MAUDE Adverse Event Report: WALDEMAR LINK GMBH & CO. KG ENDO-MODEL MODULAR KNEE PROSTHESIS SYSTEM

Model Number	15-3950/06
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Codes	Joint Laxity (4526); Implant Pain (4561)
Date of Event	08/14/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
The patient had a link hinge knee implanted (b)(6) 2022 and subsequently underwent revision knee surgery on (b)(6) 2023 (reported previously in complaint (b)(4)).The patient subsequently experienced pain.No cause was evident on x-rays.The patient underwent revision surgery on (b)(6) 2023.Presence of reactive tissue was noted.The cause is unknown, but according to the sales rep, the surgeon suspected potential infection or potential allergy to cement.When the doctor flexed the knee, the femur component, which had been fixed to the bone via cementing of the conical stem and 50mm uhmwpe distal femur augment, came loose from the cement.All knee components were then replaced during the surgery.The operative report for the implanting surgery on (b)(6) 2023 indicates that when preparing to implant the femoral components, the cement had been mixed one-to-one with tobramycin and upon reaching doughy consistency was hand packed around the femoral component (stem), the uhmwpe augment then placed, and the femoral assembly then inserted into the canal.

• Brand Name: ENDO-MODEL MODULAR KNEE PROSTHESIS SYSTEM
• Common Device Name: ENDO-MODEL MODULAR KNEE PROSTHESIS SYSTEM
• Manufacturer (Section D): WALDEMAR LINK GMBH & CO. KG; barkhausenweg 10; hamburg, 22339 ; GM 22339
• MDR Report Key: 17709931
• Report Number: 3006721341-2023-00022
• Device Sequence Number: 17825281
• Product Code: KRO
• UDI-Device Identifier: 04026575431687
• UDI-Public: (01)04026575431687(17)261031(10)2164333
• Combination Product (Y/N): N
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2023
• Device Explanted Year: 2023
• 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): 09/08/2023
• Report Date (Section F): 08/22/2023

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 Model Number: 15-3950/06
• Device Catalogue Number: 15-3950/06
• Device Lot Number: 2164333
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 08/21/2023
• Event Location: Hospital
• Date Report to Manufacturer: 08/22/2023
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 09/08/2023
• 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: 58 YR
• Patient Sex: Male