MAUDE Adverse Event Report: ONKOS SURGICAL ELEOS STEM EXTENSION; ELEOS STEM EXTENSION - CANAL FILLING

Model Number	KSP13140E
Medical Device Problem Code	Loose or Intermittent Connection (1371)
Health Effect - Clinical Codes	Bone Fracture(s) (1870); Pain (1994)
Date of Event	07/06/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The device history record was reviewed and indicated that the component met specification.There was no indication that the manufacturing of the components contributed to this complaint.It is unknown if the patient's medical history or a traumatic event could have contributed to the failure of the components and the fracture of the tibia.
Event or Problem Description
The patient underwent a revision surgery on (b)(6) 2020 due to a periprosthetic fracture of the anterior tibia as well as dissociation between the tibial baseplate and the tibial stem extension.The tibial baseplate, stem extension, poly spacer, tibial hinge component, and distal femur axial pin were explanted and replaced with new implants.The periprosthetic fracture was also repaired during the revision.

• Brand Name: ELEOS STEM EXTENSION
• Common Device Name: ELEOS STEM EXTENSION - CANAL FILLING
• Manufacturer (Section D): ONKOS SURGICAL; 77 east halsey road; parsippany, nj
• MDR Report Key: 10373226
• Report Number: 3013450937-2020-00114
• Device Sequence Number: 16917190
• Product Code: KRO
• UDI-Device Identifier: B278KSP13140E0
• UDI-Public: B278KSP13140E0
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K161520
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2020
• Device Explanted Year: 2020
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 08/05/2020

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?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 04/27/2026
• Device Model Number: KSP13140E
• Device Catalogue Number: KSP13140E
• Device Lot Number: 1735025
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 08/06/2020
• 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: 60 YR