problem Description
At 2 weeks after the primary surgery, the patient came in due to signs of an infection and the pathogen is unknown.The surgeon performed a washout and revised the poly and the surgery was completed successfully.
Additional Manufacturer Narrative
Batch review performed on 12.10.2021.Lot 2011779: (b)(4) items manufactured and released on 4-mar-2021.Expiration date: 2026-02-17.No anomalies found related to the problem.To date, (b)(4) items of the same lot have been sold without other similar reported event.

• Brand Name: VERSAFITCUP DM 01.26.2852MHC DOUBLE MOBILITY HC LINER Ø 52/28
• Common Device Name: DOUBLE MOBILITY LINER
• Manufacturer (Section D): MEDACTA INTERNATIONAL SA; strada regina; castel san pietro, 6874 ; SZ 6874
• Manufacturer (Section G): MEDACTA INTERNATIONAL SA; strada regina; castel san pietro, 6874 ; SZ 6874
• Manufacturer Contact: stefano baj ; strada regina; castel san pietro, switzerland 6874 ; SZ 6874
• MDR Report Key: 12750918
• Report Number: 3005180920-2021-00846
• Device Sequence Number: 14516614
• Product Code: MEH
• UDI-Device Identifier: 07630030807343
• UDI-Public: 07630030807343
• Combination Product (Y/N): N
• 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: 2021
• Device Explanted Year: 2021
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 11/04/2021

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: 02/17/2026
• Device Model Number: 01.26.2852MHC
• Device Catalogue Number: 01.26.2852MHC
• Device Lot Number: 2011779
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/05/2021
• Initial Report FDA Received Date: 11/04/2021
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 03/04/2021
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Female