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

Model Number	15-2516/29
Medical Device Problem Code	Device Appears to Trigger Rejection (1524)
Health Effect - Clinical Code	Implant Pain (4561)
Type of Reportable Event	Serious Injury
Event or Problem Description
The patient underwent knee revision surgery (b)(6) 2021 for a previously infected knee (manufacturer unknown) and nickel allergy.This tibial augment was implanted at that time with a link porex knee system.It appears that the femoral side was later revised (cause unknown) on (b)(6) 2023.Dr.Now plans to revise this patient due to right knee pain, which he suspects is related to the uhmwpe tibial augment.

• Brand Name: ENDO-MODEL STANDARD KNEE PROSTHESIS SYSTEM
• Common Device Name: ENDO-MODEL KNEE UHMWPE TIBIAL AUGMENT
• Manufacturer (Section D): WALDEMAR LINK GMBH & CO. KG; barkhausenweg 10; hamburg, 22339 ; GM 22339
• MDR Report Key: 20181768
• Report Number: 3006721341-2024-00022
• Device Sequence Number: 8196692
• 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: 2021
• 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): 09/10/2024
• Report Date (Section F): 08/15/2024

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 Expiration Date: 07/31/2025
• Device Model Number: 15-2516/29
• Device Catalogue Number: 15-2516/29
• Device Lot Number: 2028156
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 08/14/2024
• Device Age: 1 YR
• Event Location: Hospital
• Date Report to Manufacturer: 08/15/2024
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 09/10/2024
• 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: 55 YR
• Patient Sex: Female
• Patient Weight: 121 KG