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

Catalog Number	02.07.0412PSF
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	05/18/2018
Type of Reportable Event	Serious Injury
Additional 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 or Problem 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
• Common Device Name: TIBIAL INSERT PS FIXED
• Manufacturer (Section D): MEDACTA INTERNATIONAL SA; strada regina; castel san pietro, switzerland 6874 ; SZ 6874
• MDR Report Key: 7544738
• Report Number: 3005180920-2018-00376
• Device Sequence Number: 1862850
• Product Code: JWH
• UDI-Device Identifier: 07630030817748
• UDI-Public: 07630030817748
• Combination Product (Y/N): N
• Initial Reporter Country: AU
• PMA/510(K) Number: K090988
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2016
• Device Explanted Year: 2018
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 05/25/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Expiration Date: 04/30/2020
• Device Catalogue Number: 02.07.0412PSF
• Device Lot Number: 148602
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/27/2018
• Initial Report FDA Received Date: 05/25/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 76 YR