MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA GMK-REVISION FIXED TIBIAL INSERT SC SIZE 3/10MM; FIXED TIBIAL INSERT SEMI-CONSTRAINED

Model Number	02.07.0310SCF
Health Effect - Clinical Code	Joint Laxity (4526)
Date of Event	12/27/2021
Type of Reportable Event	Serious Injury
Event or Problem Description
The patient had primary knee surgery on (b)(6) 2020.Subsequently, the patient came in reporting a lack of range of motion.The surgeon revised the femoral component and tibial insert on (b)(6) 2021.Presently, about 10 months after the previous revision surgery, the patient came in reporting mid-range instability and an inability to achieve full flexion.The surgeon revised the 10mm poly with a 14mm poly and revised the patella implant.The surgery was completed successfully.
Additional Manufacturer Narrative
Batch review performed on 28 december 2021.Lot 185109: (b)(4) items manufactured and released on 20-sep-2018.Expiration date: 2023-aug-30.No anomalies found related to the problem.To date, (b)(4) items of the same lot have been sold with no similar reported event.Additional implant involved: gmk-revision 02.07.0035rp patella resurfacing size 3 (k090988) lot.1909672.Batch review performed on 28 december 2021.Lot 1909672: (b)(4) items manufactured and released on 12-dec-2019.Expiration date: 2024-nov-30.No anomalies found related to the problem.To date, (b)(4) items of the same lot have been sold with no similar reported event.

• Brand Name: GMK-REVISION FIXED TIBIAL INSERT SC SIZE 3/10MM
• Common Device Name: FIXED TIBIAL INSERT SEMI-CONSTRAINED
• Manufacturer (Section D): MEDACTA INTERNATIONAL SA; strada regina; castel san pietro, 6874 ; SZ 6874
• Manufacturer (Section G): MEDACTA INTERNATIONAL SA; strada regina; castel san pietro, 6874 ; SZ 6874
• Manufacturer Contact: stefano baj ; strada regina; castel san pietro, switzerland 6874 ; SZ 6874
• MDR Report Key: 13333119
• Report Number: 3005180920-2022-00032
• Device Sequence Number: 13871338
• Product Code: JWH
• UDI-Device Identifier: 07630030817076
• UDI-Public: 07630030817076
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K103170
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2021
• Device Explanted Year: 2021
• 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): 01/24/2022

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 Expiration Date: 08/30/2023
• Device Model Number: 02.07.0310SCF
• Device Catalogue Number: 02.07.0310SCF
• Device Lot Number: 185109
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/27/2021
• Initial Report FDA Received Date: 01/24/2022
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 09/20/2018
• 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: 63 YR
• Patient Sex: Female
• Patient Race: White