MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA GMK-REVISION FIXED TIBIAL INSERT SC SIZE 3/26MM; KNEE TIBIAL INSERT

Model Number	02.07.0326SCF
Health Effect - Clinical Code	Muscle/Tendon Damage (4532)
Date of Event	11/05/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Batch review performed on 12 november 2021: lot 1904799: (b)(4) items manufactured and released on 5-lug-2019.Expiration date: 2024-08-25.No anomalies found related to the problem.To date, (b)(4) items of the same lot have been already sold without any other similar reported event.
Event or Problem Description
At 1 month after the last surgery, the patient came in reporting pain due to a quad tendon rupture and the cause of the quad tendon rupture is unknown.The surgeon performed a quad tendon repair and revised the liner.The surgery was completed successfully.The previous revision surgery was performed on (b)(6) 2021 due to a fall and patella bone rupture.The surgeon performed a patellectomy and retinaculum repair and revised the liner.

• Brand Name: GMK-REVISION FIXED TIBIAL INSERT SC SIZE 3/26MM
• Common Device Name: KNEE TIBIAL INSERT
• 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: 12859348
• Report Number: 3005180920-2021-00945
• Device Sequence Number: 4093579
• Product Code: JWH
• UDI-Device Identifier: 07630030817564
• UDI-Public: 07630030817564
• Combination Product (Y/N): N
• Initial Reporter State: IL
• 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: Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 11/23/2021

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: 08/25/2024
• Device Model Number: 02.07.0326SCF
• Device Catalogue Number: 02.07.0326SCF
• Device Lot Number: 1904799
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/05/2021
• Initial Report FDA Received Date: 11/23/2021
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 07/05/2019
• 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: Female