MAUDE Adverse Event Report: ONKOS SURGICAL ELEOS; TIBIAL POLY SPACER, 10MM

Model Number	25001210E
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Loss of Range of Motion (2032); Scar Tissue (2060)
Date of Event	10/06/2022
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.Multiple mdrs were submitted for this event: #3013450937-2022-00305 #3013450937-2022-00306, #3013450937-2022-00308, #3013450937-2022-00309, #3013450937-2022-00310, #3013450937-2022-00311, #3013450937-2022-00312, #3013450937-2022-00313, #3013450937-2022-00314.
Event or Problem Description
It was reported that the patient was experiencing loss of mobility in their knee.The patient underwent a revision surgery on (b)(6) 2022.During the revision surgery, the surgeon identified scar tissue formation.The surgeon removed the scar tissue.The surgeon took out all of the implants besides the segmental stem, collar, locking ring, and tibial baseplate, and flashed these devices then re-implanted the devices.The surgeon scheduled another revision surgery on (b)(6) 2022 in order to revise some implants and perform a washout in order to prevent an infection.On (b)(6) 2022, the surgeon revised the following implants: distal femur axial pin, poly spacer, tibial hinge component, distal femur, and male-female midsection.No additional information regarding this 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 adverse event could not be determined.The device history records and sterilization batch records were reviewed and no issues during manufacturing or sterilization were identified that would have contributed to this complaint.If any additional information is obtained, a supplemental mdr will be filed accordingly.The following sections were updated: 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 4111: communication/interviews h6: type of investigation code updated to 4110: trend analysis.H6: type of investigation code updated to 4114: device not returned.H6: type of investigation code updated to 4117: device not accessible for testing.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.
Event or Problem Description
It was reported that the patient was experiencing loss of mobility in their knee.The patient underwent a revision surgery on (b)(6) 2022.During the revision surgery, the surgeon identified scar tissue formation.The surgeon removed the scar tissue.The surgeon took out all of the implants besides the segmental stem, collar, locking ring, and tibial baseplate, and flashed these devices then re-implanted the devices.The surgeon scheduled another revision surgery on (b)(6) 2022 in order to revise some implants and perform a washout in order to prevent an infection.On (b)(6) 2022, the surgeon revised the following implants: distal femur axial pin, poly spacer, tibial hinge component, distal femur, and male-female midsection.No additional information regarding this event has been provided.

• Brand Name: ELEOS
• Common Device Name: TIBIAL POLY SPACER, 10MM
• Manufacturer (Section D): ONKOS SURGICAL; 77 east halsey road; parsippany NJ 07054
• Manufacturer (Section G): MICROPORT ORTHOPEDICS; 5677 airline road; arlington TN 38002
• Manufacturer Contact: sara dailey ; 77 east halsey road; parsippany, NJ 07054
• MDR Report Key: 15677479
• Report Number: 3013450937-2022-00307
• Device Sequence Number: 20413366
• Product Code: KRO
• UDI-Device Identifier: B27825001210E0
• UDI-Public: B27825001210E0
• Combination Product (Y/N): N
• Initial Reporter State: OH
• Initial Reporter Country: US
• PMA/510(K) Number: K203815
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2021
• 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): 12/27/2022

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: 25001210E
• Device Catalogue Number: 25001210E
• Device Lot Number: 1813665
• 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: 09/26/2022
• Supplement Date Received by Manufacturer: 12/22/2022
• Initial Report FDA Received Date: 10/26/2022
• Supplement Report FDA Received Date: 12/27/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 08/28/2019
• 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 25001140E, ELEOS MALE FEMALE MIDSECTION; P/N 25002111E, ELEOS DISTAL FEMUR AXIAL PIN; P/N HC-15120-03M, ELEOS CEMENTED SEGMENTAL STEM; P/N HR-30000-03M, ELEOS COLLAR LOCKING RING; P/N KPONTP32E, ELEOS RESURFACING PATELLA; P/N PB-3200R-03M, ELEOS BIOGRIP HA COLLAR; P/N TB-2203E-01M, ELEOS TIBIAL BASEPLATE; P/N THSMWRS01M, ELEOS TIBIAL HINGE COMPONENT
• Outcome Attributed to Adverse Event: Hospitalization
• Patient Age: 70 YR
• Patient Sex: Female