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

Model Number 02.18.TF1.RM

Device Problems Appropriate Term/Code Not Available (3191); Loosening of Implant Not Related to Bone-Ingrowth (4002)

Patient Problem Inadequate Osseointegration (2646)

Event Date 05/25/2021

Event Type  Injury  

Manufacturer Narrative

Batch review performed on 31 may 2021: lot 170788: (b)(4) items manufactured and released on 05-apr-2017.Expiration date: 2022-03-28.No anomalies found related to the problem.To date, (b)(4) items of the same lot have been already sold without any other similar reported event.Clinical evaluation: 1.5 years after primary uka the tibial component loosened and required revision.From the radiographs supplied, it seems that the medial proximal tibial bone lost density and became unable to sustain the baseplate, for unknown reasons.According to the surgeon's analysis, the baseplate could not be seated fully on cortical bone, particularly it did not reach the anterior tibial cortex.This is of course a good explanation, but the images we have available are not sufficient for us to confirm this hypothesis.We don't see any reason to suspect a faulty implant.

Event Description

Revision due to aseptic loosening of the tibial component 1 year and 4 months after primary.All devices were explanted and gmk sphere system was implanted.It may be that the anterior part of the tibial implant was not perfectly seated on the cortical bone.The patient has a rather high bmi.

• Brand Name: MOTO PARTIAL KNEE TIBIAL TRAY FIX CEMENTED S1 RM
• Type of Device: FIXED CEMENTED 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: 12058170
• MDR Text Key: 258293464
• Report Number: 3005180920-2021-00507
• 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
• Report Date: 06/24/2021

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: 03/28/2022
• Device Model Number: 02.18.TF1.RM
• Device Catalogue Number: 02.18.TF1.RM
• Device Lot Number: 170788
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 05/25/2021
• Initial Date FDA Received: 06/24/2021
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 04/05/2017
• 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: 69 YR