MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA VERSAFITCUP DM DOUBLE MOBILITY HC LINER DIAM 50/28; HIP DOUBLE MOBILITY LINER

Catalog Number	01.26.2850MHC
Medical Device Problem Code	Device Appears to Trigger Rejection (1524)
Health Effect - Clinical Code	Unspecified Infection (1930)
Date of Event	08/27/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Batch review performed on 08 september 2023: lot 2239487: (b)(4) items manufactured and released on 04-nov-2022.Expiration date: 2027-10-18.No anomalies found related to the problem.To date, (b)(4) items of the same lot have been sold with another similar reported event during the period of review.
Event or Problem Description
Hold ps 9/20.The patient had a primary hip surgery on (b)(6) 2022.On (b)(6) 2022, the patient came in reporting pain due to a fractured femur that was caused from falling and twisting the leg.The surgeon cabled the fracture and revised the stem, head, and liner.The surgery was completed successfully.On (b)(6) 2023, the patient came in reporting pain due to a fractured femur that was caused from falling.The surgeon cabled the fracture and revised the stem and head with competitor products and revised the medacta liner with a medacta liner.The surgery was completed successfully.Presently, on (b)(6) 2023, the patient came in due to signs of an infection and the pathogen is unknown.The surgeon performed a washout and revised the liner.The surgery was completed successfully.

• Brand Name: VERSAFITCUP DM DOUBLE MOBILITY HC LINER DIAM 50/28
• Common Device Name: HIP DOUBLE MOBILITY LINER
• Manufacturer (Section D): MEDACTA INTERNATIONAL SA; strada regina; castel san pietro, switzerland 6874 ; SZ 6874
• Manufacturer (Section G): MEDACTA INTERNATIONAL SA; strada regina; castel san pietro, switzerland 6874 ; SZ 6874
• Manufacturer Contact: marco giannessi ; strada regina; castel san pietro, switzerland 6874 ; SZ 6874
• MDR Report Key: 17779918
• Report Number: 3005180920-2023-00748
• Device Sequence Number: 5492968
• Product Code: MEH
• UDI-Device Identifier: 07630030807282
• UDI-Public: 07630030807282
• Combination Product (Y/N): N
• Initial Reporter State: MO
• Initial Reporter Country: US
• PMA/510(K) Number: K092265
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2023
• Device Explanted Year: 2023
• 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): 09/20/2023

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 Catalogue Number: 01.26.2850MHC
• Device Lot Number: 2239487
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/27/2023
• Initial Report FDA Received Date: 09/20/2023
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 11/04/2022
• 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: Female