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

Model Number	15-0027/14
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	Medical device site infection (4845)
Date of Event	02/03/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
Patient has had multiple revisions.The subject devices were implanted during revision knee arthroplasty on (b)(6) 2024.Subsequently, on (b)(6) 2024 the patient presented to the emergency dept.With infected knee wound dehiscence and was taken to surgery for irrigation and debridement during which the femoral component and tibial plateau were replaced as part of the washout.No information alleges implant performance issues or observed implant damage.

• Brand Name: ENDO-MODEL STANDARD KNEE PROSTHESIS SYSTEM
• Common Device Name: ENDO-MODEL STANDARD KNEE PROSTHESIS SYSTEM
• Manufacturer (Section D): WALDEMAR LINK GMBH & CO. KG; barkhausenweg 10; hamburg, 22339 ; GM 22339
• MDR Report Key: 19173638
• Report Number: 3006721341-2024-00008
• Device Sequence Number: 18097226
• Product Code: KRO
• UDI-Device Identifier: 04026575432110
• UDI-Public: (01)04026575432110(17)280930(10)2341266
• Combination Product (Y/N): N
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2024
• 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): 04/24/2024
• Report Date (Section F): 04/17/2024

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: 15-0027/14
• Device Catalogue Number: 15-0027/14
• Device Lot Number: 2341266
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 04/16/2024
• Event Location: Hospital
• Date Report to Manufacturer: 04/17/2024
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 04/24/2024
• 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: 70 YR
• Patient Sex: Male
• Patient Weight: 65 KG