MAUDE Adverse Event Report: WALDEMAR LINK GMBH & CO. KG ENDO-MODEL STANDARD KNEE PROSTHESIS SYSTEM; ENDO-MODEL PROXIMAL TIBIAL SPACERS UHMWPE

Model Number	15-2516/29
Medical Device Problem Code	Device Appears to Trigger Rejection (1524)
Health Effect - Clinical Code	Implant Pain (4561)
Date of Event	06/10/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
During a telephone visit with the patient on (b)(6) 2025, the surgeon recommended the patient undergo revision tka for knee pain.During a prior visit on (b)(6) 2025, the x-rays showed well-fixed tibial and femoral components, but the physician believes a polyethylene augment (implanted (b)(6) 2022) may be causing pain.

• Brand Name: ENDO-MODEL STANDARD KNEE PROSTHESIS SYSTEM
• Common Device Name: ENDO-MODEL PROXIMAL TIBIAL SPACERS UHMWPE
• Manufacturer (Section D): WALDEMAR LINK GMBH & CO. KG; barkhausenweg 10; hamburg, 22339 ; GM 22339
• MDR Report Key: 22904776
• Report Number: 3006721341-2025-00015
• Device Sequence Number: 8001096
• Product Code: KRO
• UDI-Device Identifier: 04026575204212
• UDI-Public: 04026575204212
• Combination Product (Y/N): N
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2022
• 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): 08/27/2025
• Report Date (Section F): 08/11/2025

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
• Device Expiration Date: 09/30/2026
• Device Model Number: 15-2516/29
• Device Catalogue Number: 15-2516/29
• Device Lot Number: 2140039
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 08/08/2025
• Device Age: 4 YR
• Event Location: Hospital
• Date Report to Manufacturer: 08/11/2025
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 08/27/2025
• 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: 74 YR
• Patient Sex: Female