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

Model Number 02.07.0326SCF

Device Problem Material Rupture (1546)

Patient Problem Muscle/Tendon Damage (4532)

Event Date 11/05/2021

Event Type  Injury  

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 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
• Type of Device: 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
• MDR Text Key: 281136249
• Report Number: 3005180920-2021-00945
• Device Sequence Number: 1
• Product Code: JWH
• UDI-Device Identifier: 07630030817564
• UDI-Public: 07630030817564
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K103170
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Company Representative
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 11/23/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/23/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 02.07.0326SCF
• Device Catalogue Number: 02.07.0326SCF
• Device Lot Number: 1904799
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 11/05/2021
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 07/05/2019
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Sex: Female