MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA MOTO PARTIAL KNEE 02.18.TF1.LM TIBIAL TRAY FIX CEMENTED S1 LM; KNEE TIBIAL TRAY FIX CEMENTED

Catalog Number	02.18.TF1.LM
Medical Device Problem Code	Migration or Expulsion of Device (1395)
Health Effect - Clinical Code	Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available (4581)
Date of Event	02/23/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Batch review performed on 29 february 2024 lot 2302384: (b)(4) items manufactured and released on 15-jun-2023.Expiration date: 2028-05-29.No anomalies found related to the problem.To date, (b)(4) items of the same lot have been sold with no similar reported event during the period of review.Clinical evaluation performed by medical affairs director: subsidence of the tibial component in a cemented medial uka.Date of primary surgery unspecified.Presumably the adverse event took place shortly after index operation.Apparently, the bone coverage was insufficient to offer adequate primary stability.This may be due to difficulties in size selection or placement of the component, but of course other patient-specific factors, as well as postoperative protocol, may have influenced, although the bone quality appears radiographically to be rather good.The definitive cause for subsidence cannot be identified with the information at hand.
Event or Problem Description
Revision surgery for tibial tray subsidence.All implants were removed and gmk revision with semiconstrainted liner was implanted successfully.

• Brand Name: MOTO PARTIAL KNEE 02.18.TF1.LM TIBIAL TRAY FIX CEMENTED S1 LM
• Common Device Name: KNEE TIBIAL TRAY FIX CEMENTED
• 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: 18950504
• Report Number: 3005180920-2024-00136
• Device Sequence Number: 17913536
• Product Code: HSX
• UDI-Device Identifier: 07630030896699
• UDI-Public: 07630030896699
• Combination Product (Y/N): N
• Initial Reporter Country: IT
• PMA/510(K) Number: K162084
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Explanted Year: 2024
• 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): 03/21/2024

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?: No
• Operator of Device: Health Professional
• Device Catalogue Number: 02.18.TF1.LM
• Device Lot Number: 2302384
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/20/2024
• Initial Report FDA Received Date: 03/21/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 06/15/2023
• 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
• Patient Ethnicity: Non Hispanic
• Patient Race: White