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 01/06/2023

Event Type  Injury  

Event Description

This tinbn-coated hinged knee was implanted (b)(6) 2022 (femoral components and tibial plateau) and (b)(6) 2022 (tibial tray and stem) as a temporary spacer for the 1st stage in a planned 2 stage revision for infection (with definitive prosthesis to be custom-made by another supplier).This tinbn-coated hinged knee was used as a temporary spacer because of the patient's nickel allergy.The patient presented to the er and underwent revision surgery (b)(6) 2023 due to dissociation of the femoral component from femoral stem.The femoral stem, femoral augment, femoral component, and tibial plateau were replaced, with the construct still being intended as a temporary spacer, anticipating later conversion to definitive custom-made implants.Prior surgeries on this knee include: primary and revision tka (not link product), revision with link compassionate use components (b)(6) 2022 ((b)(4)), and subsequent revisions (b)(6) 2022 and (b)(6) 2022 for infection (previously reported in complaint (b)(4)) and for dissociation of femoral component from stem (same stem as previous event 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: 17445501
• MDR Text Key: 320251536
• Report Number: 3006721341-2023-00020
• Device Sequence Number: 1
• Product Code: KRO
• UDI-Device Identifier: 04026575034741
• UDI-Public: (01)04026575034741(17)270131
• 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 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