MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA MOTO PARTIAL KNEE TIBIAL TRAY FIX CEMENTED S2 RM

Catalog Number	02.18.TF2.RM
Medical Device Problem Code	Migration or Expulsion of Device (1395)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/26/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Batch review performed on 06 october 2023.Lot 2108661:(b)(4) items manufactured and released on 29-sep-2021.Expiration date: 2026-09-15.No anomalies found related to the problem.To date, (b)(4) items of the same lot have been sold without any similar reported event during the period of review.Clinical evaluation performed by medical affairs deparment: a revision surgery was conducted 2 months after the first implant of a moto partial knee.No clinical infromation are reported about the patient.The reported reason for revision is implant failure due to poor bone quality (detected during a follow up check).We have only one projection x-ray available, where we can assess subsidence and probably a posterior migration of the tibial component.Among the causes of this kind of failure, there is certainly the poor quality of the bone (as declared in the report).However, with the information at hand it is diffcult to determine whether other causes occured (such as malpoisitioning, undesizing, trauma, intraoperative issues during the cementation phase.).We have no reason to suspect a malfunctioning device.The revision surgery provided the implant of a tka (gmk sphere) and it completed successfully.
Event or Problem Description
Revision surgery was performed at about 2 months after the primary due to cemented tibial tray subsidence.Moto components have been successfully revised.The patient has poor bone quality.

• Brand Name: MOTO PARTIAL KNEE TIBIAL TRAY FIX CEMENTED S2 RM
• Common Device Name: KNEE TIBIAL TRAY
• 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: 18002681
• Report Number: 3005180920-2023-00839
• Device Sequence Number: 15351691
• Product Code: HSX
• UDI-Device Identifier: 07630030896729
• UDI-Public: 07630030896729
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K162084
• 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: Other
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 10/25/2023

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 Expiration Date: 09/15/2026
• Device Catalogue Number: 02.18.TF2.RM
• Device Lot Number: 2108661
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/26/2023
• Initial Report FDA Received Date: 10/25/2023
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 09/29/2019
• 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: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Female