MAUDE Adverse Event Report: ONKOS SURGICAL ELEOS; ELEOS TIBIAL POLY SPACER 8MM

Model Number	25001208E
Medical Device Problem Codes	Adverse Event Without Identified Device or Use Problem (2993); Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	01/04/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that the patient scheduled a revision surgery on (b)(6) 2022 for a poly swap after having a distal femoral replacement surgery on (b)(6) 2021.The revision surgery was cancelled and has not been rescheduled.It was cancelled due to alleged patient illness.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: 3013450937-2022-000031, 3013450937-2022-000032, 3013450937-2022-000033, 3013450937-2022-000034, 3013450937-2022-000035, 3013450937-2022-000036 and 3013450937-2022-000037.
Event or Problem Description
It was reported that the patient scheduled a revision surgery on (b)(6) 2022 for a poly swap after having a distal femoral replacement surgery on (b)(6) 2021.The revision surgery was cancelled and has not been rescheduled.It was cancelled due to alleged patient illness.No additional information regarding this adverse event has been provided.This record captures the eleos poly spacer.
Additional Manufacturer Narrative
It was reported on (b)(6) 2022 that a patient was scheduled to undergo a revision procedure to replace the eleos poly spacer component.The patient's primary surgery date was (b)(6) 2021.The following implants remain implanted in the patient: distal femur, distal femur axial pin, cemented stem, cemented stem extension, male-female midsection, tibial baseplate, tibial hinge, and tibial poly spacer.The revision procedure was cancelled due to alleged patient illness.Patient's medical and previous surgical history was not available for review.Details regarding patient compliance, activity levels, and trauma were unknown as well.A review of the work orders and sterilization batch release records for the products involved found no indication that the adverse event was a result of a manufacturing or sterilization nonconformance.As additional information regarding the alleged patient illness was not provided, a root cause could not be determined conclusively and it cannot be established whether an onkos device caused or contributed to the event.

• Brand Name: ELEOS
• Common Device Name: ELEOS TIBIAL POLY SPACER 8MM
• Manufacturer (Section D): ONKOS SURGICAL; 77 east halsey road; parsippany NJ 07054
• Manufacturer (Section G): MICROPORT ORTHOPEDICS INC; 5677 airline road; arlington TN 38002
• Manufacturer Contact: upasana basnet ; 77 east halsey road; parsippany, NJ 07054 ; 8447672766
• MDR Report Key: 13447635
• Report Number: 3013450937-2022-00038
• Device Sequence Number: 20108880
• Product Code: KRO
• UDI-Device Identifier: B27825001070E0
• UDI-Public: B27825001070E0
• Combination Product (Y/N): N
• Initial Reporter State: NC
• Initial Reporter Country: US
• PMA/510(K) Number: K161520
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2021
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 04/04/2022

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 Expiration Date: 10/28/2020
• Device Model Number: 25001208E
• Device Catalogue Number: 25001208E
• Device Lot Number: 1856898
• 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: 01/04/2022
• Supplement Date Received by Manufacturer: 01/04/2022
• Initial Report FDA Received Date: 02/03/2022
• Supplement Report FDA Received Date: 04/04/2022
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 10/28/2020
• 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: 1841268 ELEOS STEM EXTENSION, CEMENTED.; 1841268 ELEOS STEM EXTENSION, CEMENTED.; 25000009E ELEOS DISTAL FEMUR.; 25000009E ELEOS DISTAL FEMUR.; 25001070E ELEOS MALE-FEMALE MIDSECTION.; 25001070E ELEOS MALE-FEMALEMIDSECTION.; 25002111E ELEOS DISTAL FEMUR AXIAL PIN.; 25002111E ELEOS DISTAL FEMUR AXIAL PIN.; 25002203E ELEOS TIBIAL BASEPLATE.; 25002203E ELEOS TIBIAL BASEPLATE.; CS-17120-03M ELEOS CEMENTED STEM.; CS-17120-03M ELEOS CEMENTED STEM.; THSMWRS01M ELEOS TIBIAL HINGE W/ ROTATIONAL STOP.; THSMWRS01M ELEOS TIBIAL HINGE W/ ROTATIONAL STOP.
• Patient Age: 82 YR
• Patient Sex: Unknown