MAUDE Adverse Event Report: ONKOS SURGICAL ELEOS TIBIAL POLY SPACER; PROSTHESIS, KNEE

Model Number 25001212E

Device Problem Device Damaged by Another Device (2915)

Patient Problems Pain (1994); No Information (3190)

Event Date 08/08/2019

Event Type  Injury  

Manufacturer Narrative

This report is for one of two devices involved in this event, please refer to report 3013450937-2019-00048.The device history record and sterilization batch release record were reviewed and indicated that the component met specification.The tibial poly spacer was returned for further analysis and this report will be supplemented when further information is made available.

Event Description

Patient x-rays revealed that the post of the tibial hinge component had fractured and required surgical intervention.During the revision surgery, the tibial poly spacer was identified as being damaged and was revised.

Manufacturer Narrative

This report is for one of two devices involved in this event, please refer to report 3013450937-2019-00048.The device history record and sterilization batch release record were reviewed and indicated that the component met specification.The tibial poly spacer was returned extremely damaged and the fractured tibial hinge component stem was lodged within the tibial poly spacer stem.The tibial poly spacer stem was deformed approximately an inch from the upper edge, posteriorly to anteriorly.The deformation shows that the upper part of the tibial poly spacer stem and hinge stem were not within the tibial baseplate during this failure.Additionally, the lateral side of the face of the tibial poly spacer was deformed indicating that the patient's knee was not tracking evenly on the spacer.A dimensional analysis was unable to be performed on the tibial poly spacer due to the amount of deformation.The tibial poly spacer becoming deformed could have been a result of the tibial hinge component fracturing.Ultimately, the root cause of the complaint was unable to be determined, but based upon the device history record, sterilization record, returned component, and patient history it was concluded that the malfunction could not be attributed to the manufacturing of the eleos component or a nonconformance.

Event Description

Patient presented with knee pain and x-rays revealed that the post of the tibial hinge component had fractured and required surgical intervention.During the revision surgery, the tibial poly spacer was identified as being damaged and was revised.

• Brand Name: ELEOS TIBIAL POLY SPACER
• Type of Device: PROSTHESIS, KNEE
• Manufacturer (Section D): ONKOS SURGICAL; 77 east halsey road; parsippany NJ 07054
• MDR Report Key: 9072571
• MDR Text Key: 160615391
• Report Number: 3013450937-2019-00055
• Device Sequence Number: 1
• Product Code: KRO
• UDI-Device Identifier: B27825001212E0
• UDI-Public: B27825001212E0
• Combination Product (y/n): N
• PMA/PMN Number: K161520
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Type of Report: Initial,Followup
• Report Date: 10/21/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/16/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 25001212E
• Device Catalogue Number: 25001212E
• Device Lot Number: 1699710
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/09/2019
• Date Manufacturer Received: 10/10/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 61 YR