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

Catalog Number 02.18.TF2.LM

Device Problem Migration (4003)

Patient Problem Insufficient Information (4580)

Event Type  Injury  

Event Description

Revision surgery for tibial tray subsidence, no additional info available.

Manufacturer Narrative

Clinical evaluation performed by medical affairs director subsidence of the tibial component in a 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 factors may have influenced, such as the advanced age of the patient, although the bone quality appears radiographically to be rather good.The definitive cause for subsidence cannot be identified with the information at hand.

• Brand Name: MOTO PARTIAL KNEE TIBIAL TRAY FIX CEMENTED S2 LM
• Type of Device: UNICOMPARTIMENTAL 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: 18950298
• MDR Text Key: 338251330
• Report Number: 3005180920-2024-00137
• Device Sequence Number: 1
• Product Code: HSX
• UDI-Device Identifier: 07630030896712
• UDI-Public: 07630030896712
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K162084
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Company Representative
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 03/21/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/21/2024
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: 02.18.TF2.LM
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 02/20/2024
• Was Device Evaluated by Manufacturer?: No
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 83 YR
• Patient Sex: Female
• Patient Ethnicity: Non Hispanic
• Patient Race: White