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

Model Number	15-2964/03
Medical Device Problem Code	Loosening of Implant Not Related to Bone-Ingrowth (4002)
Health Effect - Clinical Code	Implant Pain (4561)
Type of Reportable Event	Serious Injury
Event or Problem Description
Patient has a history of fibrosis associated with nickel allergy and pain in his right knee.On (b)(6) 2023 the patient underwent revision surgery during which this porex-coated knee system was implanted with uhmwpe distal femoral and proximal tibial augments.Imaging reveals fractured distal femur cement mantle exposing the augments.Revision surgery is planned pending availability of parts to be provided under compassionate use ((b)(4)).

• 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: 19777452
• Report Number: 3006721341-2024-00016
• Device Sequence Number: 20848163
• Product Code: KRO
• UDI-Device Identifier: 04026575205882
• UDI-Public: 04026575205882
• Combination Product (Y/N): N
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted 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): 07/18/2024
• Report Date (Section F): 06/28/2024

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: 15-2964/03
• Device Catalogue Number: 15-2964/03
• Device Lot Number: 2146036
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 06/19/2024
• Device Age: 3 YR
• Event Location: Hospital
• Date Report to Manufacturer: 06/28/2024
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 07/18/2024
• 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: 75 YR
• Patient Sex: Male
• Patient Weight: 82 KG