MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA GMK-REVISION EXTENSION STEM - FLUTED Ø 16 L 65; KNEE REVISION SYSTEM EXTENSION STEM

Catalog Number	02.07.FCL16065
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Bone Fracture(s) (1870)
Date of Event	07/06/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
Revision surgery for peri-prosthetic tibial fracture, at tibial stem level, about 1 year and 3 months post primary.Tibial components revised successfully.
Additional Manufacturer Narrative
Batch review performed on (b)(6) 2023: lot 1904822: (b)(4) items manufactured and released on 11-nov-2019.Expiration date: 2024-11-02.No anomalies found related to the problem.To date, (b)(4) items of the same lot have been sold without any similar reported event in the period of review.

• Brand Name: GMK-REVISION EXTENSION STEM - FLUTED Ø 16 L 65
• Common Device Name: KNEE REVISION SYSTEM EXTENSION STEM
• 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: 17395198
• Report Number: 3005180920-2023-00565
• Device Sequence Number: 5921849
• Product Code: JWH
• UDI-Device Identifier: 07630030823022
• UDI-Public: 07630030823022
• Combination Product (Y/N): N
• Initial Reporter State: MO
• Initial Reporter Country: US
• PMA/510(K) Number: K120790
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2022
• Device Explanted Year: 2023
• 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): 07/26/2023

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: 11/02/2024
• Device Catalogue Number: 02.07.FCL16065
• Device Lot Number: 1904822
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/06/2023
• Initial Report FDA Received Date: 07/26/2023
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 11/11/2019
• 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 Sex: Unknown