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

Model Number 15-3950/06

Device Problem Detachment of Device or Device Component (2907)

Patient Problems Joint Laxity (4526); Implant Pain (4561)

Event Date 08/14/2023

Event Type  Injury  

Event 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
• Type of Device: ENDO-MODEL MODULAR KNEE PROSTHESIS SYSTEM
• Manufacturer (Section D): WALDEMAR LINK GMBH & CO. KG; barkhausenweg 10; hamburg, 22339 ; GM 22339
• MDR Report Key: 17709931
• MDR Text Key: 322931948
• Report Number: 3006721341-2023-00022
• Device Sequence Number: 1
• Product Code: KRO
• UDI-Device Identifier: 04026575431687
• UDI-Public: (01)04026575431687(17)261031(10)2164333
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Distributor
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 08/22/2023,09/08/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/08/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: 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
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 58 YR
• Patient Sex: Male