MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA VERSAFITCUP DM DOUBLE MOBILITY HC LINER Ø 58/28; HIP DOUBLE MOBILITY LINER

Model Number	01.26.2858MHC
Health Effect - Clinical Code	Unspecified Infection (1930)
Date of Event	01/05/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
The patient came in due to signs of an infection and the pathogen is unknown.The surgeon performed a washout and revised the head and liner 2 months after primary.The surgery was completed successfully.
Additional Manufacturer Narrative
Batch review performed on 31 january 2022: lot 2010829: (b)(4).Expiration date: 2025-11-15.No anomalies found related to the problem.(b)(4).Additional device involved.Batch review performed on 31 january 2022: mectacer 01.29.202 biolox delta ceramic ball head 12/14 ø 28 size m 0 (k112115) lot 2011654: (b)(4).Expiration date: 2026-02-11.No anomalies found related to the problem.(b)(4).

• Brand Name: VERSAFITCUP DM DOUBLE MOBILITY HC LINER Ø 58/28
• Common Device Name: HIP 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: 13415525
• Report Number: 3005180920-2022-00058
• Device Sequence Number: 3886192
• Product Code: LZO
• 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: 2021
• Device Explanted Year: 2022
• 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): 02/01/2022

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: 11/15/2025
• Device Model Number: 01.26.2858MHC
• Device Catalogue Number: 01.26.2858MHC
• Device Lot Number: 2010829
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/05/2022
• Initial Report FDA Received Date: 02/01/2022
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 11/25/2020
• 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: Required Intervention
• Patient Sex: Male