MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA GMK-SPHERE 02.07.1206R TIBIAL TRAY FIXED CEMENTED SIZE 6 R; KNEE TIBIAL TRAY FIXED CEMENTED

Model Number	02.07.1206R
Health Effect - Clinical Code	Pain (1994)
Date of Event	05/16/2022
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Batch review performed on 24-may-2022.Lot 2009500: 33 items manufactured and released on 20-jan-2021.Expiration date: 2026-jan-10.No anomalies found related to the problem.To date, 19 items of the same lot have been sold with no similar reported event.
Event or Problem Description
At about 9 months after the primary surgery, the patient came in reporting pain due to a loose tibial tray and the cause is unknown.The surgeon revised the tibial tray and insert.The surgery was completed successfully.

• Brand Name: GMK-SPHERE 02.07.1206R TIBIAL TRAY FIXED CEMENTED SIZE 6 R
• Common Device Name: KNEE TIBIAL TRAY FIXED CEMENTED
• 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: 14698599
• Report Number: 3005180920-2022-00448
• Device Sequence Number: 12055747
• Product Code: JWH
• UDI-Device Identifier: 07630030819957
• UDI-Public: 07630030819957
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K090988
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2021
• Device Explanted Year: 2022
• 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): 06/15/2022

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: 01/10/2026
• Device Model Number: 02.07.1206R
• Device Catalogue Number: 02.07.1206R
• Device Lot Number: 2009500
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/16/2022
• Initial Report FDA Received Date: 06/15/2022
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 01/20/2021
• 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: Male