MAUDE Adverse Event Report: ONKOS SURGICAL ELEOS; STEM EXTENSION, CEMENTED, 15MM X 30MM, STRAIGHT, BULLET-TIP

Model Number	KSC01530E
Health Effect - Clinical Code	Unspecified Infection (1930)
Date of Event	11/19/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The root cause for the infection was unable to be determined.It was reported by the sales representative that the amputation of the patient's limb was the patient's choice and the patient could have opted for a revision surgery to address the infection without amputation.The patient's medical history is unknown.Based on review of the device history records and sterilization batch release records, it was concluded that the failure was not associated with the manufacture or sterilization of the implants or a nonconformance.
Event or Problem Description
A patient underwent an amputation surgery performed by dr.(b)(6) on (b)(6) 2020 due to an alleged infection of eleos components.Instead of revision, the patient opted for amputation of the limb above the knee.The patient underwent his primary eleos surgery on (b)(6) 2019 where he underwent a revision of a total knee arthroplasty.The following implants were placed during the primary eleos surgery, and were removed during the amputation surgery: a tibial baseplate, two tibial block augments, two cemented stem extensions, a resurfacing femur, a resurfacing femur axial pin, a tibial hinge component, and a tibial poly spacer.

• Brand Name: ELEOS
• Common Device Name: STEM EXTENSION, CEMENTED, 15MM X 30MM, STRAIGHT, BULLET-TIP
• Manufacturer (Section D): ONKOS SURGICAL; 77 east halsey road; parsippany NJ 07054
• MDR Report Key: 11015804
• Report Number: 3013450937-2020-00185
• Device Sequence Number: 19479410
• 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: 2019
• Device Explanted Year: 2020
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 12/15/2020

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: 1811374
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/19/2020
• Initial Report FDA Received Date: 12/16/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 68 YR