MAUDE Adverse Event Report: ONKOS SURGICAL ELEOS; STEM EXTENSION, CANAL FILLING, 13X100MM, STRIAGHT, SPLINED, SLOTTED

Model Number	KSP12100E
Medical Device Problem Codes	Adverse Event Without Identified Device or Use Problem (2993); Appropriate Device Problem Term/Code Not Available (3191)
Health Effect - Clinical Code	Unspecified Infection (1930)
Date of Event	05/12/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The device will not be returned for investigation as it was discarded at the hospital.The investigation is in progress.When the investigation is complete, a supplemental report will be submitted accordingly.Multiple mdrs were reported for this event: #3013450937-2021-00110, #3013450937-2021-00111, #3013450937-2021-00112, #3013450937-2021-00113, #3013450937-2021-00114, #3013450937-2021-00115.
Event or Problem Description
It was reported that the patient underwent a revision surgery on (b)(6) 2021 due to an alleged infection.During this revision surgery, the surgeon explanted the following components: a tibial hinge component, a tibial poly spacer, and a distal femur axial pin.The following implants were also implanted in the patient at the time of the infection and revision surgery: a segmental stem, a tibial baseplate, a distal femur component, and a stem extension.The surgeon performed a washout of the area and revised all of the implants that contained poly components.No further information regarding this event has been obtained.
Event or Problem Description
It was reported that the patient underwent a revision surgery on (b)(6) 2021 due to an alleged infection.During this revision surgery, the surgeon explanted the following components: a tibial hinge component, a tibial poly spacer, and a distal femur axial pin.The following implants were also implanted in the patient at the time of the infection and revision surgery: a segmental stem, a tibial baseplate, a distal femur component, and a stem extension.The surgeon performed a washout of the area and revised all of the implants that contained poly components.No further information regarding this event has been obtained.
Additional Manufacturer Narrative
The investigation is complete.The device was not returned for evaluation.The root cause of the patient undergoing a revision surgery due to an 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 could 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.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 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.

• Brand Name: ELEOS
• Common Device Name: STEM EXTENSION, CANAL FILLING, 13X100MM, STRIAGHT, SPLINED, SLOTTED
• Manufacturer (Section D): ONKOS SURGICAL; 77 east halsey road; parsippany NJ 07054
• MDR Report Key: 11966887
• Report Number: 3013450937-2021-00116
• Device Sequence Number: 3661037
• Product Code: KRO
• UDI-Device Identifier: B278KSP12100E0
• UDI-Public: B278KSP12100E0
• Combination Product (Y/N): N
• Initial Reporter State: KY
• Initial Reporter Country: US
• PMA/510(K) Number: K161520
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2020
• 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): 07/14/2021

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 Expiration Date: 07/21/2026
• Device Model Number: KSP12100E
• Device Catalogue Number: KSP12100E
• Device Lot Number: 1761654
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/12/2021
• Supplement Date Received by Manufacturer: 07/12/2021
• Initial Report FDA Received Date: 06/09/2021
• Supplement Report FDA Received Date: 07/14/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: 25000007E- DISTAL FEMUR; 25001208E, TIBIAL POLY SPACER; 25002100E- TIBIAL HINGE COMPONENT; 25002100E- TIBIAL HINGE COMPONENT; 25002111E- DISTAL FEMUR AXIAL PIN; 25004011E- SEGMENTAL STEM; 25000007E- DISTAL FEMUR; 25001208E, TIBIAL POLY SPACER; 25002100E- TIBIAL HINGE COMPONENT; 25002100E- TIBIAL HINGE COMPONENT; 25002111E- DISTAL FEMUR AXIAL PIN; 25004011E- SEGMENTAL STEM
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention
• Patient Age: 74 YR