MAUDE Adverse Event Report: ONKOS SURGICAL ELEOS; CEMENTED STRAIGHT STEM EXTENSION, 16X100MM

Model Number	KSC16100E
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Fall (1848); Unspecified Infection (1930)
Date of Event	08/05/2022
Type of Reportable Event	Serious Injury
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: #3013450937-2022-00228, #3013450937-2022-00229, #3013450937-2022-00230, #3013450937-2022-00232, #3013450937-2022-00233, #3013450937-2022-00234.
Event or Problem Description
It was reported that the patient fell and opened their incision.The patient underwent a revision surgery on (b)(6) 2022.The surgeon performed incision and drainage and revised the following implants: poly spacer, distal femur axial pin, and tibial hinge component.The following implants remain implanted from the patient's original surgery: distal femur, tibial baseplate, cemented stem extension, and canal-filling segmental stem.No additional information has been provided.
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 fall and alleged infection could not be determined.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.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 3331: 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.
Event or Problem Description
It was reported that the patient fell and opened their incision.The patient underwent a revision surgery on (b)(6) 2022.The surgeon performed incision and drainage and revised the following implants: poly spacer, distal femur axial pin, and tibial hinge component.The following implants remain implanted from the patient's original surgery: distal femur, tibial baseplate, cemented stem extension, and canal-filling segmental stem.No additional information has been provided.

• Brand Name: ELEOS
• Common Device Name: CEMENTED STRAIGHT STEM EXTENSION, 16X100MM
• 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: 15307887
• Report Number: 3013450937-2022-00231
• Device Sequence Number: 2594759
• Product Code: KRO
• UDI-Device Identifier: B278KSC16100E0
• UDI-Public: B278KSC16100E0
• Combination Product (Y/N): N
• Initial Reporter State: TN
• 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): 10/26/2022

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: KSC16100E
• Device Catalogue Number: KSC16100E
• Device Lot Number: 1892073
• 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: 07/30/2022
• Supplement Date Received by Manufacturer: 10/26/2022
• Initial Report FDA Received Date: 08/28/2022
• Supplement Report FDA Received Date: 10/26/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 08/03/2021
• 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 25001210E, ELEOS POLY SPACER; P/N 25002111E, ELEOS DISTAL FEMUR AXIAL PIN; P/N FS-20120-03M, ELEOS CANAL-FILLING STEM; P/N TB-2203E-01M, ELEOS TIBIAL BASEPLATE. SIZE 3; P/N THSMWRS01M, ELEOS TIBIAL HINGE COMPONENT
• Outcome Attributed to Adverse Event: Hospitalization
• Patient Age: 73 YR
• Patient Sex: Female