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 Joint Laxity (4526)

Event Date 04/16/2024

Event Type  Injury  

Event Description

Notified that dr.(b)(6) will be revising an implant in patient (b)(6) due to a failure of the connection component.Patient presented at hospital after disassociation while walking.Revision performed on (b)(6) 2024.Connection component bushing were damaged and set screw was sitting proud.

• 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: 19176263
• MDR Text Key: 340970795
• Report Number: 3006721341-2024-00009
• 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: 04/17/2024,04/24/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/24/2024
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 16-2840/02
• Device Catalogue Number: 16-2840/02
• Device Lot Number: 180816
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 04/16/2024
• Device Age: 5 YR
• Event Location: Hospital
• Date Report to Manufacturer: 04/17/2024
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 64 YR
• Patient Sex: Male