MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA MOTO PARTIAL KNEE TIBIAL INSERT FIX S3 RM - 10MM

Model Number 02.18.IF3.10.RM

Device Problem Activation, Positioning or Separation Problem (2906)

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

Event Date 08/05/2021

Event Type  malfunction  

Manufacturer Narrative

Batch review performed on 06 august 2021: lot 189277: (b)(4) items manufactured and released on 11-apr-2019.Expiration date: 2024-march-27.No anomalies found related to the problem.To date, (b)(4) items of the same lot have been sold without any similar reported event.Additional devices involved: batch reviews performed on 06 august 2021: moto partial knee 02.18.If3.11.Rm tibial insert fix s3 rm - 11mm lot.189278 (k162084) lot 189278: (b)(4) items manufactured and released on 11-apr-2019.Expiration date: 2024-march-27.No anomalies found related to the problem.To date, (b)(4) item of the same lot have been sold without any similar reported event.Moto partial knee 02.18.If3.09.Rm tibial insert fix s3 rm - 9mm (k162084) lot 2009904: (b)(4) items manufactured and released on 14-dic-2020.Expiration date: 2025-nov-30.No anomalies found related to the problem.To date, (b)(4) item of the same lot have been sold without any similar reported event.Moto partial knee 02.18.Tf3.Rm tibial tray fix cemented s3 rm (k162084) lot 2009938: (b)(4) items manufactured and released on 01-march-2021.Expiration date: 2026-feb-17.No anomalies found related to the problem.To date, (b)(4) items of the same lot have been sold without any similar reported event.Visual inspection performed by medacta knee r&d manager: some incisions and scratches can be seen on the distal surface of the returned tibial inserts, most likely caused during the attempt to extract the inserts from the joint.One of the 2 inserts presents the posterior feature of the snapping mechanism (posterior protusion intended to be seated in the baseplate) slightly damaged, with a sort of incision of the negative shape of the edge of the baseplate.This was most likely caused during the attempt to snap the insert into the baseplate with the insert not properly positioned.The second insert doesn't present any damages on the features of the snapping mechanism.A functional test has been performed in medacta to verify the snapping mechanism of the insert and its stability when fixed to the baseplate, using a dedicated gauge (e04720).Test has been successfully passed without revealing any malfunctioning for both the returned inserts.From visual inspection there is no evidence that the event is related to a faulty device.From event description, it is not clear if the 'mobility' of the insert in the joint was due to the fact that it was not properly engaged in the baseplate or if it was just related to the feeling of the surgeon in his first experiences with this implant.

Event Description

The 10mm insert was not rigidly fixed to the base plate.It was easy to disengage when the surgeon lightly pushed it with the instrument.After many attempts, the situation did not change.The surgeon tried an 9mm and a 11mm insert and the problem re-occured.Finally, the 11 mm insert was inserted and the surgery was completed successfully.No patient harm, about 40 minutes delay.

• Brand Name: MOTO PARTIAL KNEE TIBIAL INSERT FIX S3 RM - 10MM
• Type of Device: KNEE TIBIAL INSERT
• 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: 12413797
• MDR Text Key: 271538569
• Report Number: 3005180920-2021-00700
• Device Sequence Number: 1
• Product Code: HSX
• UDI-Device Identifier: 07630030896026
• UDI-Public: 07630030896026
• Combination Product (y/n): N
• Reporter Country Code: JA
• 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: 09/02/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/02/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 03/27/2024
• Device Model Number: 02.18.IF3.10.RM
• Device Catalogue Number: 02.18.IF3.10.RM
• Device Lot Number: 189277
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/25/2021
• Date Manufacturer Received: 08/05/2021
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/11/2019
• 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): Other
• Patient Age: 76 YR