MAUDE Adverse Event Report: WALDEMAR LINK GMBH & CO. KG ENDO-MODEL MODULAR KNEE PROSTHESIS SYSTEM; ENDO MODEL MODULAR FEMUR AND TIBIA, POREX, LARGE, RIGHT

Model Number	15-3818/11
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	04/12/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
It was confirmed on (b)(6) 2024, that an incorrect side knee was ordered by the sales rep (right instead of left) for an (b)(6) 2023 surgery.(2 right-side parts were ordered and sent as ordered).It was only realized during the surgery, after the procedure had been started, that the incorrect implants had been ordered, and the procedure could not continue.Subsequent to this incomplete surgery, the correct parts were then ordered by the sales rep and the new order was sent.The patient had to return for the second surgery, where the correct left-side device was implanted on (b)(6) 2023.

• Brand Name: ENDO-MODEL MODULAR KNEE PROSTHESIS SYSTEM
• Common Device Name: ENDO MODEL MODULAR FEMUR AND TIBIA, POREX, LARGE, RIGHT
• Manufacturer (Section D): WALDEMAR LINK GMBH & CO. KG; barkhausenweg 10; hamburg, 22339 ; GM 22339
• MDR Report Key: 20181769
• Report Number: 3006721341-2024-00023
• Device Sequence Number: 8196693
• Product Code: KRO
• UDI-Device Identifier: 04026575164028
• UDI-Public: 04026575164028
• Combination Product (Y/N): N
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• 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): 08/22/2024

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?: No
• Operator of Device: Health Professional
• Device Model Number: 15-3818/11
• Device Catalogue Number: 15-3818/11
• Device Lot Number: 210112
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 08/21/2024
• Device Age: 1 YR
• Event Location: Hospital
• Date Report to Manufacturer: 08/22/2024
• 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: 62 YR
• Patient Sex: Male