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
Medical Device Problem Code	Migration (4003)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	05/02/2022
Type of Reportable Event	Serious Injury
Additional 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 or Problem 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.
Additional 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
• Common Device Name: 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
• Report Number: 3005180920-2022-00407
• Device Sequence Number: 14745484
• Product Code: HSX
• UDI-Device Identifier: 07630030896705
• UDI-Public: 07630030896705
• Combination Product (Y/N): N
• Initial Reporter Country: SZ
• PMA/510(K) Number: K162084
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2021
• Device Explanted Year: 2022
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 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
• Operator of Device: 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
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/02/2022
• Supplement Date Received by Manufacturer: 05/02/2022
• Initial Report FDA Received Date: 05/31/2022
• Supplement Report FDA Received Date: 07/14/2022
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 07/11/2018
• 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 Age: 70 YR
• Patient Sex: Female
• Patient Ethnicity: Non Hispanic
• Patient Race: White