MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA GMK-HINGE TIBIAL INSERT SIZE 1/17MM

Catalog Number 02.09.0117H

Device Problem Device Issue (2379)

Patient Problem Failure of Implant (1924)

Event Date 10/12/2017

Event Type  malfunction  

Manufacturer Narrative

This is the second revision surgery underwent by the patient.The patient had a primary knee on (b)(6) 2014.During the primary the torque driver was used.The patient came in due to signs of infection.The patient tested positive for granulicatella adiacens.On (b)(6) 2016 the surgeon removed all implants.On (b)(6) 2016 the surgeon re-implanted medacta components.In (b)(6) 2017 the surgeon determined that the screw and hinge mechanism dissociated from the morse taper of the yoke.The surgeon planned to perform a poly swap on (b)(6) 2017.Batch review performed on 09 november 2017.Lot 140422: (b)(4) items manufactured and released on 19 february 2014.Expiration date: 2019-01-31.No anomalies found related to the problem.To date, (b)(4) items of the same lot have been already sold without any similar reported event.

Event Description

The patient originally came in due to a clicking noise in her knee.The surgeon determined the screw had backed out of the yoke.The surgeon performed a poly swap.There was no damage to the screw or the yoke.The surgeon threaded the screw back into the yoke.It went in with no issue.The surgery was completed successfully.

• Brand Name: GMK-HINGE TIBIAL INSERT SIZE 1/17MM
• 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, 6874 ; SZ 6874
• MDR Report Key: 7018030
• MDR Text Key: 92979601
• Report Number: 3005180920-2017-00652
• Device Sequence Number: 1
• Product Code: KRO
• UDI-Device Identifier: 07630030825002
• UDI-Public: 07630030825002
• 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: Other
• Type of Report: Initial
• Report Date: 11/10/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/10/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 01/31/2019
• Device Catalogue Number: 02.09.0117H
• Device Lot Number: 140422
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 10/12/2017
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 02/19/2014
• 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 Age: 68 YR