MAUDE Adverse Event Report: ONKOS SURGICAL ELEOS; CANAL FILLING STEM, 11MMX152MM, BOWED, SLOTTED, SPLINED, 2/3 PLASMA, 28MM COLLAR

Model Number	FB-11152-03M
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	01/11/2022
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
It was reported that the patient presented with a broken stem (b)(6) 2022 after receiving distal femoral replacement surgery on (b)(6) 2019.The implanting surgeon performed a revision surgery on (b)(6) 2022.During the revision surgery the following implants were revised: eleos distal femur right segmental, eleos distal femur axial pin, eleos tibial hinge component w/ rotational stop, and eleos tibial poly spacer 8mm.Also, during the revision surgery, the eleos canal filling stem 11mm 152mm bowed slotted spline 2/3 plasma 28mm collar was replaced with the eleos cemented stem 13mmx120mm straight fluted, eleos modular porous biogrip ha collar porous ha treated round 34mm 28mm, and eleos modular collar locking ring and impactor tip.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 complaint could not be determined.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.G4: pma/510(k) number corrected.G6: type of report added.H2: follow-up type added.H3: device evaluated by manufacturer updated to no and if other specify section corrected.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
It was reported that the patient presented with a broken stem on (b)(6) 2022 after receiving distal femoral replacement surgery on (b)(6) 2019.The implanting surgeon performed a revision surgery on (b)(6) 2022.During the revision surgery the following implants were revised: eleos distal femur right segmental, eleos distal femur axial pin, eleos tibial hinge component w/ rotational stop, and eleos tibial poly spacer 8mm.Also, during the revision surgery, the eleos canal filling stem 11mm 152mm bowed slotted spline 2/3 plasma 28mm collar was replaced with the eleos cemented stem 13mmx120mm straight fluted, eleos modular porous biogrip ha collar porous ha treated round 34mm 28mm, and eleos modular collar locking ring and impactor tip.No additional information regarding this adverse event has been provided.

• Brand Name: ELEOS
• Common Device Name: CANAL FILLING STEM, 11MMX152MM, BOWED, SLOTTED, SPLINED, 2/3 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: 13501775
• Report Number: 3013450937-2022-00054
• Device Sequence Number: 3991626
• Product Code: KRO
• UDI-Device Identifier: B278FB1115203M0
• UDI-Public: B278FB1115203M0
• Combination Product (Y/N): N
• Initial Reporter State: IA
• Initial Reporter Country: US
• PMA/510(K) Number: K161520
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• 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): 04/11/2022

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 Expiration Date: 03/04/2024
• Device Model Number: FB-11152-03M
• Device Catalogue Number: FB-11152-03M
• Device Lot Number: 82291
• 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: 01/11/2022
• Supplement Date Received by Manufacturer: 04/11/2022
• Initial Report FDA Received Date: 02/09/2022
• Supplement Report FDA Received Date: 04/11/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 03/04/2019
• 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: 25000009E ELEOS DISTAL FEMUR, RIGHT, SEGMENTAL; 25001208E ELEOS TIBIAL POLY SPACER 8MM; 25002100E ELEOS TIBIAL HINGE COMPONENT W/ STOP; 25002111E ELEOS DISTAL FEMUR AXIAL PIN; 25002202E ELEOS TIBIAL BASEPLATE SIZE 2; KSC01065E ELEOS STEM EXTENSION CEMENTED 10MMX65MM
• Outcome Attributed to Adverse Event: Required Intervention; Hospitalization
• Patient Sex: Unknown