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
Medical Device Problem Code	Migration (4003)
Health Effect - Clinical Code	Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available (4581)
Date of Event	11/30/2023
Type of Reportable Event	Serious Injury
Event or Problem 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.
Additional 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.
Additional Manufacturer Narrative
On the 28th february 2024 medacta international was informed that the devices are not available.
Additional 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
• Common Device Name: 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
• Report Number: 3005180920-2023-01021
• Device Sequence Number: 15403081
• Product Code: JWH
• UDI-Device Identifier: 07630030822964
• UDI-Public: 07630030822964
• Combination Product (Y/N): N
• Initial Reporter Country: AU
• PMA/510(K) Number: K120790
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2017
• Device Explanted Year: 2023
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 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
• Operator of Device: Health Professional
• Device Expiration Date: 08/24/2021
• Device Catalogue Number: 02.07.FCL14065
• Device Lot Number: 162541
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/30/2023
• Supplement Date Received by Manufacturer: 11/30/2023; 11/30/2023
• Initial Report FDA Received Date: 12/22/2023
• Supplement Report FDA Received Date: 01/31/2024; 03/28/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 09/05/2016
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 75 YR
• Patient Sex: Female
• Patient Ethnicity: Non Hispanic
• Patient Race: White