MAUDE Adverse Event Report: ONKOS SURGICAL ELEOS; CANAL-FILLING STRAIGHT SEGMENTAL STEM, 17X120MM, SPLINED, FULL PLASMA

Model Number	FS-17120-03M
Medical Device Problem Code	Loosening of Implant Not Related to Bone-Ingrowth (4002)
Health Effect - Clinical Code	Joint Dislocation (2374)
Date of Event	04/11/2023
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.Multiple mdrs have been submitted for this event: 3013450937-2023-00073.
Event or Problem Description
It was reported that the patient underwent a revision surgery on (b)(6) 2023 due to patella dislocation.During the revision surgery it was identified that the femoral segmental stem had loosened and subsided.The surgeon revised the 17x120mm canal-filling segmental stem to a 15x120mm cemented modular collar segmental stem.During the revision surgery, the surgeon additionally revised the following eleos devices: distal femur, tibial hinge component, poly spacer, male-female midsection, and distal femur axial pin.There were no alleged malfunctions of the distal femur, tibial hinge component, poly spacer, male-female midsection, and distal femur axial pin.No additional information regarding this adverse event has been reported.
Event or Problem Description
It was reported that the patient underwent a revision surgery on (b)(6) 2023 due to patella dislocation.During the revision surgery it was identified that the femoral segmental stem had loosened and subsided.The surgeon revised the 17x120mm canal-filling segmental stem to a 15x120mm cemented modular collar segmental stem.During the revision surgery, the surgeon additionally revised the following eleos devices: distal femur, tibial hinge component, poly spacer, male-female midsection, and distal femur axial pin.There were no alleged malfunctions of the distal femur, tibial hinge component, poly spacer, male-female midsection, and distal femur axial pin.No additional information regarding this adverse event has been reported.
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.

• Brand Name: ELEOS
• Common Device Name: CANAL-FILLING STRAIGHT SEGMENTAL STEM, 17X120MM, SPLINED, FULL PLASMA
• Manufacturer (Section D): ONKOS SURGICAL; 77 east halsey road; parsippany NJ 07054
• Manufacturer (Section G): PHILLIPS PRECISION INC; 7 paul kohner pl; elmwood park NJ 07407
• Manufacturer Contact: sara dailey ; 77 east halsey road; parsippany, NJ 07054 ; 8447672766
• MDR Report Key: 16911092
• Report Number: 3013450937-2023-00072
• Device Sequence Number: 14956877
• Product Code: KRO
• UDI-Device Identifier: B278FS1712003M0
• UDI-Public: B278FS1712003M0
• Combination Product (Y/N): N
• Initial Reporter State: MD
• 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): 07/07/2023

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: FS-17120-03M
• Device Catalogue Number: FS-17120-03M
• Device Lot Number: 90740-019
• 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: 04/11/2023
• Supplement Date Received by Manufacturer: 07/07/2023
• Initial Report FDA Received Date: 05/11/2023
• Supplement Report FDA Received Date: 07/07/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 11/16/2021
• 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 25001050E, ELEOS MALE FEMALE MIDSECTION; P/N 25001208E, ELEOS POLY SPACER; P/N 25002111E, ELEOS DISTAL FEMUR AXIAL PIN; P/N KPONTP35E, ELEOS RESURFACING PATELLA; P/N KSC01530E, ELEOS STEM EXTENSION; P/N TB-2204E-01M, ELEOS TIBIAL BASEPLATE; P/N THSMWRS01M, ELEOS TIBIAL HINGE COMPONENT
• Outcome Attributed to Adverse Event: Hospitalization
• Patient Age: 71 YR
• Patient Sex: Male
• Patient Race: White