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	Joint Laxity (4526)
Date of Event	04/05/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that the patient underwent a revision surgery on (b)(6) 2023 due to soft tissue laxity.During the revision surgery, the surgeon revised the distal femur axial pin, poly spacer, and tibial hinge component.The 16mm poly spacer was revised to a 20mm poly spacer.No additional information regarding this adverse event has been reported.
Additional Manufacturer Narrative
The investigation is in process.The device will not be returned for evaluation.When the investigation is complete, a supplemental mdr will be submitted accordingly.Multiple mdrs were submitted for this event: #3013450937-2023-00060, #3013450937-2023-00061.The following mdrs were submitted for the same patient: #3013450937-2021-00270, #3013450937-2021-00271, #3013450937-2021-00272, #3013450937-2021-00273, #3013450937-2021-00274, #3013450937-2021-00275, #3013450937-2021-00276, #3013450937-2021-00277, #3013450937-2021-00278, #3013450937-2021-00279.
Additional Manufacturer Narrative
This report is being submitted to include additional information.The investigation is complete.The device was not returned for evaluation.The device history records and sterilization batch records were reviewed and there were no non-conformances identified that would have contributed to this adverse event.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 3331: analysis of production records h6: type of investigation code updated to 4109: historical data analysis h6: type of investigation code updated to 4110: trend analysis h6: type of investigation code updated to 4114: device not returned 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 the patient underwent a revision surgery on (b)(6) 2023 due to soft tissue laxity.During the revision surgery, the surgeon revised the distal femur axial pin, poly spacer, and tibial hinge component.The 16mm poly spacer was revised to a 20mm poly spacer.No additional information regarding this adverse event has been reported.

• 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 rd; arlington TN 38002
• Manufacturer Contact: sara dailey ; 77 east halsey road; parsippany, NJ 07054 ; 8447672766
• MDR Report Key: 16843961
• Report Number: 3013450937-2023-00062
• Device Sequence Number: 6870438
• Product Code: KRO
• UDI-Device Identifier: B27825001216E0
• UDI-Public: B27825001216E0
• Combination Product (Y/N): N
• Initial Reporter State: CO
• 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: 2023
• 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): 06/20/2023

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: 25001216E
• Device Catalogue Number: 25001216E
• Device Lot Number: 1856900
• 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: 04/04/2023
• Supplement Date Received by Manufacturer: 06/20/2023
• Initial Report FDA Received Date: 05/01/2023
• Supplement Report FDA Received Date: 06/20/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 09/29/2020
• 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 25000007E, ELEOS DISTAL FEMUR.; P/N 25001040E, ELEOS MALE FEMALE MIDSECTION.; P/N 25002111E, ELEOS DISTAL FEMUR AXIAL PIN.; P/N 25002203E, ELEOS TIBIAL BASEPLATE.; P/N 2500BP22E, ELEOS SEGMENTAL STEM.; P/N KSP18140E, ELEOS STEM EXTENSION.; P/N KTAGB305E, ELEOS TIBIAL BLOCK AUGMENT.; P/N KTAGB315E, ELEOS TIBIAL BLOCK AUGMENT.; P/N THSMWRS01M, ELEOS TIBIAL HINGE COMPONENT.
• Outcome Attributed to Adverse Event: Hospitalization
• Patient Age: 67 YR
• Patient Sex: Male