MAUDE Adverse Event Report: ONKOS SURGICAL ELEOS STEM EXTENSION CANAL FILLING; PROSTHESIS, KNEE

Model Number	KSP16100E
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Codes	Failure of Implant (1924); Unspecified Infection (1930)
Date of Event	11/21/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
This report is for one of five devices involved in the event, please refer to report 3013450937-2019-00001, 3013450937-2019-00002, 3013450937-2019-00003, 3013450937-2019-00005 for the others.The device history records, sterilization batch release records, and patient operation notes were reviewed and indicated that all components involved met specification.Should additional information be obtained the report will be supplemented.
Event or Problem Description
Revision surgery performed due to a failed total knee, where the resurfacing femur loosened, and the resurfacing femur and stem extension dissociated.Additionally, it was indicated that the patient had a possible infection.

• Brand Name: ELEOS STEM EXTENSION CANAL FILLING
• Common Device Name: PROSTHESIS, KNEE
• Manufacturer (Section D): ONKOS SURGICAL; 77 east halsey road; parsippany NJ 07054
• MDR Report Key: 8231471
• Report Number: 3013450937-2019-00004
• Device Sequence Number: 1746309
• Product Code: KRO
• UDI-Device Identifier: B278KSP16100E0
• UDI-Public: B278KSP16100E0
• Combination Product (Y/N): N
• Initial Reporter State: AZ
• Initial Reporter Country: US
• PMA/510(K) Number: K161520
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2017
• Device Explanted Year: 2018
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 01/09/2019

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: 03/21/2025
• Device Model Number: KSP16100E
• Device Catalogue Number: KSP16100E
• Device Lot Number: 1696591
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/08/2019
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/10/2018
• Initial Report FDA Received Date: 01/09/2019
• 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: 58 YR