MAUDE Adverse Event Report: ENDO-MODEL SL KNEE JOINT PROSTHESIS; MODULAR STEM, UNCEMENTED, MALE TAPER, TI6AL4V, CONICAL, L=160 MM, Ø19 / 14 MM

Model Number 15-8522/57

Device Problems Patient-Device Incompatibility (2682); Osseointegration Problem (3003)

Patient Problem Failure of Implant (1924)

Event Date 01/11/2024

Event Type  Injury  

Event Description

Information received from surgeon (b)(6) 2024 suggests that the design of this cone and stem construct may not have been well suited for this patient: the surgeon noted on (b)(6) 2024 that the wl cones address metaphyseal area but do not address meta-diaphyseal ingrowth, especially when used with cementless stems (as in this case).The subject components were implanted by dr.(b)(6) during revision knee surgery on (b)(6) 2022.Patient complained of pain located in medial and lateral right knee starting after surgery.Due to pain and femoral stem loosening, the patient's knee was revised on (b)(6) 2024.Femoral side implants were replaced with custom-made femoral stem (lbio ref: cus-736, wl ref: (b)(4)), and standard items 15-8521/10 (total condylar replacement) and 15-0027/15 (replacement plateau).[customer].

• Brand Name: ENDO-MODEL SL KNEE JOINT PROSTHESIS
• Type of Device: MODULAR STEM, UNCEMENTED, MALE TAPER, TI6AL4V, CONICAL, L=160 MM, Ø19 / 14 MM
• MDR Report Key: 18719245
• MDR Text Key: 335526328
• Report Number: 3004371426-2024-00011
• Device Sequence Number: 1
• Product Code: KRO
• Combination Product (y/n): N
• PMA/PMN Number: K151008
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Distributor
• Type of Report: Initial
• Report Date: 01/19/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/16/2024
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 15-8522/57
• Device Catalogue Number: 15-8522/57
• Device Lot Number: 2130188
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 01/19/2024
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 09/01/2021
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 63 YR
• Patient Sex: Male