MAUDE Adverse Event Report: ONKOS SURGICAL ELEOS; TIBIAL POLY SPACER, 20MM

Model Number	25001220E
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Pain (1994)
Date of Event	08/17/2023
Type of Reportable Event	Serious Injury
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.
Event or Problem Description
It was reported that the patient underwent a revision surgery on (b)(6) 2023 due to patella pain.During the revision surgery, the surgeon revised the distal femur axial pin, poly spacer, and non-onkos tibial hinge component.The surgeon wanted to lower the patient's joint line, therefore, they revised the 20mm tibial poly spacer to an 8mm tibial poly spacer.There were no alleged malfunctions of the distal femur axial pin and non-onkos tibial hinge component.No additional information regarding this adverse event has been reported.
Additional Manufacturer Narrative
It was reported that the patient underwent a revision surgery on (b)(6) 2023 due to patella pain.During the revision surgery, the surgeon revised the distal femur axial pin, poly spacer, and non-onkos tibial hinge component.The surgeon wanted to lower the patient's joint line, therefore, they revised the 20mm tibial poly spacer to an 8mm tibial poly spacer.There were no alleged malfunctions of the distal femur axial pin and non-onkos tibial hinge component.The following implants remain implanted from the patient's original surgery: distal femur, biogrip ha collar, collar locking ring, segmental stem, tibial baseplate, and stem extension.The root cause of the patella pain could not be determined conclusively.Patella pain could be caused by patient's patella lying lower than intended, which can cause pain and restricted range of motion.The cause of this condition could have been due to multiple factors- insufficient alignmentplacement of the patella intra-operatively, improper selection or positioning of components intra-operatively, post-operative trauma, etc.The cause of patella pain could have been due to multiple factors - joint damage, osteoarthritis, injury, infection, etc.The device history record and sterilization batch record for the lots involved in this complaint were reviewed, and no issues were identified related to the design, manufacturing and/or sterilization of the device.

• Brand Name: ELEOS
• Common Device Name: TIBIAL POLY SPACER, 20MM
• 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: vandita patel ; 77 east halsey road; parsippany, NJ 07054 ; 8447672766
• MDR Report Key: 17760700
• Report Number: 3013450937-2023-00207
• Device Sequence Number: 6768005
• Product Code: KRO
• UDI-Device Identifier: B27825001220E0
• UDI-Public: B27825001220E0
• Combination Product (Y/N): N
• Initial Reporter State: LA
• Initial Reporter Country: US
• PMA/510(K) Number: K161520
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2022
• 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): 09/15/2023

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: 25001220E
• Device Catalogue Number: 25001220E
• Device Lot Number: 1856899
• 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: 08/17/2023
• Supplement Date Received by Manufacturer: 10/17/2023
• Initial Report FDA Received Date: 09/15/2023
• Supplement Report FDA Received Date: 12/15/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 09/11/2020
• 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 25002111E, ELEOS DISTAL FEMUR AXIAL PIN; P/N HC-13120-03M, ELEOS SEGMENTAL STEM; P/N HR-30001-03M, ELEOS COLLAR LOCKING RING; P/N KSC12100E, ELEOS STEM EXTENSION; P/N PB-3600R-03M, ELEOS BIOGRIP COLLAR; P/N TB-2204E-01M, ELEOS TIBIAL BASEPLATE
• Outcome Attributed to Adverse Event: Hospitalization
• Patient Age: 76 YR
• Patient Sex: Male