MAUDE Adverse Event Report: ONKOS SURGICAL ELEOS, STEM EXTENSION, CEMENTED, STRAIGHT; PROSTHESIS, STEM

Model Number	KSC16100E
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Codes	Fall (1848); No Information (3190)
Date of Event	02/09/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The device history record indicated that the released components met all specification.The complaint history review indicated no trends among components by failure modes.Should additional information be obtained to further this investigation, the report will be updated.
Event or Problem Description
Revision surgery performed on eleos resurfacing hinge knee where it appeared on x-rays that the femoral component had dissociated from the stem extension.Upon removal of the components it was discovered that the resurfacing femur had loosened and the wall of the female boss had fractured on one side.
Additional Manufacturer Narrative
This medical device report (mdr) was initiated as part of a retrospective assessment of complaints under onkos surgical capa18-007.As part of this assessment, onkos surgical re-evaluated all complaints received to ensure mdrs were filed when required.The results of this retrospective assessment prompted onkos surgical to file this supplement report.This report is for one of two devices involved in the event, please refer to report 3013450937-2018-00005 for the other.The reported event was confirmed through the operation notes and patient history.The device history records indicated that the released components met all specifications.From the available information it was determined that the adverse event was not related to the manufacture of the implants or a non-conformance and this complaint has been closed.Should additional information be obtained to further this investigation, the report will be updated.
Event or Problem Description
Revision surgery performed on eleos resurfacing hinge knee where it appeared on x-rays that the femoral component had dissociated from the stem extension.Upon removal of the components it was discovered that the resurfacing femur had loosened and the wall of the female boss had fractured on one side.

• Brand Name: ELEOS, STEM EXTENSION, CEMENTED, STRAIGHT
• Common Device Name: PROSTHESIS, STEM
• Manufacturer (Section D): ONKOS SURGICAL; 77 east halsey road; parsippany NJ 07054
• MDR Report Key: 7334931
• Report Number: 3013450937-2018-00004
• Device Sequence Number: 13519684
• Product Code: KRO
• UDI-Device Identifier: B278KSC16100E0
• UDI-Public: B278KSC16100E0
• 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,Followup
• Report Date (Section B): 09/13/2018

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: KSC16100E
• Device Catalogue Number: KSC16100E
• Device Lot Number: 1697274
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 02/12/2018
• Supplement Date Received by Manufacturer: 02/12/2018
• Initial Report FDA Received Date: 03/13/2018
• Supplement Report FDA Received Date: 09/13/2018
• 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