MAUDE Adverse Event Report: ONKOS SURGICAL ELEOS; CANAL-FILLING STRAIGHT SEGMENTAL STEM, 17X120MM

Model Number	FS-17120-03M
Medical Device Problem Code	Loosening of Implant Not Related to Bone-Ingrowth (4002)
Health Effect - Clinical Codes	Joint Laxity (4526); Insufficient Information (4580)
Date of Event	08/14/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The investigation is in process.When the investigation is complete, a supplemental mdr will be submitted accordingly.
Event or Problem Description
The patient underwent a revision surgery on (b)(6) 2023 due to a suspected loosening of their 17x120mm straight canal-filling segmental stem.During the revision surgery, the patient's 17x120mm straight canal-filling segmental stem was revised to a 20x120mm straight canal-filling segmental stem.The following eleos implants were also revised: distal femur, distal femur axial pin, tibial hinge component, tibial baseplate, cemented stem extension, tibial block augments, and tibial poly spacer.There were no reported malfunctions of the distal femur, distal femur axial pin, tibial hinge component, tibial baseplate, cemented stem extension, tibial block augments, and tibial poly spacer.No additional information regarding this adverse event have been reported.
Additional Manufacturer Narrative
The patient underwent a revision surgery on (b)(6) 2023 due to a suspected loosening of their 17x120mm straight canal-filling segmental stem.During the revision surgery, the patient's 17x120mm straight canal-filling segmental stem was revised to a 20x120mm straight canal-filling segmental stem.The following eleos implants were also revised: distal femur, distal femur axial pin, tibial hinge component, tibial baseplate, cemented stem extension, tibial block augments, and tibial poly spacer.There were no reported malfunctions of the distal femur, distal femur axial pin, tibial hinge component, tibial baseplate, cemented stem extension, tibial block augments, and tibial poly spacer.A review of the work order and sterilization batch release record for the product involved found no indication that the implant loosening was a result of a manufacturing or sterilization nonconformance.The eleos complaint history record was reviewed, which found 23 previous complaints for canal filling segmental stem loosenings.The root cause for the canal filling segmental stem loosening could not be determined.Based upon the review of the device history records and sterilization records, the investigation concluded that the root cause of the canal filling segmental.

• Brand Name: ELEOS
• Common Device Name: CANAL-FILLING STRAIGHT SEGMENTAL STEM, 17X120MM
• Manufacturer (Section D): ONKOS SURGICAL; 77 east halsey road; parsippany NJ 07054
• Manufacturer (Section G): PHILLIPS PRECISION INC; 7 paul kohner pl; elmwood park NJ 07407
• Manufacturer Contact: vandita patel ; 77 east halsey road; parsippany, NJ 07054 ; 8447672766
• MDR Report Key: 17712118
• Report Number: 3013450937-2023-00203
• Device Sequence Number: 19380489
• Product Code: KRO
• UDI-Device Identifier: B278FS1712003M0
• UDI-Public: B278FS1712003M0
• Combination Product (Y/N): N
• Initial Reporter State: AZ
• 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: 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): 09/08/2023

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: 01/18/2024
• Device Model Number: FS-17120-03M
• Device Catalogue Number: FS-17120-03M
• Device Lot Number: 81697
• 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: 08/10/2023
• Supplement Date Received by Manufacturer: 10/17/2023
• Initial Report FDA Received Date: 09/08/2023
• Supplement Report FDA Received Date: 12/06/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 01/18/2018
• 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 25000007E, ELEOS DISTAL FEMUR; P/N 25001216E, ELEOS POLY SPACER; P/N 25002111E, ELEOS DISTAL FEMUR AXIAL PIN; P/N KSC01530E, ELEOS STEM EXTENSION; P/N KTAGB415E, ELEOS TIBIAL BLOCK AUGMENT; P/N KTAGB415E, ELEOS TIBIAL BLOCK AUGMENT; P/N TB-2204E-01M, ELEOS TIBIAL BASEPLATE; P/N THSMWRS01M, ELEOS TIBIAL HINGE COMPONENT
• Outcome Attributed to Adverse Event: Hospitalization
• Patient Age: 63 YR
• Patient Sex: Male