MAUDE Adverse Event Report: WALDEMAR LINK GMBH & CO. KG ENDO-MODEL MODULAR KNEE PROSTHESIS SYSTEM

Model Number	15-3817/12
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
Notified by dr.M on aug.6, 2024 that a patient became infected and the implants had to be removed and were replaced by a fusion nail device.Originally implanted on (b)(6) 2022.Fusion nail procedure completed on (b)(6) 2023.

• Brand Name: ENDO-MODEL MODULAR KNEE PROSTHESIS SYSTEM
• Common Device Name: ENDO-MODEL MODULAR KNEE PROSTHESIS SYSTEM
• Manufacturer (Section D): WALDEMAR LINK GMBH & CO. KG; barkhausenweg 10; hamburg, 22339 ; GM 22339
• MDR Report Key: 20070484
• Report Number: 3006721341-2024-00019
• Device Sequence Number: 7783829
• Product Code: KRO
• UDI-Device Identifier: 04026575164059
• UDI-Public: 04026575164059
• Combination Product (Y/N): N
• Initial Reporter State: NJ
• Initial Reporter Country: US
• 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: Importer
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 08/26/2024
• Report Date (Section F): 08/07/2024

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 Expiration Date: 07/31/2025
• Device Model Number: 15-3817/12
• Device Catalogue Number: 15-3817/12
• Device Lot Number: 190924
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 08/06/2024
• Device Age: 3 YR
• Event Location: Hospital
• Date Report to Manufacturer: 08/07/2024
• 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: 67 YR
• Patient Sex: Male