MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA GMK-REVISION FIXED TIBIAL TRAY CEMENTED SIZE 2 R; CEMENTED TIBIAL TRAY

Model Number	02.07.0682R
Health Effect - Clinical Code	Inadequate Osseointegration (2646)
Date of Event	03/18/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Batch review performed on 15-apr-2021_ lot 2004124: 20 items manufactured and released on 21-aug-2020.Expiration date: 2025-08-19.No anomalies found related to the problem.To date, 7 items of the same lot have been already sold without any other similar reported event.
Event or Problem Description
The patient had primary knee surgery and was implanted with competitor implants.On (b)(6) 2021, the patient had the competitor implants revised to medacta implants and the cause of the revision is unknown.Presently, on (b)(6) 2021, the patient came in reporting pain due to a failed tibial component, which subsided on one side.The cause of the failed tibial component is unknown.The surgeon revised the tibial tray and insert and added a fluted extension stem and tibial augment.The surgery was completed successfully.

• Brand Name: GMK-REVISION FIXED TIBIAL TRAY CEMENTED SIZE 2 R
• Common Device Name: CEMENTED TIBIAL TRAY
• Manufacturer (Section D): MEDACTA INTERNATIONAL SA; strada regina; castel san pietro, 6874 ; SZ 6874
• MDR Report Key: 11670271
• Report Number: 3005180920-2021-00306
• Device Sequence Number: 3160707
• Product Code: JWH
• UDI-Device Identifier: 07630030819353
• UDI-Public: 07630030819353
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K123721
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2021
• Device Explanted Year: 2021
• 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): 04/15/2021

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: 08/19/2025
• Device Model Number: 02.07.0682R
• Device Catalogue Number: 02.07.0682R
• Device Lot Number: 2004124
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/18/2021
• Initial Report FDA Received Date: 04/15/2021
• 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