MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA MOTO PARTIAL KNEE TIBIAL TRAY FIX CEMENTED S1 RM; KNEE UNICOMPARTIMENTAL TIBIAL TRAY CEMENTED

Model Number 02.18.TF1.RM

Device Problem Migration (4003)

Patient Problem Insufficient Information (4580)

Event Date 05/02/2022

Event Type  Injury  

Manufacturer Narrative

Batch review performed on 03 may 2022: lot 182120: (b)(4) items manufactured and released on 11-july-2018.Expiration date: 2023-06-20.No anomalies found related to the problem.To date, (b)(4) items of the same lot have been sold without any similar reported event.Clinical evaluation performed by medical affairs department.Few months after primary uka in a largely overweight patient, the tibial bone gives way and the baseplate subsides.Substitution to a total knee becomes necessary.This inconvenience was not related to a device defect or malfunction.

Event Description

Revision surgery at 7 months from primary for tibial implant subsidence.The subsidence is likely due to patient weight and insufficient bone stability.All implants were revised and gmk sphere was implanted.

Manufacturer Narrative

Devices not available anymore, as reported by the sales agent on 14 june 2022.

• Brand Name: MOTO PARTIAL KNEE TIBIAL TRAY FIX CEMENTED S1 RM
• Type of Device: KNEE UNICOMPARTIMENTAL TIBIAL TRAY CEMENTED
• Manufacturer (Section D): MEDACTA INTERNATIONAL SA; strada regina; castel san pietro, 6874 ; SZ 6874
• Manufacturer (Section G): MEDACTA INTERNATIONAL SA; strada regina; castel san pietro, 6874 ; SZ 6874
• Manufacturer Contact: stefano baj ; strada regina; castel san pietro, switzerland 6874 ; SZ 6874
• MDR Report Key: 14545852
• MDR Text Key: 292956409
• Report Number: 3005180920-2022-00407
• Device Sequence Number: 1
• Product Code: HSX
• UDI-Device Identifier: 07630030896705
• UDI-Public: 07630030896705
• Combination Product (y/n): N
• Reporter Country Code: SZ
• 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,Followup
• Report Date: 07/14/2022

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
• Device Operator: Health Professional
• Device Expiration Date: 06/20/2023
• Device Model Number: 02.18.TF1.RM
• Device Catalogue Number: 02.18.TF1.RM
• Device Lot Number: 182120
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: 05/02/2022
• Initial Date FDA Received: 05/31/2022
• Supplement Dates Manufacturer Received: 05/02/2022
• Supplement Dates FDA Received: 07/14/2022
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 07/11/2018
• 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: 70 YR
• Patient Sex: Female
• Patient Ethnicity: Non Hispanic
• Patient Race: White