MAUDE Adverse Event Report: WALDEMAR LINK GMBH & CO. KG LINKSYMPHOKNEE SYSTEM; ARTICULATING SURFACE, SYMMETRIC, SZ. 3-4 X-LINKED VIT-E PE, CR, FIXED, H= 12 MM

Model Number	880-243/12
Medical Device Problem Code	Naturally Worn (2988)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	04/21/2026
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The review of the device history record showed no deviations.The product complies with the specifications valid at the time of manufacture.
Event or Problem Description
Notified on 4/28/2026 regarding a revision to an lsk tibial plateau with dr.(b)(6) that occurred on (b)(6) 2026.The original surgery was performed on (b)(6) 2023.Explanted plateau will not be returned.[customer].

• Brand Name: LINKSYMPHOKNEE SYSTEM
• Common Device Name: ARTICULATING SURFACE, SYMMETRIC, SZ. 3-4 X-LINKED VIT-E PE, CR, FIXED, H= 12 MM
• Manufacturer (Section D): WALDEMAR LINK GMBH & CO. KG; barkhausenweg 10; hamburg, 22339 ; GM 22339
• Manufacturer Contact: lisa effe ; barkhausenweg 10; hamburg, 22339 ; GM 22339
• MDR Report Key: 25215430
• Report Number: 3004371426-2026-00033
• Device Sequence Number: 9810932
• Product Code: HRY
• UDI-Device Identifier: 04026575255382
• UDI-Public: 04026575255382
• Combination Product (Y/N): N
• Initial Reporter State: NJ
• Initial Reporter Country: US
• PMA/510(K) Number: K202924
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2023
• Device Explanted Year: 2026
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Distributor
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 04/21/2026

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: 880-243/12
• Device Catalogue Number: 880-243/12
• Device Lot Number: 2134138
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/21/2026
• Initial Report FDA Received Date: 05/19/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 11/01/2021
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Female