MAUDE Adverse Event Report: ONKOS SURGICAL ELEOS STEM EXTENSION

Model Number	KSP11140E
Medical Device Problem Code	Connection Problem (2900)
Health Effect - Clinical Code	No Information (3190)
Date of Event	06/08/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The device history record and sterilization batch release record were reviewed and indicated that the component met specification.It can be concluded that the manufacturing of the implant was unlikely to cause the adverse event.The sales representative stated that the surgeon stated that the surgical tech most likely did not impact the stem into place hard enough.
Event or Problem Description
The patient's implanted tibial stem component loosened.

• Brand Name: ELEOS STEM EXTENSION
• Common Device Name: ELEOS STEM EXTENSION
• Manufacturer (Section D): ONKOS SURGICAL; 77 east halsey road; parsippany, nj
• MDR Report Key: 10247970
• Report Number: 3013450937-2020-00102
• Device Sequence Number: 536526
• Product Code: KRO
• UDI-Device Identifier: B278KSP11140E0
• UDI-Public: B278KSP11140E0
• 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
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 07/08/2020

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: 03/14/2025
• Device Model Number: KSP11140E
• Device Catalogue Number: KSP11140E
• Device Lot Number: 1695384
• 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: 07/08/2020
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention