MAUDE Adverse Event Report: ONKOS SURGICAL ELEOS; 11MM X 255MM, BOWED, FLUTED, 32MM COLLAR

Model Number	CB-11255-03M
Medical Device Problem Codes	Adverse Event Without Identified Device or Use Problem (2993); Loosening of Implant Not Related to Bone-Ingrowth (4002)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	01/27/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
The patient presented with a loosened eleos distal femoral segmental stem.A revision surgery was performed on (b)(6) 2023 to replace the eleos distal femoral stem with a depuy reclaim stem and onkos surgical my3d eleos x depuy reclaim coupler with onkos surgical my3d depuy reclaim retention bolt.
Additional Manufacturer Narrative
The investigation is in progress.When it is complete a supplemental mdr will be submitted accordingly.3013450937-2018-00070 was previously reported for the same patient.
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 implant loosening 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 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: 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 4109: historical data analysis 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 presented with a loosened eleos distal femoral segmental stem.A revision surgery was performed on (b)(6) 2023 to replace the eleos distal femoral stem with a depuy reclaim stem and onkos surgical my3d eleos x depuy reclaim coupler with onkos surgical my3d depuy reclaim retention bolt.

• Brand Name: ELEOS
• Common Device Name: 11MM X 255MM, BOWED, FLUTED, 32MM 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, NJ 07054 ; 8447672766
• MDR Report Key: 16691761
• Report Number: 3013450937-2023-00053
• Device Sequence Number: 6080638
• Product Code: KRO
• UDI-Device Identifier: B278CB1125503M0
• UDI-Public: B278CB1125503M0
• Combination Product (Y/N): N
• Initial Reporter State: SC
• 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: 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): 06/29/2023

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 Expiration Date: 03/04/2024
• Device Model Number: CB-11255-03M
• Device Catalogue Number: CB-11255-03M
• Device Lot Number: 82290
• 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: 01/27/2022
• Supplement Date Received by Manufacturer: 06/01/2023
• Initial Report FDA Received Date: 04/06/2023
• Supplement Report FDA Received Date: 06/29/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 02/15/2019
• 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
• Outcome Attributed to Adverse Event: Hospitalization
• Patient Age: 76 YR
• Patient Sex: Male