MAUDE Adverse Event Report: ONKOS SURGICAL ELEOS; CANAL-FILLING STEM EXTENSION, 11X140MM, STRAIGHT

Model Number	KSP10140E
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Joint Laxity (4526)
Date of Event	12/16/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The investigation is in process.The device is expected to be returned for evaluation.When the investigation is complete, a supplemental mdr will be submitted accordingly.Multiple mdr reports were submitted for this event: #3013450937-2022-00001.
Event or Problem Description
It was reported that the patient underwent a revision surgery on (b)(6) 2021.The patient presented with varus/valgus instability.During the revision surgery, it was observed that the stem extension dissociated from the resurfacing femur.It was observed that the boss of the resurfacing femur was cracked.The surgeon debrided the wound and explanted the following implants: poly spacer, resurfacing femur, tibial hinge component, resurfacing femur axial pin, and stem extension.The surgeon placed a distal femoral replacement system.No additional information regarding this adverse event has been reported.
Additional Manufacturer Narrative
This report is being submitted to include additional information.The investigation is complete.The device was not returned for evaluation.The device history records and sterilization batch records were reviewed and no issues during manufacturing or sterilization were identified that would have contributed to this complaint.The root cause of the reported event could not be determined.If any additional information is obtained, a supplemental mdr will be filed accordingly.The following sections were updated: b4: date of this report added.G3: date received by manufacturer added.G6: type of report added.H2: follow-up type added.H3: device evaluated by manufacturer updated to no.H6: type of investigation code updated to 3111: analysis of production records.H6: type of investigation code updated to 4111: communication/interviews.H6: type of investigation code updated to 4110: trend analysis.H6: type of investigation code updated to 4114: device not returned.H6: type of investigation code updated to 4117: device not accessible for testing.H6: type of investigation code updated to 4109: historical data analysis.H6: investigation findings code updated to 213: no device problem found.H6: investigation conclusions code updated to 4315: cause not established.H10: additional narratives/data.
Event or Problem Description
It was reported that the patient underwent a revision surgery on (b)(6) 2021.The patient presented with varus/valgus instability.During the revision surgery, it was observed that the stem extension dissociated from the resurfacing femur.It was observed that the boss of the resurfacing femur was cracked.The surgeon debrided the wound and explanted the following implants: poly spacer, resurfacing femur, tibial hinge component, resurfacing femur axial pin, and stem extension.The surgeon placed a distal femoral replacement system.No additional information regarding this adverse event has been reported.

• Brand Name: ELEOS
• Common Device Name: CANAL-FILLING STEM EXTENSION, 11X140MM, STRAIGHT
• Manufacturer (Section D): ONKOS SURGICAL; 77 east halsey road; parsippany NJ 07054
• Manufacturer (Section G): MICROPORT ORTHOPEDICS; 5677 airline road; arlington TN 38002
• Manufacturer Contact: sara dailey ; 77 east halsey road; parsippany, NJ 07054
• MDR Report Key: 13168649
• Report Number: 3013450937-2022-00002
• Device Sequence Number: 5422663
• Product Code: KRO
• UDI-Device Identifier: B278KSP10140E0
• UDI-Public: B278KSP10140E0
• Combination Product (Y/N): N
• Initial Reporter State: IL
• Initial Reporter Country: US
• PMA/510(K) Number: K161520
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2018
• Device Explanted Year: 2021
• 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): 03/09/2022

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
• Operator of Device: Health Professional
• Device Expiration Date: 03/19/2025
• Device Model Number: KSP10140E
• Device Catalogue Number: KSP10140E
• Device Lot Number: 1695382
• 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: 12/09/2021
• Supplement Date Received by Manufacturer: 03/09/2022
• Initial Report FDA Received Date: 01/05/2022
• Supplement Report FDA Received Date: 03/09/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 03/19/2017
• 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: P/N 25001220E, ELEOS TIBIAL POLY SPACER.; P/N 25002100E, ELEOS TIBIAL HINGE COMPONENT.; P/N 25002112E, ELEOS RESURFACING FEMUR AXIAL PIN.; P/N 2500R002E, ELEOS RESURFACING FEMUR.
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention
• Patient Age: 20 YR
• Patient Sex: Female