MAUDE Adverse Event Report: ONKOS SURGICAL ELEOS; CANAL FILLING, 15MM X120MM, STRAIGHT, SPLINED, FULL PLASMA, 32MM COLLAR

Model Number	FS-15120-03M
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Unspecified Infection (1930); Insufficient Information (4580)
Date of Event	01/05/2022
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.Multiple mdrs were submitted for this adverse event: 3013450937-2022-00046, 3013450937-2022-00047, 3013450937-2022-00048, 3013450937-2022-00049, 3013450937-2022-00050, 3013450937-2022-00051 and 3013450937-2022-00052.
Event or Problem Description
It was reported that the patient presented with an alleged disassociated stem on the resurfacing femur and an alleged infection on (b)(6) 2022, after receiving a proximal tibia replacement surgery on (b)(6) 2020.The implanting surgeon performed revision surgeries on the patient to wash the patient out on (b)(6) 2022.The surgeon also performed a revision surgery on (b)(6) 2022 to remove all the implants that were implanted on (b)(6) 2020 during the original the proximal tibia replacement surgery.It was also reported that the surgeon plans to put in replacement implants when the infection clears up.No revision surgery to do this has been scheduled yet.No additional information regarding this adverse event has been provided.
Event or Problem Description
It was reported that the patient presented with an alleged disassociated stem on the resurfacing femur and an alleged infection on (b)(6) 2022, after receiving a proximal tibia replacement surgery on (b)(6) 2020.The implanting surgeon performed revision surgeries on the patient to wash the patient out on (b)(6) 2022 and (b)(6) 2022.The surgeon also performed a revision surgery on (b)(6) 2022 to remove all the implants that were implanted on (b)(6) 2020 during the original the proximal tibia replacement surgery.It was also reported that the surgeon plans to put in replacement implants when the infection clears up.No revision surgery to do this 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 alleged implant loosening could not be determined.If any additional information is obtained, a supplemental mdr will be filed accordingly.

• Brand Name: ELEOS
• Common Device Name: CANAL FILLING, 15MM X120MM, STRAIGHT, SPLINED, FULL PLASMA, 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 07054 ; 8447672766
• MDR Report Key: 13458661
• Report Number: 3013450937-2022-00053
• Device Sequence Number: 17588998
• Product Code: KRO
• UDI-Device Identifier: B278FS1512003M0
• UDI-Public: B278FS1512003M0
• Combination Product (Y/N): N
• Initial Reporter State: MI
• Initial Reporter Country: US
• PMA/510(K) Number: K161520
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2020
• 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): 04/06/2022

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: 01/18/2024
• Device Model Number: FS-15120-03M
• Device Catalogue Number: FS-15120-03M
• Device Lot Number: 81695
• 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: 01/05/2022
• Supplement Date Received by Manufacturer: 04/06/2022
• Initial Report FDA Received Date: 02/04/2022
• Supplement Report FDA Received Date: 04/06/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 01/18/2019
• 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: P/N 25001040E MALE-FEMALE MIDSECTION 40MM.; P/N 25001210E ELEOS TIBIAL POLY SPACER 10MM.; P/N 25002101E ELEOS TIBIAL HINGE COMPONENT.; P/N 25002114E ELEOS RESURFACING FEMUR AXIAL PIN 4.; P/N 25002200E ELEOS PROXIMAL TIBIA 87MM RESECTION.; P/N 2500L004E ELEOS RESURFACING FEMUR 4.; P/N KSP20100E ELEOS STEM EXTENSION, CANAL FILLING.
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention
• Patient Age: 42 YR
• Patient Sex: Male