MAUDE Adverse Event Report: WALDEMAR LINK GMBH & CO.KG ENDO-MODEL; FEMORAL COMPONENTS,CONDYLAR REPLACEMENTLINK® MEGASYSTEM-C,SMALL, RIGHT

Model Number 15-8521/06

Device Problems Naturally Worn (2988); Positioning Problem (3009)

Patient Problem Failure of Implant (1924)

Event Date 12/12/2023

Event Type  Injury  

Event Description

"patient presented with difficulty walking, combined with clicking and locking in the right knee subsequent to a (b)(6) 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 (b)(6) 2024.".

Event Description

(b)(6).Patient presented with difficulty walking, combined with clicking and locking in the right knee subsequent to a on (b)(6) 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 on (b)(6) 2024.Additional information will be updated after surgery.Update 03/13/2024: (b)(6) confirmed that the revision planned for on (b)(6) 2024 took place.Dr.(b)(6) replaced the femoral component and tibial poly.The explanted devices were not released by the hospital.A request has been made for the operative report.(b)(6) noted that this patient has no extensor mechanism.Intraoperatively, he observed that the polyethylene thimble in the post had worn through on the anterior side seemingly from the shear force of the femur on the post related to lack of extensor mechanism.No photos were available.On (b)(6) 2024, usage form provided.[customer].

Manufacturer Narrative

According to the investigation the suspected medical device was changed from 15-0027/14 to 15-8521/06.This is the final supplemental report, the complaint is closed.

• Brand Name: ENDO-MODEL
• Type of Device: FEMORAL COMPONENTS,CONDYLAR REPLACEMENTLINK® MEGASYSTEM-C,SMALL, RIGHT
• Manufacturer (Section D): WALDEMAR LINK GMBH & CO.KG; barkhausenweg 10; hamburg, 22339 ; GM 22339
• Manufacturer Contact: annerike tizia hucklenbroch ; barkhausenweg 10; hamburg, 22339 ; GM 22339
• MDR Report Key: 18525512
• MDR Text Key: 333029497
• Report Number: 3004371426-2024-00001
• Device Sequence Number: 1
• Product Code: KRO
• UDI-Device Identifier: 04026575383191
• UDI-Public: 04026575383191
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K143179
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Distributor
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 12/19/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/17/2024
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 15-8521/06
• Device Catalogue Number: 15-8521/06
• Device Lot Number: 2231118
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 12/19/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/01/2022
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 71 YR
• Patient Sex: Male