MAUDE Adverse Event Report: ONKOS SURGICAL ELEOS; SIZE 2: TIBIAL BASEPLATE

Model Number	TB-2202E-01M
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	11/21/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that a patient had an alleged infection and underwent a revision surgery on (b)(6) 2022.The following implants were revised during the revision: eleos distal femur axial pin, eleos tibial hinge w/ rotational stop and eleos tibial poly spacer.
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: 3013450937-2022-00391, 3013450937-2022-00392, 3013450937-2022-00393, 3013450937-2022-00394, 3013450937-2022-00395, 3013450937-2022-00396, 3013450937-2022-00398 and 3013450937-2022-00399.
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: type of investigation code updated to 3331: analysis of production records h6: type of investigation code updated to 4111: communication/interviews h6: type of investigation code updated to 4109: historical data analysis h6: investigation findings code updated to 3221: no findings available h6: investigation conclusions code updated to 4315: cause not established h10: additional narratives/data.
Event or Problem Description
It was reported that a patient had an alleged infection and underwent a revision surgery on(b)(6) 2022.The following implants were revised during the revision: eleos distal femur axial pin, eleos tibial hinge w/ rotational stop and eleos tibial poly spacer.

• Brand Name: ELEOS
• Common Device Name: SIZE 2: TIBIAL BASEPLATE
• 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: 16028338
• Report Number: 3013450937-2022-00397
• Device Sequence Number: 5450062
• Product Code: KRO
• UDI-Device Identifier: B278TB2202E01M0
• UDI-Public: B278TB2202E01M0
• Combination Product (Y/N): N
• Initial Reporter State: NY
• Initial Reporter Country: US
• PMA/510(K) Number: K161520
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted 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): 03/17/2023

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: TB-2202E-01M
• Device Catalogue Number: TB-2202E-01M
• Device Lot Number: 93643-001
• 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: 11/21/2022
• Supplement Date Received by Manufacturer: 02/17/2023
• Initial Report FDA Received Date: 12/21/2022
• Supplement Report FDA Received Date: 03/17/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 07/15/2022
• 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: 25000007E ELEOS DISTAL FEMUR, LEFT, SEGMENTAL; 25001090E ELEOS MALE-FEMALE MIDSECTION, SIZE: 90MM; 25001212E ELEOS TIBIAL POLY SPACER, THICKNESS:12MM; 25002111E ELEOS DISTAL FEMUR AXIAL PIN; FS-11120-03M ELEOS CANAL FILLING STEM; KSP12100E ELEOS CANAL FILLING STEM EXTENSION; TB-TSCRW-01M ELEOS TIBIAL BASEPLATE TAPERED SCREW; THSMWRS01M ELEOS TIBIAL HINGE W/ ROTATIONAL STOP
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention
• Patient Age: 64 YR
• Patient Sex: Female