MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA GMK-HINGE FIXED TIBIAL INSERT SIZE 4/17MM

Model Number 02.09.0417H

Device Problem Material Rupture (1546)

Patient Problem Damage to Ligament(s) (1952)

Event Date 07/09/2021

Event Type  Injury  

Manufacturer Narrative

Batch review performed on 20 july 2021: lot 189417: (b)(4) items manufactured and released on 12-feb-2019. Expiration date: 2024-01-27. No anomalies found related to the problem. To date, (b)(4) items of the same lot have been sold without any similar reported event.

Event Description

The patient had a primary and was implanted with competitor implants. On (b)(6) 2019, the patient came in and had the competitor components revised to medacta for reasons unknown. The surgery was completed successfully. On (b)(6) 2021, 1 year and 11 months after hinge implantation the patient came in reporting pain due to a ruptured quad tendon. The cause of the ruptured quad tendon is unknown. The surgeon performed a quad tendon repair and revised the poly. The surgery was completed successfully.

• Brand Name: GMK-HINGE FIXED TIBIAL INSERT SIZE 4/17MM
• Type of Device: 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: 12217045
• MDR Text Key: 263123935
• Report Number: 3005180920-2021-00632
• Device Sequence Number: 1
• Product Code: KRO
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K130299
• 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: 07/23/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/23/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No

Device Operator

• Device Model Number: 02.09.0417H
• Device Catalogue Number: 02.09.0417H
• Device Lot Number: 189417
• Was Device Available for Evaluation?: No

Is the Reporter a Health Professional?

Was the Report Sent to FDA?

• Event Location: No Information
• Date Manufacturer Received: 08/08/2021
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 02/12/2019
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial

Patient Treatment Data

Date Received: 07/23/2021 Patient Sequence Number: 1