MAUDE Adverse Event Report: ONKOS SURGICAL ELEOS, RESURFACING FEMUR, RIGHT; PROSTHESIS, KNEE

Model Number	2500R003E
Medical Device Problem Codes	Loss of Osseointegration (2408); Detachment of Device or Device Component (2907)
Health Effect - Clinical Codes	No Information (3190); No Code Available (3191)
Date of Event	12/06/2017
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
X-rays and other patient specific documentation was not provided for review.The device history record was reviewed and was found to be conforming.The implant was returned to allow for further investigation.
Event or Problem 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 to remove excess scar tissue and exchange the poly components for a thicker spacer.During surgery the surgeon noticed that the canal filling stem had dissociated from the intermedullary canal.The canal filling stem was removed and a cemented stem was implanted.
Additional 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 or Problem 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.
Additional Manufacturer Narrative
This medical device report (mdr) was initiated as part of a retrospective assessment of complaints under onkos surgical capa (b)(4).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 3013450937-2018-00002 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.
Event or Problem 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 the resurfacing femur and stem extension dissociated.

• Brand Name: ELEOS, RESURFACING FEMUR, RIGHT
• Common Device Name: PROSTHESIS, KNEE
• Manufacturer (Section D): ONKOS SURGICAL; 77 east halsey road; parsippany NJ 07054
• MDR Report Key: 7156567
• Report Number: 3013450937-2017-00001
• Device Sequence Number: 11017374
• Product Code: KRO
• UDI-Device Identifier: B278KSP17100E0
• UDI-Public: B278KSP17100E0
• 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: 2017
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,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: 05/04/2025
• Device Model Number: 2500R003E
• Device Catalogue Number: 2500R003E
• Device Lot Number: 1710617
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/08/2017
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 12/06/2017
• Supplement Date Received by Manufacturer: 01/22/2018; 01/22/2018
• Initial Report FDA Received Date: 01/02/2018
• Supplement Report FDA Received Date: 02/16/2018; 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: 57 YR