MAUDE Adverse Event Report: ONKOS SURGICAL ELEOS SEGMENTAL STEM CEMENTED; PROSTHESIS, KNEE

Model Number	SPSEB011E
Medical Device Problem Code	Loss of Osseointegration (2408)
Health Effect - Clinical Code	Failure of Implant (1924)
Date of Event	10/22/2018
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 that loosened met specification.The component was sent for a dimensional analysis, which the results are pending.Should additional information be obtained the report will be supplemented.
Event or Problem Description
Patient x-rays revealed that the femoral stem had loosened and required medical intervention.
Additional Manufacturer Narrative
The device history record and sterilization batch release record were reviewed and indicated that the component that loosened met specification.The component was sent for a dimensional analysis, which the results are pending.Should additional information be obtained the report will be supplemented.The dimensional analysis was conducted on the segmental stem which revealed that all critical features were within specification.Based upon the device history record, sterilization batch release record, and returned component evaluation it was concluded that the failure was not related to the manufacture of the implant or a nonconformance.
Event or Problem Description
Patient x-rays revealed that the femoral stem had loosened and required medical intervention.

• Brand Name: ELEOS SEGMENTAL STEM CEMENTED
• Common Device Name: PROSTHESIS, KNEE
• Manufacturer (Section D): ONKOS SURGICAL; 77 east halsey road; parsippany NJ 07054
• MDR Report Key: 8068924
• Report Number: 3013450937-2018-00070
• Device Sequence Number: 1593310
• Product Code: KRO
• UDI-Device Identifier: B278SPSEB011E0
• UDI-Public: B278SPSEB011E0
• Combination Product (Y/N): N
• Initial Reporter State: SC
• Initial Reporter Country: US
• PMA/510(K) Number: K161520
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2018
• Device Explanted Year: 2018
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 01/25/2019

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: 07/26/2025
• Device Model Number: SPSEB011E
• Device Catalogue Number: SPSEB011E
• Device Lot Number: 1702993
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/29/2018
• Initial Date Received by Manufacturer: 10/22/2018
• Supplement Date Received by Manufacturer: 01/15/2019
• Initial Report FDA Received Date: 11/14/2018
• Supplement Report FDA Received Date: 01/25/2019
• 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: 72 YR