MAUDE Adverse Event Report: MICROPORT ORTHOPEDICS ELEOS; RESURFACING FEMUR, SIZE 2, LEFT

Model Number	2500L002E
Medical Device Problem Codes	Insufficient Device Problem Information (3190); Loosening of Implant Not Related to Bone-Ingrowth (4002)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	11/17/2022
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The investigation is in progress.When it is complete a supplemental mdr will be submitted accordingly.
Event or Problem Description
It was reported on (b)(6) 2022 that a revision surgery was scheduled for (b)(6) 2022 for a patient that had onkos devices implanted.The reason for this revision surgery and product details were not provided.The revision surgery was cancelled and has not been rescheduled.Attempts have been made and no other information has been made available.
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.
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: 3013450937-2023-00044.

• Brand Name: ELEOS
• Common Device Name: RESURFACING FEMUR, SIZE 2, LEFT
• Manufacturer (Section D): MICROPORT ORTHOPEDICS; 5677 airline road; arlington TN 38002
• Manufacturer Contact: danielle pierce ; 77 east halsey road; parsippany, NJ 07054 ; 8447672766
• MDR Report Key: 15999842
• Report Number: 3013450937-2022-00390
• Device Sequence Number: 20497171
• Product Code: KRO
• UDI-Device Identifier: B2782500L002E0
• UDI-Public: B2782500L002E0
• 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): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• 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?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Expiration Date: 11/01/2025
• Device Model Number: 2500L002E
• Device Catalogue Number: 2500L002E
• Device Lot Number: 1731604
• 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: 11/17/2022
• Supplement Date Received by Manufacturer: 02/15/2023
• Initial Report FDA Received Date: 12/16/2022
• Supplement Report FDA Received Date: 03/17/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 11/01/2017
• 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: KSP17140E ELEOS CANAL-FILLING STEM EXTENSION
• Outcome Attributed to Adverse Event: Hospitalization
• Patient Age: 56 YR
• Patient Sex: Female