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

Model Number 15-2964/06

Device Problem Detachment of Device or Device Component (2907)

Patient Problem Implant Pain (4561)

Event Date 04/27/2023

Event Type  Injury  

Event Description

On (b)(6) 2023, dr.(b)(6) office forwarded patient chart notes from an office visit on (b)(6) 2023, where dr.(b)(6) indicates that the patient needs femoral-side revision due to pain and audible clicking that dr.(b)(6) believes is related to movement at the uhmwpe femoral augment.This patient has nickel allergy and has had several prior tkr, including 2015 (aesculap), revision on (b)(6) 2022 with link tinbn-coated components provided under compassionate use ((b)(4)), and subsequent femoral-side revision on (b)(6) 2022 with link commercially-available components which was the subject of previous event report (linkbio ref (b)(4)).

Event Description

On 2023-07-18, dr.(b)(6) office forwarded patient chart notes from an office visit on (b)(6) 2023, where dr.(b)(6) indicates that the patient needs femoral-side revision due to pain and audible clicking that dr.(b)(6) believes is related to movement at the uhmwpe femoral augment.This patient has nickel allergy and has had several prior tkr, including 2015 (aesculap), revision on (b)(6) 2022 with link tinbn-coated components provided under compassionate use (b)(4), and subsequent femoral-side revision on (b)(6) 2022 with link commercially-available components which was the subject of previous event report (linkbio ref 2022-052).2024-02-26 updated information from notification from dr.(b)(6) on (b)(6) 2024: previously reported information in this report was notice of a planned revision, but was confirmed that a revision did occur with removal of all previous implants (link dfr) on (b)(6) 2023, due to infection.This revision was performed by a different surgeon, dr.B.Who implanted an articulating spacer (non-link product).

• 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: 17437326
• MDR Text Key: 320207110
• Report Number: 3006721341-2023-00018
• Device Sequence Number: 1
• Product Code: KRO
• 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,Followup
• Report Date: 08/01/2023

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: 15-2964/06
• Device Catalogue Number: 15-2964/06
• Device Lot Number: 2122177
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 08/01/2023
• Distributor Facility Aware Date: 07/18/2023
• Event Location: Hospital
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 08/01/2023
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 02/27/2024
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 61 YR
• Patient Sex: Male
• Patient Weight: 109 KG