MAUDE Adverse Event Report: ONKOS SURGICAL ELEOS; PROXIMAL TIBIA 87MM

Model Number	PT-20000-02M
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Unspecified Infection (1930); Insufficient Information (4580)
Date of Event	01/25/2022
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: 3013450937-2022-00106, 3013450937-2022-00107, 3013450937-2022-00108 and 3013450937-2022-00109.The following mdr was also submitted for this patient: 3013450937-2022-00030.
Event or Problem Description
Patient was revised on (b)(4) 2022 for an alleged infection.During this revision surgery the following implants were explanted: eleos proximal tibia 87mm, eleos male-female midsection 50mm, eleos tibial poly spacer 8mm, and eleos tibial hinge component w/ rotational stop.During this revision surgery the following implants were implanted: eleos proximal tibia 87mm, eleos male-female midsection 50mm, eleos tibial poly spacer 8mm, and eleos tibial hinge component w/ rotational stop.After this revision surgery the following implants remain implanted: eleos resurfacing femur axial pin size 2.No additional information regarding this adverse event has been provided.
Event or Problem Description
Patient was revised on (b)(6) 2022 for an alleged infection.During this revision surgery the following implants were explanted: eleos proximal tibia 87mm, eleos male-female midsection 50mm, eleos tibial poly spacer 8mm, and eleos tibial hinge component w/ rotational stop.During this revision surgery the following implants were implanted: eleos proximal tibia 87mm, eleos male-female midsection 50mm, eleos tibial poly spacer 8mm, and eleos tibial hinge component w/ rotational stop.After this revision surgery the following implants remain implanted: eleos resurfacing femur axial pin size 2.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 infection 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.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 4110: trend analysis.H6: type of investigation code updated to 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: PROXIMAL TIBIA 87MM
• Manufacturer (Section D): ONKOS SURGICAL; 77 east halsey road; parsippany NJ 07054
• Manufacturer (Section G): PHILLIPS PRECISION INC.; 7 paul kohner place; elmwood park NJ 07407
• Manufacturer Contact: danielle pierce ; 77 east halsey road; parsippany 07054 ; 8447672766
• MDR Report Key: 13586307
• Report Number: 3013450937-2022-00105
• Device Sequence Number: 20218780
• Product Code: KRO
• UDI-Device Identifier: B278PT2000002M0
• UDI-Public: B278PT2000002M0
• Combination Product (Y/N): N
• Initial Reporter State: NY
• Initial Reporter Country: US
• PMA/510(K) Number: K203090
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2022
• Device Explanted Year: 2022
• 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): 04/24/2022

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: PT-20000-02M
• Device Catalogue Number: PT-20000-02M
• Device Lot Number: 88658RR-031
• 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: 01/24/2022
• Supplement Date Received by Manufacturer: 04/24/2022
• Initial Report FDA Received Date: 02/23/2022
• Supplement Report FDA Received Date: 04/24/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 04/05/2021
• 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: 25001050E ELEOS MALE-FEMALE MIDSECTION 50MM.; 25001208E ELEOS TIBIAL POLY SPACER 8MM.; 25002100E ELEOS TIBIAL HINGE COMPONENT.; 25002112E ELEOS RESURFACING FEMUR AXIAL PIN SIZE 2.
• Outcome Attributed to Adverse Event: Required Intervention; Hospitalization
• Patient Age: 16 YR
• Patient Sex: Male