MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA GMK-HINGE FIXED TIBIAL INSERT SIZE 4/12MM KNEE TIBIAL INSERT

Model Number 02.09.0412H

Device Problem Material Integrity Problem (2978)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 11/04/2019

Event Type  Injury  

Manufacturer Narrative

Batch review performed on 19-november-2019: lot 143022: (b)(4) items manufactured and released on 29-july-2014. Expiration date: 30. 06. 2019. No anomalies found related to the problem. To date, 22 items of the same lot have been already sold without any other similar reported event. Clinical evaluation performed by medacta medical affairs director: 2. 5 years after revision tka with a constrained device, the screw connecting the femoral component to the tibial post backs out and gets loose in the joint. In such conditions, dynamics is altered and the femur was probably giving unpredictable stresses to the inlay. The screw fixing the inlay to the tibial baseplate also broke. At revision surgery, a new inlay was placed with no screw. The root cause for this event is probably self-unscrewing of the post screw. The cause for self-unscrewing cannot be determined, one possible explanation could be insufficient tightening torque at surgery, but other conditions may also have played a role. Preliminary investigation by r&d knee manger: revision surgery performed due to unscrewing of the post screw and pivot disengagement on an hinge implant more than 2 years from the primary surgery. During the revision surgery, it was discovered that the inlay locking screw was broken. The surgeon only revised the 12 mm inlay with a 17 mm inlay, it was not possible to use a new inlay locking screw because a part of the broken screw remained in the tibial tray. Preliminary investigation based on the picture of the broken tibial insert secure screw and unscrewed hinge pivot fixation screw. Head and part of the threaded shaft of the hinge post screw look partially damaged, signed and plastically deformed. These damages occurred most likely when, loosened in the joint, the screw was interposed between two articulating parts and underwent to body loads. Tibial insert secure screw was found broken in 2 parts during revision surgery. The head of the screw was removed; the other part remained seated in the baseplate. The screw broke in correspondence of its threaded shaft, in its portion out of the baseplate. Breakage of the screw was most likely caused by unexpected loads acting on the tibial insert when the hinge post was disconnected from the femoral component. Possible reason for unscrewing of the hinge post screw can't be identified with the information available and still remain unknown.

Event Description

Revision surgery performed due to post screw unscrewing and pivot disengagement from the hinge more than 2 years from the primary surgery. During the revision surgery, it was discovered that the inlay locking screw was broken. The surgeon only revised the 12 mm inlay with a 17 mm inlay, it was not possible to use a new inlay locking screw because a part of the broken screw remained in the tibial tray.

• Brand Name: GMK-HINGE FIXED TIBIAL INSERT SIZE 4/12MM
• 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; castel san pietro, 6874 ; SZ 6874
• Manufacturer Contact: stefano baj ; strada regina; castel san pietro, switzerland 6874 -CHE ; SZ 6874 CHE
• MDR Report Key: 9410175
• MDR Text Key: 213692023
• Report Number: 3005180920-2019-01013
• Device Sequence Number: 1
• Product Code: KRO
• Combination Product (y/n): N
• Reporter Country Code: FR
• 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,Followup
• Report Date: 04/12/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/04/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes

Device Operator

• Device Expiration Date: 06/30/2019
• Device Model Number: 02.09.0412H
• Device Catalogue Number: 02.09.0412H
• Device Lot Number: 143022
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/26/2020

Is the Reporter a Health Professional?

Was the Report Sent to FDA?

• Event Location: No Information
• Date Manufacturer Received: 11/04/2019
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/29/2014
• 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: 12/04/2019 Patient Sequence Number: 1