MAUDE Adverse Event Report: ONKOS SURGICAL ELEOS; CANAL-FILLING STEM EXTENSION, 16X100MM

Model Number	KSP15100E
Medical Device Problem Code	Loosening of Implant Not Related to Bone-Ingrowth (4002)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	03/15/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
The patient underwent a revision surgery on (b)(6) 2023 due to a suspected stem loosening.It was reported that in the original surgery, the patient was implanted with a 16x100mm canal-filling stem extension.The surgeon revised the 16x100mm canal-filling stem extension to a 16x140mm canal-filling stem extension.During the revision surgery, the surgeon also implanted the following eleos implants: tibial hinge component, tibial baseplate, tibial baseplate tapered screw, tibial block augment, distal femur axial pin, and tibial poly spacer.There were no alleged malfunctions with the tibial hinge component, tibial baseplate, tibial baseplate tapered screw, tibial block augment, distal femur axial pin, and tibial poly spacer.No additional information regarding this adverse event has been reported.
Additional Manufacturer Narrative
The investigation is in process.When the investigation is complete, a supplemental mdr will be submitted accordingly.
Event or Problem Description
The patient underwent a revision surgery on (b)(6) 2023 due to a suspected stem loosening.It was reported that in the original surgery, the patient was implanted with a 16x100mm canal-filling stem extension.The surgeon revised the 16x100mm canal-filling stem extension to a 16x140mm canal-filling stem extension.During the revision surgery, the surgeon also implanted the following eleos implants: tibial hinge component, tibial baseplate, tibial baseplate tapered screw, tibial block augment, distal femur axial pin, and tibial poly spacer.There were no alleged malfunctions with the tibial hinge component, tibial baseplate, tibial baseplate tapered screw, tibial block augment, distal femur axial pin, and tibial poly spacer.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 could not be reviewed as the lot information of the part is unknown.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 4109: historical data analysis h6: type of investigation code updated to 4110: trend analysis h6: type of investigation code updated to 4114: device not returned h6: investigation findings code updated to 3221: no findings available h6: investigation conclusions code updated to 4315: cause not established h10: additional narratives/data.

• Brand Name: ELEOS
• Common Device Name: CANAL-FILLING STEM EXTENSION, 16X100MM
• Manufacturer (Section D): ONKOS SURGICAL; 77 east halsey road; parsippany NJ 07054
• Manufacturer (Section G): MICROPORT ORTHOPEDICS; 5677 airline rd; arlington TN 38002
• Manufacturer Contact: sara dailey ; 77 east halsey road; parsippany, NJ 07054 ; 8447672766
• MDR Report Key: 16727855
• Report Number: 3013450937-2023-00059
• Device Sequence Number: 15277072
• Product Code: KRO
• UDI-Device Identifier: B278KSP15100E0
• UDI-Public: B278KSP15100E0
• Combination Product (Y/N): N
• Initial Reporter State: NY
• Initial Reporter Country: US
• PMA/510(K) Number: K161520
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Explanted Year: 2023
• 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): 06/12/2023

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 Model Number: KSP15100E
• Device Catalogue Number: KSP15100E
• 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: 03/13/2023
• Supplement Date Received by Manufacturer: 06/09/2023
• Initial Report FDA Received Date: 04/12/2023
• Supplement Report FDA Received Date: 06/12/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• 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 25001208E, ELEOS TIBIAL POLY SPACER.; P/N 25002111E, ELEOS DISTAL FEMUR AXIAL PIN.; P/N KTAGB315E, ELEOS TIBIAL BLOCK AUGMENT.; P/N TB-2203E-01M, ELEOS TIBIAL BASEPLATE.; P/N TB-TSCRW-01M, ELEOS TIBIAL BASEPLATE SCREW.; P/N THSMWRS01M, ELEOS TIBIAL HINGE COMPONENT.
• Outcome Attributed to Adverse Event: Hospitalization
• Patient Age: 57 YR
• Patient Sex: Female