MAUDE Adverse Event Report: ONKOS SURGICAL ELEOS; CANAL FILLING STEM, 13MMX120MM, STRAIGHT, SPLINED, FULL PLASMA, 28MM COLLAR

Model Number	FS-13120-03M
Medical Device Problem Code	Loosening of Implant Not Related to Bone-Ingrowth (4002)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	01/20/2022
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The investigation is in progress.When it is complete a supplemental mdr will be submitted accordingly.
Event or Problem Description
Patient was revised on (b)(6) 2022 for an alleged femoral stem loosening.During this revision surgery the following was explanted: eleos distal femur left segmental, eleos male-female midsection 60mm, eleos canal filling stem 13mmx120mm straight splined full plasma 28mm collar, eleos tibial baseplate size 3, eleos stem extension canal filling 13mmx140mm straight splined slotted, eleos tibial poly spacer 8mm, eleos hinge w/ rotational stop, and eleos distal femur axial pin.During this revision surgery the following implants were implanted: eleos distal femur left segmental, male-female midsection 40mm, eleos porous ha treated round 34mm 32mm modular porous biogrip ha collar, eleos cemented stem 15mmx120mm straight fluted, eleos modular collar locking ring and impactor tip, eleos tibial poly spacer 8mm, eleos tibial hinge w/ rotational stop, and eleos distal femur axial pin.No additional information regarding this adverse 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 canal-filling segmental stem loosening could not be determined.If any additional information is obtained, a supplemental mdr will be filed accordingly.The following sections were updated: b5: correction to adverse event or product problem 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 4110: trend analysis.H6: type of investigation code updated to 4117: device not accessible for testing.H6: investigation findings code updated to 3221: no findings available.H6: investigation conclusions code updated to 4315: cause not established.H10: additional narratives/data.
Event or Problem Description
The patient underwent a revision surgery, on (b)(6) 2022, due to their canal-filling segmental stem loosening.During the revision surgery dr.(b)(6) removed and replaced the following components: eleos distal femur, eleos tibial poly spacer, eleos tibial hinge component, eleos male-female midsection and eleos distal femur axial pin.Additionally, dr.(b)(6) removed a eleos canal-filling segmental stem and placed a eleos modular collar cemented segmental stem.There were no reported alleged deficiencies with the eleos distal femur, eleos tibial poly spacer, eleos tibial hinge component, eleos male-female midsection and eleos distal femur axial pin.It was reported that the surgeon plans to have another revision surgery.No revision surgery has been scheduled yet.No additional information regarding this adverse event has been provided.

• Brand Name: ELEOS
• Common Device Name: CANAL FILLING STEM, 13MMX120MM, STRAIGHT, SPLINED, FULL PLASMA, 28MM COLLAR
• Manufacturer (Section D): ONKOS SURGICAL; 77 east halsey road; parsippany NJ 07054
• Manufacturer (Section G): PHILLIPS PRECISION INC; 7 paul kohner place; elmwood park NJ 07407
• Manufacturer Contact: danielle pierce ; 77 east halsey road; parsippany 07054 ; 8447672766
• MDR Report Key: 13538687
• Report Number: 3013450937-2022-00086
• Device Sequence Number: 14783442
• Product Code: KRO
• UDI-Device Identifier: B278FS1312003M0
• UDI-Public: B278FS1312003M0
• Combination Product (Y/N): N
• Initial Reporter State: GA
• 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): 04/20/2022

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: FS-13120-03M
• Device Catalogue Number: FS-13120-03M
• Device Lot Number: 85212
• 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: 01/20/2022
• Supplement Date Received by Manufacturer: 04/20/2022
• Initial Report FDA Received Date: 02/15/2022
• Supplement Report FDA Received Date: 04/20/2022
• 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: 25000007E ELEOS DISTAL FEMUR LEFT SEGMENTAL; 25001060E MALE-FEMALE MIDSECTION 60MM; 25001208E ELEOS TIBIAL POLY SPACER 8MM; 25002111E ELEOS DISTAL FEMUR AXIAL PIN; 25002203E ELEOS TIBIAL BASEPLATE SIZE 3; KSP12140E ELEOS STEM EXTENSION CANAL FILLING; THSMWRS01M ELEOS TIBIAL HINGE W/ ROTATIONAL STOP
• Outcome Attributed to Adverse Event: Required Intervention; Hospitalization
• Patient Age: 59 YR
• Patient Sex: Female