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

Model Number 15-3816/11

Device Problem Detachment of Device or Device Component (2907)

Patient Problem Joint Laxity (4526)

Event Date 11/02/2022

Event Type  Injury  

Event 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
• Type of Device: ENDO-MODEL MODULAR KNEE PROSTHESIS SYSTEM
• Manufacturer (Section D): WALDEMAR LINK GMBH & CO. KG; barkhausenweg 10; hamburg, 22339 ; GM 22339
• MDR Report Key: 17447167
• MDR Text Key: 320287050
• Report Number: 3006721341-2023-00019
• Device Sequence Number: 1
• Product Code: KRO
• UDI-Device Identifier: 04026575034741
• UDI-Public: (01)04026575034741(17)260930
• 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: 07/26/2023,08/02/2023

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 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 Manufacturer Received: Not provided
• Initial Date FDA Received: 08/02/2023
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 76 YR
• Patient Sex: Female
• Patient Weight: 109 KG