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

Model Number	880-071/50
Medical Device Problem Codes	Patient-Device Incompatibility (2682); Loosening of Implant Not Related to Bone-Ingrowth (4002)
Health Effect - Clinical Code	Joint Laxity (4526)
Date of Event	05/08/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
Linkbio reviewed a patient record which described revision of this link knee (implanted (b)(6) 2023) on (b)(6) 2023.The office visit note preceding the revision surgery (dated (b)(6) 2023) indicates possible periprothetic left knee infection associated with cellulitis.Communication from surgeon indicates no known infection present for this revision.Dr.Was unsure of the cause for arthrofibrosis but patient presented with multi-directional instability.Patient's ltt testing reflects mildly reactive to aluminum and vanadium.

• Brand Name: LINKSYMPHOKNEE
• Common Device Name: LINKSYMPHOKNEE
• Manufacturer (Section D): WALDEMAR LINK GMBH & CO. KG; barkhausenweg 10; hamburg, 22339 ; GM 22339
• MDR Report Key: 22480033
• Report Number: 3006721341-2025-00012
• Device Sequence Number: 18309969
• Product Code: KRO
• UDI-Device Identifier: 04026575249794
• UDI-Public: (01)04026575249794(17)270228
• Combination Product (Y/N): N
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2023
• Device Explanted 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): 07/11/2025
• Report Date (Section F): 06/30/2025

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: 880-071/50
• Device Catalogue Number: 880-071/50
• Device Lot Number: 200824
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 06/26/2025
• Device Age: 4 MO
• Event Location: Hospital
• Date Report to Manufacturer: 06/30/2025
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 07/11/2025
• 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: 71 YR
• Patient Sex: Female
• Patient Weight: 84 KG