MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA VERSAFITCUP DM TRIAL LINER MONOBLOC DMF-M; INSTRUMENT FOR HIP SURGERY

Catalog Number	01.26.10.0314
Medical Device Problem Code	Appropriate Device Problem Term/Code Not Available (3191)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	08/16/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Batch review performed on 19 august 2024: lot 1954280: (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.Investigation performed by medacta r&d hip project manager on 3 september 2024: from the received images, no additional information related to the event can be obtained, except that the part appears visibly worn, probably due to the high usage of the component.It is not possible to determine with certainty the root cause of the event, but a possible reason could be an excessive wear of the instrument together with a suboptimal handling/maintenance of the instrument (during transport or washing), or forces applied on the metal component during the usage.
Event or Problem Description
The trial liner monobloc dmf-mmetal ring came off during hip trailing.The trial could still be used but was not easily identifiable during x-ray for orientation.Surgery completed successfully.

• Brand Name: VERSAFITCUP DM TRIAL LINER MONOBLOC DMF-M
• Common Device Name: INSTRUMENT FOR HIP SURGERY
• 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: 20155191
• Report Number: 3005180920-2024-00716
• Device Sequence Number: 11824057
• Product Code: LXH
• UDI-Device Identifier: 07630971246010
• UDI-Public: 07630971246010
• 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
• Report Date (Section B): 09/06/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Catalogue Number: 01.26.10.0314
• Device Lot Number: 1954280
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/16/2024
• Initial Report FDA Received Date: 09/06/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 05/15/2019
• Is the Device Labeled for Single Use? (Y/N): No
• 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: Other
• Patient Age: 53 YR
• Patient Sex: Male
• Patient Weight: 90 KG
• Patient Race: White