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

Catalog Number 02.07.0412PSF

Device Problems Detachment Of Device Component (1104); Loose or Intermittent Connection (1371); Device Operates Differently Than Expected (2913)

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

Event Date 05/18/2018

Event Type  Injury  

Manufacturer Narrative

Batch review performed on 25 may 2018: lot 148602: (b)(4) items manufactured and released on 19 june 2015.Expiration date: 2020-04-30.No anomalies found related to the issue.To date, (b)(4) items of the same lot have been already sold without any similar reported event.Other implant involved: gmk-primary tibial tray fixed cemented size 4 r reference 02.07.1204r (k090988); lot 161489: (b)(4) items manufactured and released on 29 april 2016.Expiration date: 2021-04-10.No anomalies found related to the issue.To date, all the items of the same lot have been already sold without any similar reported event.Clinical evaluation performed by medical affairs manager on 25 may 2018 insert fixation screw was found loose after a traumatic event occurred 1 year and 7 months after implantation of a postero stabilized knee system.Screw removal and replacement is strongly recommended.The traumatic accident is likely to be the cause of this event but this cannot be confirmed on the basis of available information.

Event Description

On (b)(6) 2018 we were informed about a loose inlay-fixation screw of a primary-ps knee; the patient had a traumatic event.It is not know if the screw was loose before the traumatic event.Revision surgery performed on (b)(6) 2018 during surgery they recognized that the knee was very unstable and the lateral collateral ligament was completely missing; it is unknown if it was missing before or if it was related to the trauma.Also the tibia plateau was sunken.They finally implanted a gmk-hinge.

• Brand Name: GMK-PRIMARY TIBIAL INSERT PS FIXED SIZE 4/12MM
• Type of Device: TIBIAL INSERT PS FIXED
• Manufacturer (Section D): MEDACTA INTERNATIONAL SA; strada regina; castel san pietro, switzerland 6874 ; SZ 6874
• Manufacturer (Section G): MEDACTA INTERNATIONAL SA; strada regina; castel san pietro, switzerland 6874 ; SZ 6874
• Manufacturer Contact: stefano baj ; strada regina; castel san pietro, switzerland 6874 ; SZ 6874
• MDR Report Key: 7544738
• MDR Text Key: 109270425
• Report Number: 3005180920-2018-00376
• Device Sequence Number: 1
• Product Code: JWH
• UDI-Device Identifier: 07630030817748
• UDI-Public: 07630030817748
• Combination Product (y/n): N
• Reporter Country Code: AU
• PMA/PMN Number: K090988
• 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: 05/25/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/25/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 04/30/2020
• Device Catalogue Number: 02.07.0412PSF
• Device Lot Number: 148602
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 04/27/2018
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 06/19/2015
• 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: 76 YR