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

Model Number	15-8521/06
Medical Device Problem Codes	Naturally Worn (2988); Positioning Problem (3009)
Health Effect - Clinical Code	Failure of Implant (1924)
Date of Event	12/12/2023
Type of Reportable Event	Serious Injury
Event or Problem 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 or Problem 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].
Additional 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
• Common Device Name: 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
• Report Number: 3004371426-2024-00001
• Device Sequence Number: 15048812
• Product Code: KRO
• UDI-Device Identifier: 04026575383191
• UDI-Public: 04026575383191
• Combination Product (Y/N): N
• Initial Reporter State: NJ
• Initial Reporter Country: US
• PMA/510(K) Number: K143179
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2023
• Device Explanted Year: 2024
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Distributor
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 12/19/2023

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?: No
• Operator of Device: 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
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/19/2023
• Supplement Date Received by Manufacturer: 12/19/2023
• Initial Report FDA Received Date: 01/17/2024
• Supplement Report FDA Received Date: 04/10/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/01/2022
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 71 YR
• Patient Sex: Male