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

Model Number	15-3816/11
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	Joint Laxity (4526)
Date of Event	11/02/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
This tinbn-coated hinged knee was implanted on (b)(6) 2022 as a temporary spacer for the 1st stage in a planned 2 stage revision for infection.This tinbn-coated hinged knee was used as a spacer because of the patient's nickel allergy.The patient underwent revision surgery on (b)(6) 2022.Operative finding was "what appeared to be a disassociated component, which was unclear as to the source." disassociation was between the distal femoral component and the femoral stem.The femoral component, tibial polyethylene bearing, and femoral augment were replaced (impacted onto the existing femoral stem in situ).Prior surgeries on this knee include: primary and revision tka (not link product), revision with link compassionate use components on (b)(6) 2022 (b)(4), and subsequent revisions on (b)(6) 2022 for infection (previously reported in complaint (b)(4)).

• Brand Name: ENDO-MODEL MODULAR KNEE PROSTHESIS SYSTEM
• Common Device Name: ENDO-MODEL MODULAR KNEE PROSTHESIS SYSTEM
• Manufacturer (Section D): WALDEMAR LINK GMBH & CO. KG; barkhausenweg 10; hamburg, 22339 ; GM 22339
• MDR Report Key: 17447167
• Report Number: 3006721341-2023-00019
• Device Sequence Number: 20655155
• Product Code: KRO
• UDI-Device Identifier: 04026575034741
• UDI-Public: (01)04026575034741(17)260930
• Combination Product (Y/N): N
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2022
• Device Explanted Year: 2022
• Serviced by Third Party (Y/N): N
• Reporter Type: Importer
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 08/02/2023
• Report Date (Section F): 07/26/2023

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
• Operator of Device: Health Professional
• Device Expiration Date: 09/30/2026
• Device Model Number: 15-3816/11
• Device Catalogue Number: 15-3816/11
• Device Lot Number: 200818
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 07/25/2023
• Event Location: Hospital
• Date Report to Manufacturer: 07/26/2023
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 08/02/2023
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 76 YR
• Patient Sex: Female
• Patient Weight: 109 KG