MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA MOTO PARTIAL KNEE TIBIAL TRAY FIX CEMENTED S4 RM; KNEE TIBIAL TRAY CEMENTED

Model Number 02.18.TF4.RM

Device Problem Loosening of Implant Not Related to Bone-Ingrowth (4002)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 12/12/2022

Event Type  Injury  

Manufacturer Narrative

Batch review performed on 15 december 2022: lot 2001395: 30 items manufactured and released on 29-may-2020.Expiration date: 2025-05-21.No anomalies found related to the problem.To date, all the items of the same lot have been sold without any similar reported event in the period of review.Additional involved implant: batch review of moto partial knee 02.18.004rm anatomical femoral component cemented s4 rm (k162084) lot.2004506 performed on 15 december 2022: lot 2004506: 41 items manufactured and released on 10-jul-2020.Expiration date: 2025-07-03.No anomalies found related to the problem.To date, all the items of the same lot have been sold without any similar reported event in the period of review.

Event Description

At about 2 years and 1 month post primary, revision surgery for moto tibia and femur (medial) implants loosening.Gmk sphere implanted successfully.

• Brand Name: MOTO PARTIAL KNEE TIBIAL TRAY FIX CEMENTED S4 RM
• Type of Device: KNEE TIBIAL TRAY 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: stefano baj ; strada regina; castel san pietro, switzerland 6874 ; SZ 6874
• MDR Report Key: 16139959
• MDR Text Key: 307113882
• Report Number: 3005180920-2022-00972
• Device Sequence Number: 1
• Product Code: HSX
• UDI-Device Identifier: 07630030896767
• UDI-Public: 07630030896767
• 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
• Report Date: 01/11/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/11/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 02.18.TF4.RM
• Device Catalogue Number: 02.18.TF4.RM
• Device Lot Number: 2001395
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 12/12/2022
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 05/29/2020
• 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: 72 YR
• Patient Sex: Male