MAUDE Adverse Event Report: ONKOS SURGICAL ELEOS; SEGMENTAL STEM, CANAL FILLING, SIZE 15MM X 152MM, STRAIGHT SLOTTED SPLINED

Model Number	SPSE0004E
Medical Device Problem Code	Loosening of Implant Not Related to Bone-Ingrowth (4002)
Health Effect - Clinical Code	Insufficient Information (4580)
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.Mulitple mdrs were submitted for this adverse event: 3013450937-2022-000219.
Event or Problem Description
It was reported that the patient presented with a fractured eleos tibial hinge w/ rotational stop and a loosened eleos canal filling segmental stem that occurred after the patient fell in the shower.The implanting surgeon performed a revision surgery on (b)(6) 2022.During the revision surgery the following implants were implanted: eleos cemented segmental stem, eleos distal femur, eleos tibial poly spacer 8mm, eleos male-female midsection 60mm, eleos distal femur axial pin, eleos male-female midsection 90mm, and eleos tibial hinge w/ rotational stop.No additional information regarding this adverse event has been provided.
Event or Problem Description
It was reported that the patient presented with a fractured eleos tibial hinge w/ rotational stop and a loosened eleos canal filling segmental stem that occurred after the patient fell in the shower.The implanting surgeon performed a revision surgery on (b)(6) 2022.During the revision surgery the following implants were implanted: eleos cemented segmental stem, eleos distal femur, eleos tibial poly spacer 8mm, eleos male-female midsection 60mm, eleos distal femur axial pin, eleos male-female midsection 90mm, and eleos tibial hinge w/ rotational stop.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 event could not be determined.If any additional information is obtained, a supplemental mdr will be filed accordingly.

• Brand Name: ELEOS
• Common Device Name: SEGMENTAL STEM, CANAL FILLING, SIZE 15MM X 152MM, STRAIGHT SLOTTED SPLINED
• Manufacturer (Section D): ONKOS SURGICAL; 77 e halsey rd; parsippany NJ 07054
• Manufacturer (Section G): MICROPORT ORTHOPEDICS; 5677 airline road; arlington TN 38002
• Manufacturer Contact: danielle pierce ; 77 east halsey road; parsippany, NJ 07054 ; 8447672766
• MDR Report Key: 15216637
• Report Number: 3013450937-2022-00218
• Device Sequence Number: 17703386
• Product Code: KRO
• UDI-Device Identifier: B278SPSE0004E0
• UDI-Public: B278SPSE0004E0
• Combination Product (Y/N): N
• Initial Reporter State: TN
• Initial Reporter Country: US
• PMA/510(K) Number: K161520
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2022
• 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): 10/14/2022

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
• Device Expiration Date: 07/20/2025
• Device Model Number: SPSE0004E
• Device Catalogue Number: SPSE0004E
• Device Lot Number: 1701341
• 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: 07/14/2022
• Supplement Date Received by Manufacturer: 10/12/2022
• Initial Report FDA Received Date: 08/12/2022
• Supplement Report FDA Received Date: 10/14/2022
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 07/20/2017
• 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; 25001050E ELEOS MALE-FEMALE MIDESECTION 50MM; 25001110E ELEOS MALE-FEMALE MISECTION 110MM; 25001212E ELEOS TIBIAL POLY SPACE 12MM; 25002111E ELEOS DISTAL FEMUR AXIAL PIN; THSMWRS01M ELEOS TIBIAL HINGE W/ ROTATIONAL STOP
• Outcome Attributed to Adverse Event: Required Intervention; Hospitalization
• Patient Age: 73 YR
• Patient Sex: Male