MAUDE Adverse Event Report: ONKOS SURGICAL ELEOS; CANAL FILLING STEM, 12X120MM, STRAIGHT, 28MM COLLAR

Model Number	FS-12120-03M
Medical Device Problem Codes	Loosening of Implant Not Related to Bone-Ingrowth (4002); Migration (4003)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	08/19/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device will not be returned for investigation as it was discarded after surgery.The investigation is in progress.When the investigation is complete, a supplemental report will be submitted accordingly.
Event or Problem Description
It was reported that the patient underwent a revision surgery on (b)(6) 2021 due to subsidence of the canal-filling segmental stem.The patient underwent their original eleos surgery on (b)(6) 2021 where the following devices were implanted: custom proximal tibia, tibial poly spacer, tibial hinge w.Rotational stop, distal femur axial pin, and canal-filling segmental stem.Post operation films showed a subsidence of the canal-filling segmental stem after several weeks.Dr.Cable revised the canal-filling segmental stem to an eleos modular cemented stem with a biogrip collar.The surgeon also revised the tibial poly spacer, tibial hinge, and distal femur axial pin.No additional information regarding this event has been provided.
Event or Problem Description
It was reported that the patient underwent a revision surgery on (b)(6) 2021 due to subsidence of the canal-filling segmental stem in the patient's tibia.The patient underwent their original eleos surgery on (b)(6) 2021 where the following devices were implanted: custom proximal tibia, tibial poly spacer, tibial hinge w.Rotational stop, distal femur axial pin, and canal-filling segmental stem.Post operation films showed a subsidence of the canal-filling segmental stem after several weeks.Dr.(b)(6) revised the canal-filling segmental stem to an eleos modular cemented stem with a biogrip collar.The surgeon also revised the tibial poly spacer, tibial hinge, and distal femur axial pin.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 patient undergoing a revision surgery due to the canal-filling segmental stem subsiding could not be determined.The device history records and sterilization batch records were reviewed and no issues during manufacturing or sterilization were identified that could have contributed to this complaint.The anatomical location of the implanted canal-filling segmental stem could have contributed to this adverse event since the bone canal widens towards the distal end of the tibia.If any additional information is obtained, a supplemental mdr will be filed accordingly.H3: device evaluated by manufacturer updated to no.H6: medical device problem code updated to 4002: loosening of implant not related to bone ingrowth.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 213: no device problem found.H6: investigation conclusions code updated to 4315: cause not established.

• Brand Name: ELEOS
• Common Device Name: CANAL FILLING STEM, 12X120MM, STRAIGHT, 28MM COLLAR
• 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 rd; parsippany, NJ 07054
• MDR Report Key: 12467499
• Report Number: 3013450937-2021-00201
• Device Sequence Number: 4891928
• Product Code: KRO
• UDI-Device Identifier: B278FS1212003M0
• UDI-Public: +B278FS1212003M0
• 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: 2021
• Device Explanted Year: 2021
• 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): 11/16/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: FS-12120-03M
• Device Catalogue Number: FS-12120-03M
• Device Lot Number: 85211
• 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: 08/19/2021
• Supplement Date Received by Manufacturer: 11/16/2021
• Initial Report FDA Received Date: 09/14/2021
• Supplement Report FDA Received Date: 11/16/2021
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 08/21/2019
• 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 25001212E, ELEOS TIBIAL POLY SPACER; P/N 25002111E, ELEOS DISTAL FEMUR AXIAL PIN; P/N CP4A0254, ELEOS CUSTOM PROXIMAL TIBIA; P/N THSMWRS01M, ELEOS TIBIAL HINGE; P/N 25001212E, ELEOS TIBIAL POLY SPACER; P/N 25002111E, ELEOS DISTAL FEMUR AXIAL PIN; P/N CP4A0254, ELEOS CUSTOM PROXIMAL TIBIA; P/N THSMWRS01M, ELEOS TIBIAL HINGE
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention
• Patient Age: 31 YR
• Patient Sex: Male