MAUDE Adverse Event Report: WALDEMAR LINK GMBH & CO. KG ENDO EVO W MODULAR JOINT COMPONENT; LINK ENDO-MODEL EVO KNEE SYSTEM

Model Number	15-8541/10
Medical Device Problem Code	Improper or Incorrect Procedure or Method (2017)
Health Effect - Clinical Code	Joint Laxity (4526)
Type of Reportable Event	Serious Injury
Event or Problem Description
Notifed by representative (b)(6) that a surgery was performed on (b)(6) 2025 using an endo evo w with an optistem adaptor, and it became disassociated a few weeks later and had to be revised.The representative stated that when the revision of the components took place, they noticed that the set screw was not used in the femoral component and optistem adaptor junction.A revision occurred on (b)(6) 2025 without any issues when the set screw was used.

• Brand Name: ENDO EVO W MODULAR JOINT COMPONENT
• Common Device Name: LINK ENDO-MODEL EVO KNEE SYSTEM
• Manufacturer (Section D): WALDEMAR LINK GMBH & CO. KG; barkhausenweg 10; hamburg, 22339 ; GM 22339
• MDR Report Key: 24250411
• Report Number: 3006721341-2026-00001
• Device Sequence Number: 8233711
• Product Code: KRO
• UDI-Device Identifier: 04026575223657
• UDI-Public: 04026575223657
• Combination Product (Y/N): N
• Initial Reporter State: IN
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2025
• Device Explanted Year: 2025
• 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): 02/03/2026
• Report Date (Section F): 01/14/2026

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?: Yes
• Device Model Number: 15-8541/10
• Device Catalogue Number: 15-8541/10
• Device Lot Number: 240722
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 01/13/2026
• Device Age: 7 MO
• Event Location: Hospital
• Date Report to Manufacturer: 01/14/2026
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 02/03/2026
• 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: 48 YR
• Patient Sex: Male