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

Model Number 16-2840/02

Device Problem Detachment of Device or Device Component (2907)

Patient Problem Failure of Implant (1924)

Event Date 12/19/2023

Event Type  Injury  

Event Description

Notified on 12/19/23 regarding a revision case with dr.(b)(6).On (b)(6) 2023 for what was thought to be a failed connection component.At surgery, it was found that the connection component was intact but the plastic bearings were broken in the femur.The revision replaced the connection component and bearings and the outcome was successful.

• Brand Name: ENDO-MODEL SL KNEE PROSTHESIS SYSTEM
• Type of Device: ENDO-MODEL SL KNEE PROSTHESIS SYSTEM
• Manufacturer (Section D): WALDEMAR LINK GMBH & CO. KG; barkhausenweg 10; hamburg, 22339 ; GM 22339
• MDR Report Key: 18477812
• MDR Text Key: 332493805
• Report Number: 3006721341-2024-00001
• Device Sequence Number: 1
• Product Code: KRO
• 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: 12/20/2023,01/09/2024

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
• Device Model Number: 16-2840/02
• Device Catalogue Number: 16-2840/02
• Device Lot Number: 190228
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 12/19/2023
• Event Location: Hospital
• Date Report to Manufacturer: 12/20/2023
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 01/09/2024
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention