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

Model Number 16-2853/22

Device Problem Detachment of Device or Device Component (2907)

Patient Problem Joint Dislocation (2374)

Event Date 11/25/2023

Event Type  Injury  

Event Description

As reported by representative (b)(6) on 2023-11-27, a patient presented to the emergency room on wednesday (b)(6) 2023 and was found to have a dislocated endo sl component.Revision surgery took place on (b)(6) 2023 and was very 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: 18327764
• MDR Text Key: 330546675
• Report Number: 3006721341-2023-00024
• 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: 11/27/2023,12/14/2023

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
• Device Operator: Health Professional
• Device Expiration Date: 02/28/2022
• Device Model Number: 16-2853/22
• Device Catalogue Number: 16-2853/22
• Device Lot Number: 110707
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 11/27/2023
• Event Location: Hospital
• Date Report to Manufacturer: 11/27/2023
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 12/14/2023
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 66 YR
• Patient Sex: Female