MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA GMK-PRIMARY TIBIAL TRAY FIXED CEMENTED SIZE 3 L; CEMENTED TIBIAL TRAY

Model Number	02.07.1203L
Medical Device Problem Code	Migration (4003)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	03/11/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
At 9 years and 4 months after primary, the surgeon revised the tibial tray fixed cemented for implant subsidence.The reason of subsidence is unknown.
Additional Manufacturer Narrative
Batch review performed on 15 march 2022: lot 122831: 50 items manufactured and released on 10-oct-2012.Expiration date: 2017-09-30.No anomalies found related to the problem.To date, 49 items of the same lot have been sold without any similar reported event since 1-1-2018.

• Brand Name: GMK-PRIMARY TIBIAL TRAY FIXED CEMENTED SIZE 3 L
• Common Device Name: CEMENTED TIBIAL TRAY
• 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, switzerland 6874 ; SZ 6874
• MDR Report Key: 14011545
• Report Number: 3005180920-2022-00247
• Device Sequence Number: 5622313
• Product Code: JWH
• UDI-Device Identifier: 07630030819889
• UDI-Public: 07630030819889
• Combination Product (Y/N): N
• Initial Reporter State: IL
• Initial Reporter Country: US
• PMA/510(K) Number: K090988
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2012
• Device Explanted Year: 2022
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 04/05/2022

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: 09/30/2017
• Device Model Number: 02.07.1203L
• Device Catalogue Number: 02.07.1203L
• Device Lot Number: 122831
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/11/2022
• Initial Report FDA Received Date: 04/05/2022
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 10/10/2012
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Female