MAUDE Adverse Event Report: WALDEMAR LINK GMBH & CO. KG TRABECULINK FEMORAL CONES

Model Number	15-3992/07
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	Medical device site infection (4845)
Type of Reportable Event	Serious Injury
Event or Problem Description
Unknown event date: informed on (b)(6) 2024 due to further surgical intervention following an accident, that a patient had an infection after surgery in 2022.Patient originally had a revision knee done (b)(6) 2022) and a medacta sensitin hinge was implanted with a link femoral proximal cone and a link tibia half cone.Patient was infected and reported to have an i&d on (b)(6) 2022.Patient had an accident some time in 2024 and the implants were removed on (b)(6) 2024.

• Brand Name: TRABECULINK FEMORAL CONES
• Common Device Name: TRABECULINK FEMORAL CONES
• Manufacturer (Section D): WALDEMAR LINK GMBH & CO. KG; barkhausenweg 10; hamburg, 22339 ; GM 22339
• MDR Report Key: 20067694
• Report Number: 3006721341-2024-00018
• Device Sequence Number: 8440495
• Product Code: MBH
• UDI-Device Identifier: 04026575182435
• UDI-Public: 04026575182435
• Combination Product (Y/N): N
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2022
• Device Explanted Year: 2024
• Serviced by Third Party (Y/N): N
• Reporter Type: Importer
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 08/26/2024
• Report Date (Section F): 07/31/2024

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?: Yes
• Operator of Device: Health Professional
• Device Model Number: 15-3992/07
• Device Catalogue Number: 15-3992/07
• Device Lot Number: 2135149
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 07/30/2024
• Device Age: 4 YR
• Event Location: Hospital
• Date Report to Manufacturer: 07/31/2024
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 08/26/2024
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 80 YR
• Patient Sex: Male