MAUDE Adverse Event Report: MICROPORT ORTHOPEDICS ELEOS; CANAL-FILLING STEM EXTENSION, 18MM X 140MM

Model Number	KSP17140E
Medical Device Problem Code	Loosening of Implant Not Related to Bone-Ingrowth (4002)
Health Effect - Clinical Code	Insufficient Information (4580)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
This report is being submitted to include additional information that was received on 15 feb 2023.The investigation was reopened to address the new information and is now complete.The device was not returned for evaluation.The root cause of the loosening could not be determined.If any additional information is obtained, a supplemental mdr will be filed accordingly.Mdrs associated with this event include:3013450937-2022-00390.
Event or Problem Description
It was reported that the resurfacing femur and stem extension had become loose due to poor bone quality.A revision surgery was performed on (b)(6) 2022 where the patient's hinge knee replacement system was revised to a distal femoral replacement system.

• Brand Name: ELEOS
• Common Device Name: CANAL-FILLING STEM EXTENSION, 18MM X 140MM
• Manufacturer (Section D): MICROPORT ORTHOPEDICS; 5677 airline road; arlington TN 38002
• Manufacturer (Section G): MICROPORT ORTHOPEDICS; 5677 airline road; arlington TN 38002
• Manufacturer Contact: danielle pierce ; 77 east halsey road; parsippany, NJ 07054 ; 8447672766
• MDR Report Key: 16566190
• Report Number: 3013450937-2023-00044
• Device Sequence Number: 5423450
• Product Code: KRO
• UDI-Device Identifier: B278KSP17140E0
• UDI-Public: B278KSP17140E0
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: K161520
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2020
• Device Explanted Year: 2022
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 03/17/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: No
• Device Expiration Date: 03/27/2025
• Device Model Number: KSP17140E
• Device Catalogue Number: KSP17140E
• Device Lot Number: 1703766
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/15/2023
• Initial Report FDA Received Date: 03/17/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 03/27/2017
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: 2500L002E ELEOS RESURFACING FEMUR, SIZE 2, LEFT.
• Outcome Attributed to Adverse Event: Hospitalization
• Patient Age: 56 YR
• Patient Sex: Female