MAUDE Adverse Event Report: WALDEMAR LINK GMBH & CO. KG ENDO-MODEL MODULAR KNEE PROSTHESIS SYSTEM; MEGA-C ENDO MODEL FEMORAL COMPONENT

Model Number	15-8521/08
Medical Device Problem Code	Loosening of Implant Not Related to Bone-Ingrowth (4002)
Health Effect - Clinical Code	Joint Laxity (4526)
Type of Reportable Event	Serious Injury
Event or Problem Description
Revision surgery occurred on (b)(6) 2024 for a femoral component that was originally implanted on (b)(6) 2023.The entire femoral construct was removed and replaced.It was noted that the hinge of the femoral component was loose.It was also noted that the proximal tibia was fractured and had healed.

• Brand Name: ENDO-MODEL MODULAR KNEE PROSTHESIS SYSTEM
• Common Device Name: MEGA-C ENDO MODEL FEMORAL COMPONENT
• Manufacturer (Section D): WALDEMAR LINK GMBH & CO. KG; barkhausenweg 10; hamburg, 22339 ; GM 22339
• MDR Report Key: 20537171
• Report Number: 3006721341-2024-00024
• Device Sequence Number: 6773201
• Product Code: KRO
• UDI-Device Identifier: 04026575383214
• UDI-Public: 04026575383214
• Combination Product (Y/N): N
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2023
• 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): 10/25/2024
• Report Date (Section F): 09/30/2024

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: 15-8521/08
• Device Catalogue Number: 15-8521/08
• Device Lot Number: 170717
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 09/27/2024
• Device Age: 1 YR
• Event Location: Hospital
• Date Report to Manufacturer: 09/30/2024
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 10/25/2024
• 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: 56 YR
• Patient Sex: Male
• Patient Weight: 165 KG