MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA GMK-HINGE TIBIAL INSERT

Catalog Number 02.09.0520H

Device Problem Fracture (1260)

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

Event Date 10/11/2018

Event Type  Injury  

Event Description

Post-op x-rays revealed that a screw from a hinge construct had fractured within the patient.The surgeon has not scheduled a revision at this time.Patient and primary information are pending.More information will follow the case.

Manufacturer Narrative

Update november 08, 2018.Torque driver was used to implant the inlay fixation screw.

Manufacturer Narrative

Batch review performed on 7 january 2019: lot 143032: (b)(4) items manufactured and released on 11 july 2014.Expiration date: 2019-05-31.No anomalies found related to the problem.To date, (b)(4) items of the same lot have been sold without any similar reported event.Clinical evaluation performed by medical affairs director: intraoperative fracture of the insert fixation screw in a constrained tka.To our knowledge, it is extremely unlikely that the screw can break when pure torsion is applied through the 2.5 mm hexagonal socket.The torque is anyway limited by the dedicated driver.We can therefore hypothesize that a bending moment was also applied to the screw, but the mechanics of such situation is unclear.The screw fragment was not returned to the manufacturer so we could not analyze it for potential manufacturing defects.

• Brand Name: GMK-HINGE TIBIAL INSERT
• Type of Device: TIBIAL INSERT
• Manufacturer (Section D): MEDACTA INTERNATIONAL SA; strada regina; castel san pietro, switzerland 6874 ; SZ 6874
• MDR Report Key: 8054902
• MDR Text Key: 128324133
• Report Number: 3005180920-2018-00877
• Device Sequence Number: 1
• Product Code: KRO
• Combination Product (y/n): N
• PMA/PMN Number: K130299
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Type of Report: Initial,Followup,Followup
• Report Date: 01/25/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/09/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 05/31/2019
• Device Catalogue Number: 02.09.0520H
• Device Lot Number: 143032
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 10/11/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other; Required Intervention