MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA GMK-REVISION FIXED TIBIAL INSERT SC SIZE 2/20MM; KNEE TIBIAL INSERT

Model Number	02.07.0220SCF
Health Effect - Clinical Code	Joint Laxity (4526)
Date of Event	09/18/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Batch review performed on 29 september 2020: lot 170558: (b)(4) items manufactured and released on 07-mar-2017.Expiration date: 2022-02-15.No anomalies found related to the problem.To date, 4 items of the same lot have been already sold without any similar reported event.Additional devices involved: batch reviews performed on 29 september 2020: gmk-revision 02.07.0036rp patella resurfacing size 4 (k113571) lot 1907569: (b)(4) items manufactured and released on 01-oct-2019.Expiration date: 2024-09-16.No anomalies found related to the problem.To date, 171 items of the same lot have been already sold without any similar reported event.Gmk-revision 02.07.F11030 primary extension stem ø11mm / l 30 mm (k133630) lot.1907884: (b)(4) items manufactured and released on 19-nov-2019.Expiration date: 2024-11-09.No anomalies found related to the problem.To date, 143 items of the same lot have been already sold without any similar reported event.Gmk-revision 02.07.2403r femur revision ps size 3 r (k102437) lot 1905605: (b)(4) items manufactured and released on 29-oct-2019.Expiration date: 2024-10-19.No anomalies found related to the problem.To date, 17 items of the same lot have been already sold without any similar reported event.Gmk-revision 02.07.0682r revision fixed tibial tray cemented size 2 (k123721) lot 1903716: (b)(4) items manufactured and released on 25-sep-2019.Expiration date: 2024-09-18.No anomalies found related to the problem.To date, 9 items of the same lot have been already sold without any similar reported event.Gmk-revision 02.07.Fsc13065 extension stem - cemented ø 13 l 65 (k120790) lot 1903733: (b)(4) items manufactured and released on 10-sep-2019.Expiration date: 2024-09-09.No anomalies found related to the problem.To date, 33 items of the same lot have been already sold without any similar reported event.
Event or Problem Description
The patient had a primary surgery and was implanted with competitor products.On (b)(6) 2020, the patient had the competitor products revised to medatca products.The reason for the revision was unknown.Presently, on (b)(6) 2020, 7 months after previous surgery, the patient came in reporting instability and the cause of the instability is unknown.The surgeon revised all gmk-revision components to gmk-hinge components.The surgery was completed successfully.

• Brand Name: GMK-REVISION FIXED TIBIAL INSERT SC SIZE 2/20MM
• Common Device Name: KNEE TIBIAL INSERT
• Manufacturer (Section D): MEDACTA INTERNATIONAL SA; strada regina; castel san pietro, 6874 ; SZ 6874
• MDR Report Key: 10669527
• Report Number: 3005180920-2020-00716
• Device Sequence Number: 11445176
• Product Code: JWH
• UDI-Device Identifier: 07630030816932
• UDI-Public: 07630030816932
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K103170
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2020
• Device Explanted Year: 2020
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: other
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 10/13/2020

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: 02/15/2022
• Device Model Number: 02.07.0220SCF
• Device Catalogue Number: 02.07.0220SCF
• Device Lot Number: 170558
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/18/2020
• Initial Report FDA Received Date: 10/13/2020
• 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