MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA MOTO PARTIAL KNEE TIBIAL TRAY FIX CEMENTED S5 LM; UNICOMPARTIMENTAL TIBIAL TRAY

Catalog Number 02.18.TF5.LM

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

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 11/13/2019

Event Type  Injury  

Manufacturer Narrative

Batch review performed on 22 november 2019: lot 160693: 61 items manufactured and released on 21-oct-2016.Expiration date: 2021-05-26.No anomalies found related to the problem.To date, 60 items of the same lot have been already sold without any similar reported event.Clinical evaluation performed by medical affairs director: few months after primary cemented uka the anterior aspect of the tibial bone gave in and the tibial component subsided and mobilized.Reportedly, this was due to the patient's hypogonadism and poor bone quality.No reason to suspect a faulty device to be responsible for this adverse event.

Event Description

About 8 months after primary revision surgery for tibial implant subsidence.The surgery was completed successfully.All hardware revised and gmk-sphere implanted.

• Brand Name: MOTO PARTIAL KNEE TIBIAL TRAY FIX CEMENTED S5 LM
• Type of Device: UNICOMPARTIMENTAL TIBIAL TRAY
• 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: 9436672
• MDR Text Key: 170641208
• Report Number: 3005180920-2019-01041
• Device Sequence Number: 1
• Product Code: HSX
• UDI-Device Identifier: 07630030896774
• UDI-Public: 07630030896774
• 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: 12/09/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/09/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 05/26/2021
• Device Catalogue Number: 02.18.TF5.LM
• Device Lot Number: 160693
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 11/13/2019
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 10/21/2016
• 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