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

Model Number	02.07.0682R
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Bone Fracture(s) (1870)
Date of Event	11/26/2022
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Batch review performed on (b)(6) 2022.Lot 2008681: 16 items manufactured and released on 25-nov-2020.Expiration date: 2025-11-15.No anomalies found related to the problem.To date, 12 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 months and 3 weeks after the primary surgery, the patient came in reporting pain due to a fractured tibia and the cause is unknown.The surgeon revised medacta tibial tray and insert.The surgery was completed successfully.

• Brand Name: GMK-REVISION REVISION FIXED TIBIAL TRAY CEMENTED SIZE 2 R
• Common Device Name: 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: stefano baj ; strada regina; castel san pietro, switzerland 6874 ; SZ 6874
• MDR Report Key: 15995230
• Report Number: 3005180920-2022-00938
• Device Sequence Number: 20320839
• 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: 2022
• 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): 12/16/2022

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: 11/15/2025
• Device Model Number: 02.07.0682R
• Device Catalogue Number: 02.07.0682R
• Device Lot Number: 2008681
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/26/2022
• Initial Report FDA Received Date: 12/16/2022
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 11/25/2020
• 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