MAUDE Adverse Event Report: ONKOS SURGICAL ELEOS; STEM EXTENSION, CEMENTED, 12MM X100MM, STRAIGHT, FLUTED

Model Number	KSC12100E
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Fall (1848); Unspecified Infection (1930); Insufficient Information (4580)
Date of Event	01/10/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
On 10 jan 2022, it was reported that the patient had an alleged fall that contributed to an alleged infection they presented with after receiving total femoral replacement surgery on (b)(6) 2021.The implanting surgeon performed a distal femur revision surgery on (b)(6) 2022 and the following implants were revised: eleos tibial hinge component w/o rotational stop, eleos tibial baseplate size 3, eleos distal femur axial pin, eleos tibial poly spacer 8mm and eleos distal femur.The following implants remain implanted in the patient: eleos stem extension cemented 12mm x100mm straight fluted, eleos male-female midsection 50mm, eleos male-female midsection 40mm, eleos male-female midsection 40mm, eleos proximal femur 98mm left 135 deg, and eleos male-male midsection 40mm.It was reported that the surgeon plans to have one more revision surgery when the infection clears up.No revision surgery has been scheduled yet.No additional information regarding this adverse event has been provided.
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: 3013450937-2022-00064, 3013450937-2022-00065, 3013450937-2022-00066, 3013450937-2022-00067, 3013450937-2022-00068, 3013450937-2022-00069, 3013450937-2022-00070, 3013450937-2022-00071, 3013450937-2022-00072 and 3013450937-2022-00073.
Event or Problem Description
On (b)(6) 2022, it was reported that the patient had an alleged fall that contributed to an alleged infection they presented with after receiving total femoral replacement surgery on (b)(6) 2021.The implanting surgeon performed a distal femur revision surgery on (b)(6) 2022 and the following implants were revised: eleos tibial hinge component w/o rotational stop, eleos tibial baseplate size 3, eleos distal femur axial pin, eleos tibial poly spacer 8mm and eleos distal femur.The following implants remain implanted in the patient: eleos stem extension cemented 12mm x100mm straight fluted, eleos male-female midsection 50mm, eleos male-female midsection 40mm, eleos male-female midsection 40mm, eleos proximal femur 98mm left 135 deg, and eleos male-male midsection 40mm.It was reported that the surgeon plans to have one more revision surgery when the infection clears up.No revision surgery has been scheduled yet.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 patient fall and alleged infection 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: investigation findings code updated to 3221: no findings available.H6: investigation conclusions code updated to 4315: cause not established.H10: additional narratives/data.

• Brand Name: ELEOS
• Common Device Name: STEM EXTENSION, CEMENTED, 12MM X100MM, STRAIGHT, FLUTED
• Manufacturer (Section D): ONKOS SURGICAL; 77 east halsey road; parsippany NJ 07054
• Manufacturer (Section G): MICROPORT ORTHOPEDICS; 5677 airline road; arlington TN 38002
• Manufacturer Contact: danielle pierce ; 77 east halsey road; parsippany 07054 ; 8447672766
• MDR Report Key: 13500640
• Report Number: 3013450937-2022-00063
• Device Sequence Number: 3952511
• Product Code: KRO
• UDI-Device Identifier: B278KSC12100E0
• UDI-Public: B278KSC12100E0
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: K161520
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted 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): 04/10/2022

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: 03/21/2025
• Device Model Number: KSC12100E
• Device Catalogue Number: KSC12100E
• Device Lot Number: 1697272
• 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: 01/10/2022
• Supplement Date Received by Manufacturer: 04/10/2022
• Initial Report FDA Received Date: 02/09/2022
• Supplement Report FDA Received Date: 04/10/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 03/21/2017
• 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.; 25001040E ELEOS MALE-FEMALE MIDSECTION 40MM.; 25001040E ELEOS MALE-FEMALE MIDSECTION 40MM.; 25001050E ELEOS MALE-FEMALE MIDSECTION 50MM.; 25001208E ELEOS TIBIAL POLY SPACER 8MM.; 25002101E ELEOS TIBIAL HINGE W/O ROTAIONAL STOP.; 25002111E ELEOS DISTAL FEMUR AXIAL PIN.; 25002203E ELEOS TIBIAL BASEPLATE SIZE 3.; MS-040MM-02M ELEOS MALE-MALE MIDSECTION 40MM.; PF-2000L-02M ELEOS PROXIMAL FEMUR 98MM LEFT 135DEG.
• Outcome Attributed to Adverse Event: Required Intervention; Hospitalization
• Patient Age: 67 YR
• Patient Sex: Male