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

Model Number KSP17100E

Device Problems Device Slipped (1584); Detachment of Device or Device Component (2907)

Patient Problems Failure of Implant (1924); Scar Tissue (2060); Joint Disorder (2373); No Information (3190); Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)

Event Date 12/06/2017

Event Type  Injury  

Manufacturer Narrative

The reported event was confirmed through the post operation notes.The device history records indicated that the released components met all specifications.The complaint history review indicated no trends among components or failure modes.Should additional information be obtained to further this investigation, the report will be updated.

Event Description

Patient with eleos revision hinge, heard a snapping/popping noise come from their knee while doing squats at physical therapy.A revision surgery was performed due to arthrofibrosis, failed total knee and morbid obesity, to remove excess scar tissue and perform a poly swap.Upon inspecting the joint, the surgeon noticed a free piece of cement and that the cemented resurfacing femur had loosened and dissociated from the stem extension.

Manufacturer Narrative

The medical device report (mdr) was initiated as part of a retrospective assessment of complaint 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 3013450937-2017-00001 for the other.The reported event was confirmed through the post operation notes.The device history records indicated that the released components met all specifications.The complaint history review indicated no trends among components or failure modes.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.This report was originally submitted on 13 september 2018.Fda reached out to onkos surgical on 24 august 2023 to alert onkos that this report was unable to be submitted as it was follow up #2.Onkos surgical has corrected the report to be follow up #1 and is re-submitting on 30 august 2023.

Event Description

Patient with eleos revision hinge, heard a snapping/popping noise come from their knee while doing squats at physical therapy.A revision surgery was performed due to arthrofibrosis, failed total knee and morbid obesity, to remove excess scar tissue and perform a poly swap.Upon inspection of the joint, the surgeon noticed a free piece of cement and that the cemented resurfacing femur had loosened, and the resurfacing femur and stem extension dissociated.

• Brand Name: ELEOS, STEM EXTENSION, CANAL FILLING, STRAIGHT
• Type of Device: PROSTHESIS, KNEE
• Manufacturer (Section D): ONKOS SURGICAL; 77 east halsey road; parsippany NJ 07054
• Manufacturer (Section G): MICROPORT ORTHOPEDIC; 5677 airline road; arlington TN 38002
• Manufacturer Contact: cristina butrico ; 77 east halsey road; parsippany, NJ 07054 ; 9732645433
• MDR Report Key: 7278343
• MDR Text Key: 100398452
• Report Number: 3013450937-2018-00002
• Device Sequence Number: 1
• Product Code: KRO
• UDI-Device Identifier: B278KSP17100E0
• UDI-Public: B278KSP17100E0
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K161520
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Company Representative
• Reporter Occupation: Other
• 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: 02/16/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: KSP17100E
• Device Catalogue Number: KSP17100E
• Device Lot Number: 1696594
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/08/2017
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 01/22/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/20/2017
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 57 YR
• Patient Sex: Male