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

Model Number	01.26.2858MHC
Health Effect - Clinical Code	Joint Dislocation (2374)
Date of Event	01/07/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Batch review performed on 15 january 2020: lot 1902877: (b)(4) items manufactured and released on 21-jun-2019.Expiration date: 2025-06-05.No anomalies found related to the problem.To date, (b)(4) items of the same lot have been already sold without any similar reported event.
Event or Problem Description
The patient had a primary hip surgery and was implanted with competitor items.The date of the primary surgery is unknown.Subsequently on (b)(6) 2019, the patient came in due to metallosis in the hip.The surgeon revised the patient with a medacta liner.Presently, on (b)(6) 2020, about 2 months after primary, the patient came in reporting pain due to a dislocation of the head from the liner.The surgeon revised the competitor head and medacta liner.

• Brand Name: LINER: VERSAFITCUP DM DOUBLE MOBILITY HC LINER 28/DMI
• Common Device Name: DOUBLE MOBILITY HC LINER
• Manufacturer (Section D): MEDACTA INTERNATIONAL SA; strada regina; castel san pietro, 6874 ; SZ 6874
• MDR Report Key: 9675221
• Report Number: 3005180920-2020-00023
• Device Sequence Number: 2837115
• Product Code: MEH
• 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: 2019
• Device Explanted Year: 2020
• Reporter Type: Manufacturer
• Report Source: other
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 02/06/2020

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: 06/05/2025
• Device Model Number: 01.26.2858MHC
• Device Catalogue Number: 01.26.2858MHC
• Device Lot Number: 1902877
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/07/2020
• Initial Report FDA Received Date: 02/06/2020
• 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