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

Model Number KSC18100E

Device Problems Detachment Of Device Component (1104); Detachment of Device or Device Component (2907)

Patient Problems Unspecified Infection (1930); Patient Problem/Medical Problem (2688)

Event Date 05/17/2018

Event Type  Injury  

Manufacturer Narrative

This report is for one of two devices involved in the event, please refer to report 3013450937-2018-00009 for the other.The device history records and sterilization batch release records were reviewed and indicated that all components involved met specification.The operation notes have been requested along with the explanted components.It was relayed that the components whereabouts are unknown and will not be returned.This investigation is currently ongoing and should additional information be obtained the report will be supplemented.

Event Description

Revision surgery performed on eleos resurfacing hinge knee where it appeared on x-rays that the resurfacing femur and stem extension had dissociated.Upon removal of the components it was discovered that the resurfacing femur had also loosened.

Manufacturer Narrative

This medical device report (mdr) was initiated as part of a retrospective assessment of complaints under onkos surgical capa 18-007.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 3013450937-2018-00009 for the other.The device history records and sterilization batch release records were reviewed and indicated that all components involved met specification.The operation notes have been requested along with the explanted components.It was relayed that the components whereabouts are unknown and will not be returned.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 Description

Revision surgery performed on eleos resurfacing hinge knee where it appeared on x-rays that the resurfacing femur and stem extension had dissociated.Upon removal of the components it was discovered that the resurfacing femur had also loosened.

• Brand Name: ELEOS, STEM EXTENSION, CEMENTED, STRAIGHT
• Type of Device: PROSTHESIS, STEM
• Manufacturer (Section D): ONKOS SURGICAL; 77 east halsey road; parsippany NJ 07054
• MDR Report Key: 7582361
• MDR Text Key: 110481321
• Report Number: 3013450937-2018-00008
• Device Sequence Number: 1
• Product Code: KRO
• UDI-Device Identifier: B278KSC18100E0
• UDI-Public: B278KSC18100E0
• Combination Product (y/n): N
• PMA/PMN Number: K161520
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor
• Type of Report: Initial,Followup
• Report Date: 09/13/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/08/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: KSC18100E
• Device Catalogue Number: KSC18100E
• Device Lot Number: 1704385
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 05/17/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 63 YR