MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA GMK-REVISION 02.07.0684L REVISION FIXED TIBIAL TRAY CEMENTED SIZE 4 L; KNEE REVISION FIXED TIBIAL TRAY CEMENTED

Model Number	02.07.0684L
Medical Device Problem Code	Loosening of Implant Not Related to Bone-Ingrowth (4002)
Health Effect - Clinical Code	Implant Pain (4561)
Date of Event	02/20/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Batch review performed on 21-feb-2023.Lot: 1905611: (b)(4) items manufactured and released on 18-dec-2019.Expiration date: 2024-12-07.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 2 years and 9 months after the previous revision surgeries, the patient came in reporting pain due to a loose tibia and the cause is unknown.The surgeon revised successfully the tibia and insert.This is the 4th revision surgery for this patient.The first one was performed due to laxity caused by a fall and the insert was revised.The second revision surgery was performed due to instability (revised the insert and tibial tray).The third revision surgery was performed due to a loose tibial tray caused by a trauma (revision of insert and tibial tray).

• Brand Name: GMK-REVISION 02.07.0684L REVISION FIXED TIBIAL TRAY CEMENTED SIZE 4 L
• Common Device Name: KNEE REVISION FIXED TIBIAL TRAY CEMENTED
• 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, switzerland 6874 ; SZ 6874
• MDR Report Key: 16589561
• Report Number: 3005180920-2023-00158
• Device Sequence Number: 5088761
• Product Code: JWH
• UDI-Device Identifier: 07630030819384
• UDI-Public: 07630030819384
• 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: 2020
• 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): 03/22/2023

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: 12/07/2024
• Device Model Number: 02.07.0684L
• Device Catalogue Number: 02.07.0684L
• Device Lot Number: 1905611
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/20/2023
• Initial Report FDA Received Date: 03/22/2023
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 12/18/2019
• 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 Age: 62 YR
• Patient Sex: Male
• Patient Weight: 102 KG