MAUDE Adverse Event Report: ONKOS SURGICAL ELEOS; CEMENTED STEM EXTENSION, 15X30MM

Model Number	KSC01530E
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Hematoma (1884); Unspecified Infection (1930); Pain (1994)
Date of Event	08/24/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that the patient was experiencing pain and developed an alleged infection and hematomas.The patient underwent a revision surgery on (b)(6) 2022 where the following eleos implants were revised: tibial poly spacer, tibial hinge component, and distal femur axial pin.The following eleos implants remain implanted from the patient's original surgery: distal femur, tibial baseplate, and cemented stem extension.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: #3013450937-2022-00259, #3013450937-2022-00260, #3013450937-2022-00262, #3013450937-2022-00263, #3013450937-2022-00264.
Additional Manufacturer Narrative
This report is being submitted to include additional information.The investigation is complete.The device was not returned for evaluation.The root cause of the pain, alleged infection and hematoma 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 4110: trend analysis h6: type of investigation code updated to 4117: device not accessible for testing h6: type of investigation code updated to 3331: analysis of production records h6: type of investigation code updated to 4111: communication/interviews h6: type of investigation code updated to 4109: historical data analysis h6: investigation findings code updated to 3221: no findings available h6: investigation conclusions code updated to 4315: cause not established h10: additional narratives/data.
Event or Problem Description
It was reported that the patient was experiencing pain and developed an alleged infection and hematomas.The patient underwent a revision surgery on (b)(6) 2022 where the following eleos implants were revised: tibial poly spacer, tibial hinge component, and distal femur axial pin.The following eleos implants remain implanted from the patient's original surgery: distal femur, tibial baseplate, and cemented stem extension.No additional information regarding this adverse event has been reported.

• Brand Name: ELEOS
• Common Device Name: CEMENTED STEM EXTENSION, 15X30MM
• 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: 15477989
• Report Number: 3013450937-2022-00261
• Device Sequence Number: 12279697
• Product Code: KRO
• UDI-Device Identifier: B278KSC01530E0
• UDI-Public: B278KSC01530E0
• Combination Product (Y/N): N
• Initial Reporter State: NC
• Initial Reporter Country: US
• PMA/510(K) Number: K161520
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted 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): 12/22/2022

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?: No
• Operator of Device: Health Professional
• Device Model Number: KSC01530E
• Device Catalogue Number: KSC01530E
• Device Lot Number: 1900534
• 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: 08/24/2022
• Supplement Date Received by Manufacturer: 11/22/2022
• Initial Report FDA Received Date: 09/24/2022
• Supplement Report FDA Received Date: 12/22/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 10/18/2021
• 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 25000007E, ELEOS DISTAL FEMUR; P/N 25001208E, ELEOS POLY SPACER; P/N 25002111E, ELEOS DISTAL FEMUR AXIAL PIN; P/N CP3A0123, MICROPORT CUSTOM DEVICE; P/N CP3A0124, MICROPORT CUSTOM DEVICE; P/N TB-2203E-01M, ELEOS TIBIAL BASEPLATE; P/N THSMWRS01M, ELEOS TIBIAL HINGE COMPONENT
• Outcome Attributed to Adverse Event: Hospitalization
• Patient Age: 66 YR
• Patient Sex: Male