MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA GMK-REVISION 02.07.FCL14065 EXTENSION STEM - FLUTED Ø 14 L 65; KNEE EXTENSION STEM

Catalog Number 02.07.FCL14065

Device Problem Migration (4003)

Patient Problem Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)

Event Date 11/30/2023

Event Type  Injury  

Event Description

About 5 years and 11 months after the primary surgery, revision surgery was performed to remove the screw of the extension stem that was unscrewed.Fixation screw removed and replaced with a new one and liner revised per standard procedure.

Manufacturer Narrative

Batch review performed on 4 december 2023.Lot 162541: (b)(4) items manufactured and released on 05-sep-2016.Expiration date: 2021-aug-24.No anomalies found related to the problem.To date, all items of the same lot have been sold with no similar reported event during the period of review.

Manufacturer Narrative

On the 28th february 2024 medacta international was informed that the devices are not available.

Manufacturer Narrative

Clinical evaluation performed by clinical affairs department on (b)(6) 2024.6 years after semiconstrained cemented tka in a very difficult patient, the femoral stem fixation screw is found loose in the joint at radiographic control.Surgery is undertaken to remove the loose screw and replace it with a new one.As per standard procedure, the tibial insert is also exchanged to a new one.The cause for screw backout cannot be determined with certainty.A probable cause is insufficient tightening torque at the time of primary surgery: this is a condition, reproducible in the laboratory, that can cause self-unscrewing.A torque-limiting device is available to make sure that the screw is tightened at the right torque, but according to report, it is unclear if it had been used at the time of index surgery.

• Brand Name: GMK-REVISION 02.07.FCL14065 EXTENSION STEM - FLUTED Ø 14 L 65
• Type of Device: KNEE EXTENSION STEM
• 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: marco giannessi ; strada regina; castel san pietro, switzerland 6874 ; SZ 6874
• MDR Report Key: 18382649
• MDR Text Key: 331184423
• Report Number: 3005180920-2023-01021
• Device Sequence Number: 1
• Product Code: JWH
• UDI-Device Identifier: 07630030822964
• UDI-Public: 07630030822964
• Combination Product (y/n): N
• Reporter Country Code: AU
• PMA/PMN Number: K120790
• 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,Followup,Followup
• Report Date: 03/28/2024

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: 08/24/2021
• Device Catalogue Number: 02.07.FCL14065
• Device Lot Number: 162541
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 11/30/2023
• Initial Date FDA Received: 12/22/2023
• Supplement Dates Manufacturer Received: 11/30/2023; 11/30/2023
• Supplement Dates FDA Received: 01/31/2024; 03/28/2024
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 09/05/2016
• 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
• Patient Age: 75 YR
• Patient Sex: Female
• Patient Ethnicity: Non Hispanic
• Patient Race: White