MAUDE Adverse Event Report: ONKOS SURGICAL ELEOS LIMB SALVAGE SYSTEM; CEMENTED, STRAIGHT FLUTED STEM, 17MM X 120MM

Model Number	HC-17120-03M
Medical Device Problem Code	Unintended Movement (3026)
Health Effect - Clinical Code	Pain (1994)
Date of Event	06/16/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that a patient experienced loosening of their implanted eleos cemented segmental stem.The patient was revised on (b)(6) 2022 to remove and replace the following devices: eleos cemented segmental stem, eleos distal femur, eleos male-female midsection, eleos biogrip ha collar, distal femur axial pin, eleos tibial hinge w/ rotational stop, and eleos tibial polyspacer.This event will be considered as a serious injury due to the revision procedure.No issues were reported with the eleos distal femur, eleos male-female midsection, eleos biogrip ha collar, distal femur axial pin, eleos tibial hinge w/ rotational stop, and eleos tibial polyspacer; therefore, they are considered concomitant.This record captures the eleos cemented segmental stem.
Additional Manufacturer Narrative
It was reported that a 69-year-old patient experienced loosening of their implanted eleos cemented stem with modular biogrip collar, approximately 10 months post-operatively.The patient's index procedure took place on (b)(6) 2021, where the patient was implanted with the eleos distal femur system.An eleos canal filling segmental stem 21mm x 120mm was originally placed.The patient experienced loosening of the implanted stem, resulting in the patient's first revision procedure on (b)(6) 2021.This event was captured in pcr (b)(4), mfr# 3013450937-2021-00222.During the first revision procedure, the implanted stem was replaced with the eleos cemented stem with modular biogrip collar.Approximately 7 months post-operatively, the eleos cemented stem with modular biogrip collar loosened and the patient underwent their second revision procedure.This device was removed and replaced with the eleos cemented stem, bowed, fluted,13mm x 152mm.Device history records and sterilization batch records were reviewed for the device lot number and no issues were identified which were related to the design, manufacturing, and sterilization of the components.This is the first complaint for loosening on the eleos cemented segmental stems w/ modular biogrip collars.Therefore, a complaint trend was not identified.The root cause of this event cannot be determined conclusively; however, based on the previous investigation in pcr (b)(4) and the eleos ifu for modular collars, it is possible that the patient's obese size may have contributed to the stem loosening.From the eleos ifu for modular collars, it states that "patient selection should consider the following factors, which could lead to increased risk of failure and can be critical to the eventual success of the procedure: the patient's weight, activity level, and occupation.Implant longevity and stability may be affected by these variables.A heavy-weight patient can produce high loads on the prosthesis, which can lead to failure of the prosthesis.The surgeon must consider the ability and willingness of the patient to follow instructions and to control their weight and activity level.".
Event or Problem Description
It was reported that a patient experienced loosening of their implanted eleos cemented segmental stem.The patient was revised on (b)(6) 2022 to remove and replace the following devices: eleos cemented segmental stem, eleos distal femur, eleos male-female midsection, eleos biogrip ha collar, distal femur axial pin, eleos tibial hinge w/ rotational stop, and eleos tibial polyspacer.This event will be considered as a serious injury due to the revision procedure.No issues were reported with the eleos distal femur, eleos male-female midsection, eleos biogrip ha collar, distal femur axial pin, eleos tibial hinge w/ rotational stop, and eleos tibial polyspacer; therefore, they are considered concomitant.This record captures the loosened eleos cemented segmental stem.

• Brand Name: ELEOS LIMB SALVAGE SYSTEM
• Common Device Name: CEMENTED, STRAIGHT FLUTED STEM, 17MM X 120MM
• Manufacturer (Section D): ONKOS SURGICAL; 77 e halsey rd; parsippany NJ 07054
• Manufacturer (Section G): PHILLIPS PRECISION INC; 7 paul kohner pl; elmwood park NJ 07407
• Manufacturer Contact: upasana basnet ; 77 e halsey rd; parsippany, NJ 07054
• MDR Report Key: 14881528
• Report Number: 3013450937-2022-00195
• Device Sequence Number: 5189293
• Product Code: KRO
• UDI-Device Identifier: B278HC1712003M0
• UDI-Public: B278HC1712003M0
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: K203815
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2021
• Device Explanted Year: 2022
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 08/30/2022

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 Model Number: HC-17120-03M
• Device Catalogue Number: HC-17120-03M
• Device Lot Number: 84551-038
• 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: 05/31/2022
• Supplement Date Received by Manufacturer: 08/29/2022
• Initial Report FDA Received Date: 06/30/2022
• Supplement Report FDA Received Date: 08/30/2022
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 05/25/2021
• 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: Required Intervention
• Patient Age: 70 YR
• Patient Sex: Female