MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA VERSAFITCUP GENERAL TRIAL LINER MONOBLOC DMI-M; ACETABULAR TRIAL LINER

Catalog Number	01.26.10.0317
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	04/17/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Batch review performed on 25-apr-2024 lot 1954266: (b)(4) items manufactured and released on 15-may-2019.No anomalies found related to the problem.To date, no other similar events have been reported on the same lot during the period of review.Preliminary investigation performed by r&d project manager from the received information, it is possible to see the x-ray and image of the metal ring.It was not possible to determine with certainty the root cause of the event, but a probable reason is that a movement levering with instruments, bone, or soft tissue could have caused the detachment of the metal ring from the trial liner.The ring was particularly required in order to see the trial liner with fluoroscopy during trial reduction: however, it was possible to see its detachment thanks to its radiopacity.This type of event will be continuously monitored.
Event or Problem Description
The post-operative x-ray revealed that the metal ring of the trial liner monobloc detached and remained in the patient.An additional surgery was necessary to remove the metal piece.
Event or Problem Description
The post-operative x-ray revealed that the metal ring of the trial liner monobloc detached and remained in the patient.An additional surgery was necessary to remove the metal piece, performed the same day.
Additional Manufacturer Narrative
Batch review performed on 24-may-2024 lot 1954286: 6 items manufactured and released on 13-may-2019.No anomalies found related to the problem.To date, no other similar events have been reported on the same lot during the period of review.Visual inspection performed by r&d project manager the trial liner monobloc dmi-m is composed by a plastic monobloc and a metal ring, the metal ring was missed, it was not received for inspection.The plastic monobloc had not visible signs of defects, some measurements were taken showing that no visible deformations occurred.It is not possible to determine with certainty the root cause of the event, but it is possible that, during its use in surgery or during manual operations (transport, cleaning etc.), the contacts with other part could have moved and deformed the ring causing then the issue reported.

• Brand Name: VERSAFITCUP GENERAL TRIAL LINER MONOBLOC DMI-M
• Common Device Name: ACETABULAR TRIAL 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: 19371342
• Report Number: 3005180920-2024-00316
• Device Sequence Number: 7703246
• Product Code: LXH
• UDI-Device Identifier: 07630971246362
• UDI-Public: 07630971246362
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 06/20/2024

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?: Yes
• Operator of Device: Health Professional
• Device Catalogue Number: 01.26.10.0317
• Device Lot Number: 1954286
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/24/2024
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 05/22/2024
• Supplement Report FDA Received Date: 06/20/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/13/2019
• 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: Reuse
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 79 YR
• Patient Sex: Female