MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA GMK-REVISION FEMUR REVISION PS SIZE 6 L; KNEE CEMENTED FEMORAL COMPONENT

Model Number	02.07.2406L
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Joint Laxity (4526)
Date of Event	01/12/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Batch review performed on 16 december 2023.Lot 189958: (b)(4) items manufactured and released on 15-jan-2019.Expiration date: 2023-12-18.No anomalies found related to the problem.To date, (b)(4) items of the same lot have been sold without any similar reported event during the period of review.Clinical evaluation performed by medical affairs department: two years after primary tka, the patient reports on developmental instability and a new surgeon decides to replace the primary knee with a constrained device.Having no further information we cannot make a precise evaluation of the case, but if the new surgeon decided to go for a constrained device it most probably was a problem of ligament insufficiency, not a problem of instability caused by the existing implant.Additional involved implants batch review performed on 16 december 2023 on gmk-revision 02.07.0684l revision fixed tibial tray cemented size 4 l (k123721) lot.1904783.Lot 1904783: (b)(4) items manufactured and released on 05-nov-2019.Expiration date: 2024-10-(b)(4).No anomalies found related to the problem.To date, (b)(4) items of the same lot have been sold without any similar reported event during the period of review.Batch review performed on 16 january 2023 on gmk-revision 02.07.0414scf fixed tibial insert sc size 4/14mm (k103170) lot.189540.Lot 189540: (b)(4)items manufactured and released on 11-march-2019.Expiration date: 2024-02-26.No anomalies found related to the problem.To date, (b)(4) items of the same lot have been sold without any similar reported event during the period of review.
Event or Problem Description
At about 2 years 1 month after, the patient came in reporting instability and the cause is unknown.The surgeon revised all components with hinge components and the surgery was completed successfully.

• Brand Name: GMK-REVISION FEMUR REVISION PS SIZE 6 L
• Common Device Name: KNEE CEMENTED FEMORAL COMPONENT
• 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: stefano baj ; strada regina; castel san pietro, switzerland 6874 ; SZ 6874
• MDR Report Key: 16350865
• Report Number: 3005180920-2023-00059
• Device Sequence Number: 12327368
• Product Code: JWH
• UDI-Device Identifier: 07630030821462
• UDI-Public: 07630030821462
• Combination Product (Y/N): N
• Initial Reporter State: IL
• Initial Reporter Country: US
• PMA/510(K) Number: K102437
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2020
• Device Explanted Year: 2023
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 02/10/2023

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: 12/18/2023
• Device Model Number: 02.07.2406L
• Device Catalogue Number: 02.07.2406L
• Device Lot Number: 189958
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/12/2023
• Initial Report FDA Received Date: 02/10/2023
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 01/15/2019
• 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 Sex: Unknown