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

Model Number	02.07.0683L
Medical Device Problem Code	Loosening of Implant Not Related to Bone-Ingrowth (4002)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	02/24/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Batch review performed on 28-feb-2023: lot 162502: (b)(4) items manufactured and released on 25-may-2016.Expiration date: 2021-05-12.No anomalies found related to the problem.To date, (b)(4) items of the same lot have been sold with no similar reported case during the period of review.
Event or Problem Description
At about 5 years and 5 months after the system has been implanted, the patient came in reporting pain due to tibial tray loosening and the cause is unknown.The surgeon revised successfully the tibial tray and insert.The patient was previously revised from competitor to medacta implants.

• Brand Name: GMK-REVISION REVISION FIXED TIBIAL TRAY CEMENTED SIZE 3 L
• Common Device Name: FIXED TIBIAL TRAY
• Manufacturer (Section D): MEDACTA INTERNATIONAL SA; strada regina; castel san pietro, switzerland 6874 ; SZ 6874
• Manufacturer (Section G): MEDACTA INTERNATIONAL SA; strada regina; castel san pietro, switzerland 6874 ; SZ 6874
• Manufacturer Contact: marco giannessi ; strada regina; castel san pietro, 6874 ; SZ 6874
• MDR Report Key: 16583851
• Report Number: 3005180920-2023-00166
• Device Sequence Number: 4697374
• Product Code: JWH
• UDI-Device Identifier: 07630030819360
• UDI-Public: 07630030819360
• 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: 2017
• Device Explanted Year: 2023
• 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): 03/21/2023

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: 05/12/2021
• Device Model Number: 02.07.0683L
• Device Catalogue Number: 02.07.0683L
• Device Lot Number: 162502
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/24/2023
• Initial Report FDA Received Date: 03/21/2023
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 05/25/2015
• 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: Unknown