MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA GMK-REVISION FIXED TIBIAL INSERT SC SIZE 3/12MM; KNEE TIBIAL INSERT

Catalog Number	02.07.0312SCF
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Loss of Range of Motion (2032)
Date of Event	03/18/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
At about 6 years and 2 months after the previous revision surgery (when medacta gmk revision components have been implanted), the patient came in reporting stiffness in the knee and the cause is unknown.The surgeon revised all components to hinge components and the surgery was completed successfully.Patient had competitor components prior to medacta revision components.
Additional Manufacturer Narrative
Batch review performed on 20-mar-2024: lot 134132: (b)(4) items manufactured and released on 06-dec-2013.Expiration date: 2018-10-31.No anomalies found related to the problem.To date, (b)(4) items of the same lot have been sold with another similar reported event during the period of review.Additional implants involved, batch review performed on 20-mar-2024: gmk-revision 02.07.0683l revision fixed tibial tray cemented size 3 l (k123721) lot 172154: (b)(4) items manufactured and released on 04-aug-2017.Expiration date: 2022-07-24.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.Gmk-revision 02.07.2403l femur revision ps size 3 l (k102437) lot 154240: (b)(4) items manufactured and released on 26-aug-2015.Expiration date: 2020-07-19.No anomalies found related to the problem.To date, all the items of the same lot have been sold with no similar reported event during the period of review.

• Brand Name: GMK-REVISION FIXED TIBIAL INSERT SC SIZE 3/12MM
• Common Device Name: KNEE TIBIAL INSERT
• 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: 19085909
• Report Number: 3005180920-2024-00199
• Device Sequence Number: 7102981
• Product Code: JWH
• UDI-Device Identifier: 07630030817175
• UDI-Public: 07630030817175
• Combination Product (Y/N): N
• Initial Reporter State: MO
• Initial Reporter Country: US
• PMA/510(K) Number: K103170
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2018
• Device Explanted Year: 2024
• 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): 04/11/2024

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: 10/31/2018
• Device Catalogue Number: 02.07.0312SCF
• Device Lot Number: 134132
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/18/2024
• Initial Report FDA Received Date: 04/11/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 12/06/2023
• 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: Female