MAUDE Adverse Event Report: ONKOS SURGICAL ELEOS; SEGMENTAL STEM, CANAL FILLING, 21X120MM STRAIGHT SPLINED FULL PLASMA 36MMCOLLAR

Model Number	FS-21120-03M
Medical Device Problem Code	Loosening of Implant Not Related to Bone-Ingrowth (4002)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	09/17/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The device will not be returned for investigation as it was discarded at the hospital.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 loosening of the pressfit segmental stem.Several months after the patient's original eleos surgery, the patient presented with a loose stem that was confirmed radiographically.During the revision surgery, the surgeon revised the segmental stem, distal femur, male-female midsection, distal femur axial pin, tibial hinge component, and tibial poly spacer.No further information regarding this event was made available.
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.If any additional information is obtained, a supplemental mdr will be filed accordingly.The following sections were updated: b4: date of this report added.B7: other relevant history 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: 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.H10: additional narratives/data.
Event or Problem Description
It was reported that the patient underwent a revision surgery on (b)(6) 2021 due to loosening of the pressfit segmental stem.Several months after the patient's original eleos surgery, the patient presented with a loose stem that was confirmed radiographically.During the revision surgery, the surgeon revised the segmental stem, distal femur, male-female midsection, distal femur axial pin, tibial hinge component, and tibial poly spacer.No further information regarding this event was made available.

• Brand Name: ELEOS
• Common Device Name: SEGMENTAL STEM, CANAL FILLING, 21X120MM STRAIGHT SPLINED FULL PLASMA 36MMCOLLAR
• 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
• MDR Report Key: 12537674
• Report Number: 3013450937-2021-00222
• Device Sequence Number: 11047922
• Product Code: KRO
• UDI-Device Identifier: B278FS2112003M0
• UDI-Public: +B278FS2112003M0
• 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): 11/29/2021

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?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 01/18/2024
• Device Model Number: FS-21120-03M
• Device Catalogue Number: FS-21120-03M
• Device Lot Number: 81701
• 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: 09/02/2021
• Supplement Date Received by Manufacturer: 11/29/2021
• Initial Report FDA Received Date: 09/27/2021
• Supplement Report FDA Received Date: 11/29/2021
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 01/18/2016
• 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 25000009E, ELEOS DISTAL FEMUR; P/N 25001040E, ELEOS MALE-FEMALE MIDSECTION; P/N 25001212E, ELEOS TIBIAL POLY SPACER; P/N 25002100E, ELEOS TIBIAL HINGE COMPONENT; P/N 25002111E, ELEOS DISTAL FEMUR AXIAL PIN; P/N 25002203E, ELEOS TIBIAL BASEPLATE; P/N KSC01665E, ELEOS STEM EXTENSION, CEMENTED
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention
• Patient Age: 69 YR
• Patient Sex: Female