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

Catalog Number	01.26.2850MHC
Medical Device Problem Code	Device Dislodged or Dislocated (2923)
Health Effect - Clinical Code	Pain (1994)
Date of Event	08/11/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Batch review performed on 06-sep-2023.Lot 2236018: 55 items manufactured and released on 18-oct-2022.Expiration date: 2027-09-29.No anomalies found related to the problem.To date, 48 items of the same lot have been sold with no similar reported case during the period of review.Additional implant involved, batch review performed on 06-sep-2023.Cup: mpact 01.32.156mh acetabular shell ø56 multi-hole (k132879) lot 2213428: 32 items manufactured and released on 05-oct-2022.Expiration date: 2027-09-25.No anomalies found related to the problem.To date, 10 items of the same lot have been sold with no similar reported case during the period of review.
Event or Problem Description
The patient had a primary hip surgery on (b)(6) 2023.Soon after the primary hip surgery, the patient sustained a dislocation of the head from the liner.The surgeon revised all implants successfully.Presently, on (b)(6) 2023, the patient came in reporting pain due to joint luxation (dislocation of the head and liner from the cup) and the cause is unknown.The surgeon revised the head and liner successfully.

• Brand Name: VERSAFITCUP DM DOUBLE MOBILITY HC LINER Ø 50/28
• Common Device Name: HIP 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: 17690081
• Report Number: 3005180920-2023-00689
• Device Sequence Number: 6057726
• Product Code: MEH
• UDI-Device Identifier: 07630030807282
• UDI-Public: 07630030807282
• 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: 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): 09/06/2023

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: 2236018
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/11/2023
• Initial Report FDA Received Date: 09/06/2023
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 10/18/2022
• 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 Age: 69 YR
• Patient Sex: Male