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

Model Number	15-3817/12
Medical Device Problem Code	No Apparent Adverse Event (3189)
Health Effect - Clinical Codes	Implant Pain (4561); Medical device site infection (4845)
Date of Event	10/08/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
The patient had 2nd left knee revision on (b)(6) 2024, during which a link hinge knee was implanted.The patient experienced persistent swelling and eventually also increased pain and decreased rom.An infection workup was positive for staphylococcus epidermis.Revision surgery occurred (b)(6) 2024 and an antibiotic spacer was placed.According to the surgeon, the infection was not device related: the patient had a history of multiple surgeries in the past and very likely had a hidden infection with staph epidermis that led ultimately to the prosthetic joint infection, causing failure of the link implant.

• 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: 22458174
• Report Number: 3006721341-2025-00010
• Device Sequence Number: 15532533
• Product Code: KRO
• UDI-Device Identifier: 04026575164059
• UDI-Public: (01)04026575164059(17)271231
• 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): 07/09/2025
• Report Date (Section F): 06/24/2025

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: 15-3817/12
• Device Catalogue Number: 15-3817/12
• Device Lot Number: 200608
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 06/23/2025
• Device Age: 1 YR
• Event Location: Hospital
• Date Report to Manufacturer: 06/24/2025
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 07/09/2025
• 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: 65 YR
• Patient Sex: Male