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

Model Number 15-0027/14

Device Problem Detachment of Device or Device Component (2907)

Patient Problem Ambulation Difficulties (2544)

Event Type  Injury  

Event Description

Patient presented with difficulty walking, combined with clicking and locking in the right knee subsequent to a dec 2022 tka (revision).X-rays shows some offset of femur with respect to the tibial plateau.Both the femoral and tibial components appear securely fixed on x-ray.Revision surgery is scheduled for 01/23/2024.

• Brand Name: ENDO-MODEL STANDARD KNEE PROSTHESIS SYSTEM
• Type of Device: ENDO-MODEL STANDARD KNEE PROSTHESIS SYSTEM
• Manufacturer (Section D): WALDEMAR LINK GMBH & CO. KG; barkhausenweg 10; hamburg, 22339 ; GM 22339
• MDR Report Key: 18477841
• MDR Text Key: 332459681
• Report Number: 3006721341-2024-00002
• Device Sequence Number: 1
• Product Code: KRO
• UDI-Device Identifier: 04026575432110
• UDI-Public: (01)04026575432110(17)270731(10)
• 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: 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 Operator: Health Professional
• Device Model Number: 15-0027/14
• Device Catalogue Number: 15-0027/14
• Device Lot Number: 2231118
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 12/12/2023
• Device Age: 1 YR
• Date Report to Manufacturer: 01/09/2024
• 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
• Patient Age: 71 YR
• Patient Sex: Male