MAUDE Adverse Event Report: ONKOS SURGICAL ELEOS; TIBIAL POLY SPACER - 16MM

Model Number	25001216E
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	12/17/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The investigation is in progress.When it is complete a supplemental mdr will be submitted accordingly.Multiple mdrs were submitted for this adverse event: 3013450937-2022-00004 and 3013450937-2022-00005.
Event or Problem Description
It was reported that the patient's margins in soft tissue were not clear when pathology came back post-op and therefore a revision surgery was performed to extend the resection of soft tissue and replace easily replaceable components.During the revision surgery the following implants were revised: eleos resurfacing femur axial pin size 3, eleos tibial hinge with rotational stop, and eleos tibial poly spacer 16mm.No additional information regarding this adverse event has been provided.
Additional Manufacturer Narrative
The investigation is in progress.When it is complete a supplemental mdr will be submitted accordingly.Multiple mdrs were submitted for this adverse event: 3013450937-2022-00004 and 3013450937-2022-00005.
Event or Problem Description
It was reported that the patient's margins in soft tissue were not clear when pathology came back post-op and therefore a revision surgery was performed to extend the resection of soft tissue and replace easily replaceable components.During the revision surgery the following implants were revised: eleos resurfacing femur axial pin size 3, eleos tibial hinge with rotational stop, and eleos tibial poly spacer 16mm.No additional information regarding this adverse event has been provided.
Event or Problem Description
It was reported that the patient's margins in soft tissue were not clear when pathology came back post-op and therefore a revision surgery was performed to extend the resection of soft tissue and replace easily replaceable components.During the revision surgery the following implants were revised: eleos resurfacing femur axial pin size 3, eleos tibial hinge with rotational stop, and eleos tibial poly spacer 16mm.No additional information regarding this adverse event has been provided.
Additional Manufacturer Narrative
This report is being submitted to include additional information.The investigation is complete.The device was not returned for evaluation.The root cause of the alleged implant loosening could not be determined.If any additional information is obtained, a supplemental mdr will be filed accordingly.The following sections were updated: b4: date of this report added.D9.Device available for evaluation updated to no.G3: date received by manufacturer added.G6: type of report added.H2: follow-up type added.H3: device evaluated by manufacturer updated to no.H6: type of investigation code updated to add 4110: trend analysis.H6: type of investigation code updated to add 4117: device not accessible for testing.H6: investigation findings code updated to 3221: no findings available.H6: investigation conclusions code updated to 4315: cause not established.H10: additional narratives/data.

• Brand Name: ELEOS
• Common Device Name: TIBIAL POLY SPACER - 16MM
• Manufacturer (Section D): ONKOS SURGICAL; 77 east halsey road; parsippany NJ 07054
• Manufacturer (Section G): MICROPORT ORTHOPEDICS; 5677 airline road; arlington TN 38002
• Manufacturer Contact: danielle pierce ; 77 east halsey road; parsippany 07054 ; 8447672766
• MDR Report Key: 13261709
• Report Number: 3013450937-2022-00006
• Device Sequence Number: 1701760
• Product Code: KRO
• UDI-Device Identifier: B27825001216E0
• UDI-Public: B27825001216E0
• Combination Product (Y/N): N
• Initial Reporter State: PA
• Initial Reporter Country: US
• PMA/510(K) Number: K161520
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2021
• Device Explanted Year: 2021
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 03/16/2022

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 Model Number: 25001216E
• Device Catalogue Number: 25001216E
• Device Lot Number: 1785592
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/16/2021
• Supplement Date Received by Manufacturer: 03/16/2022
• Initial Report FDA Received Date: 01/14/2022
• Supplement Report FDA Received Date: 03/17/2022
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 03/11/2019
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: P/N 25002113E RESURFACING FEMUR AXIAL PIN SIZE 3; P/N 2500L003E ELEOS RESURFACING FEMUR SIZE 3; P/N FS-12120-03M ELEOS CANAL FILLING; P/N PT-20000-02M ELEOS PROXIMAL TIBIA; P/N THSMWRS01MELEOS TIBIAL HINGE COMPONENT; P/N: KSP20100E ELEOS STEM EXTENSION CANAL FILLING
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention
• Patient Sex: Unknown