MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA GMK-REVISION 02.07.0682L REVISION FIXED TIBIAL TRAY CEMENTED SIZE 2 L; KNEE TIBIAL TRAY CEMENTED

Model Number	02.07.0682L
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Scar Tissue (2060)
Date of Event	08/04/2022
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Batch review performed on 30-aug-2022.Lot 2008091: (b)(4) items manufactured and released on 17-nov-2020.Expiration date: 2025-10-28.No anomalies found related to the problem.To date, (b)(4) items of the same lot have been sold with no similar reported case during the period of review.Other devices involved: batch review performed on 30-aug-2022.Gmk-revision 02.07.0210psf tibial insert ps fixed size 2/10mm (k090988) lot 1910538: (b)(4) items manufactured and released on 05-feb-2020.Expiration date: 2025-01-21.No anomalies found related to the problem.To date, (b)(4) items of the same lot have been sold with no similar reported case during the period of review.Gmk-revision 02.07.2203l femur ps cemented size 3 l (k090988) lot 1906861: (b)(4) items manufactured and released on 05-nov-2019.Expiration date: 2024-10-22.No anomalies found related to the problem.To date, (b)(4) items of the same lot have been sold with no similar reported case during the period of review.
Event or Problem Description
At about 2 months after the primary surgery, the patient came in reporting stiffness in the knee due to the presence of scar tissue.The surgeon revised all components and the surgery was completed successfully.

• Brand Name: GMK-REVISION 02.07.0682L REVISION FIXED TIBIAL TRAY CEMENTED SIZE 2 L
• Common Device Name: KNEE TIBIAL TRAY CEMENTED
• 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: 15348723
• Report Number: 3005180920-2022-00659
• Device Sequence Number: 14738359
• Product Code: JWH
• UDI-Device Identifier: 07630030819346
• UDI-Public: 07630030819346
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K123721
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2022
• Device Explanted Year: 2022
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 09/02/2022

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 Model Number: 02.07.0682L
• Device Catalogue Number: 02.07.0682L
• Device Lot Number: 2008091
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/04/2022
• Initial Report FDA Received Date: 09/02/2022
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 11/17/2020
• 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