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

Model Number	15-2964/02
Medical Device Problem Code	Loosening of Implant Not Related to Bone-Ingrowth (4002)
Health Effect - Clinical Code	Joint Laxity (4526)
Date of Event	06/06/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
This patient had these devices implanted during a revision surgery on (b)(6) 2023.[the previous femoral components were a commercially available porex femur and stem and custom-coated porex femoral augments (comp-051) implanted (b)(6) 2022 and the revision of these components on (b)(6) 2022 has been previously reported in linkbio complaint (b)(4).The patient's follow-up visit notes were sent to linkbio on (b)(6) 2023.The most recent follow-up visit note dated (b)(6) 2023 indicates that the patient has distal femur pain with radiographic studies showing loosening of the femoral cement mantle and stem, which dr.M thinks may be resulting from the polyethylene augment that she has on the femoral side.Dr.Maale sees no problems on the tibial side.Dr.M plans to revise the femoral side with a custom design.

• 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: 17390907
• Report Number: 3006721341-2023-00015
• Device Sequence Number: 6844970
• Product Code: JDI
• UDI-Device Identifier: 04026575205875
• UDI-Public: (01)04026575205875(17)260731(10)2131015
• 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): 07/25/2023
• Report Date (Section F): 06/29/2023

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?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 07/31/2026
• Device Model Number: 15-2964/02
• Device Catalogue Number: 15-2964/02
• Device Lot Number: 2131015
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 06/28/2023
• Event Location: Hospital
• Date Report to Manufacturer: 06/29/2023
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 07/25/2023
• 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: 64 YR
• Patient Sex: Female
• Patient Weight: 69 KG