MAUDE Adverse Event Report: WALDEMAR LINK GMBH & CO. KG LINKSYMPHOKNEE

Model Number	880-081/40
Medical Device Problem Code	Loosening of Implant Not Related to Bone-Ingrowth (4002)
Health Effect - Clinical Codes	Joint Laxity (4526); Implant Pain (4561)
Date of Event	02/04/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
In a letter dated 04-feb-2025, the surgeon stated that the patient, who is allergic to cobalt and cement, has a painful left knee with an existing revision construct (cemented femur, cementless stems), and after imaging review and patient examination, it appears the pain is associated with loosening of the current implant.Surgeon advises that there was not a large enough stem available for adequate press fit, and the inflammatory reaction the patient had from a chronic infection caused it to loosen early.Revision of the femoral component is planned.

• Brand Name: LINKSYMPHOKNEE
• Common Device Name: LINKSYMPHOKNEE
• Manufacturer (Section D): WALDEMAR LINK GMBH & CO. KG; barkhausenweg 10; hamburg, 22339 ; GM 22339
• MDR Report Key: 22440788
• Report Number: 3006721341-2025-00009
• Device Sequence Number: 4708430
• Product Code: KRO
• UDI-Device Identifier: 04026575250530
• UDI-Public: (01)04026575250530(17)280531
• 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): 07/08/2025
• 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?: No
• Operator of Device: Health Professional
• Device Model Number: 880-081/40
• Device Catalogue Number: 880-081/40
• Device Lot Number: 200330
• 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: 2 YR
• Event Location: Hospital
• Date Report to Manufacturer: 06/24/2025
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 07/08/2025
• 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: 60 YR
• Patient Sex: Unknown