MAUDE Adverse Event Report: ONKOS SURGICAL ELEOS; CEMENTED STEM EXTENSION, 12X65MM

Model Number	KSC01265E
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Unspecified Infection (1930)
Date of Event	04/10/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that the patient developed an alleged infection.The patient underwent a revision surgery on (b)(6) 2023 where the following eleos implants were explanted: two cemented stem extensions, tibial hinge component, resurfacing femur axial pin, poly spacer, tibial baseplate, tibial baseplate tapered screw, resurfacing femur, and resurfacing femur tapered screw.The surgeon placed an antibiotic spacer.No additional information regarding this adverse event has been reported.
Additional Manufacturer Narrative
The investigation is in process.The device will not be returned for evaluation.When the investigation is complete, a supplemental mdr will be submitted accordingly.Multiple mdrs were submitted for this event: #3013450937-2023-00063, #3013450937-2023-00064, #3013450937-2023-00066, #3013450937-2023-00067, #3013450937-2023-00068, #3013450937-2023-00069, #3013450937-2023-00070, #3013450937-2023-00071.
Event or Problem Description
It was reported that the patient developed an alleged infection.The patient underwent a revision surgery on (b)(6) 2023 where the following eleos implants were explanted: two cemented stem extensions, tibial hinge component, resurfacing femur axial pin, poly spacer, tibial baseplate, tibial baseplate tapered screw, resurfacing femur, and resurfacing femur tapered screw.The surgeon placed an antibiotic 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 were reviewed and there were no non-conformances identified that would have contributed to this adverse event.If any additional information is obtained, a supplemental mdr will be filed accordingly.The following sections were updated: h3: device evaluated by manufacturer updated to no.H6: type of investigation code updated to 3331: analysis of production records.H6: type of investigation code updated to 4109: historical data analysis.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: investigation findings code updated to 3221: no findings available.H6: investigation conclusions code updated to 4315: cause not established.

• Brand Name: ELEOS
• Common Device Name: CEMENTED STEM EXTENSION, 12X65MM
• 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 ; 9732645400
• MDR Report Key: 16899525
• Report Number: 3013450937-2023-00065
• Device Sequence Number: 14795550
• Product Code: KRO
• UDI-Device Identifier: B278KSC01265E0
• UDI-Public: B278KSC01265E0
• 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: 2022
• 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): 05/31/2023

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: KSC01265E
• Device Catalogue Number: KSC01265E
• Device Lot Number: 1902588
• 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: 04/10/2023
• Supplement Date Received by Manufacturer: 05/31/2023
• Initial Report FDA Received Date: 05/09/2023
• Supplement Report FDA Received Date: 05/31/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 10/29/2021
• 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 25002114E, ELEOS RESURFACING FEMUR AXIAL PIN; P/N KSC01530E, ELEOS STEM EXTENSION; P/N RF-L004E-01M, ELEOS RESURFACING FEMUR; P/N RF-TSCRW-01M, ELEOS RESURFACING FEMUR SCREW; P/N TB-2204E-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: 65 YR
• Patient Sex: Male